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Prescription medicine · generic available

Omeprazole and sodium bicarbonate

Drug class: Proton Pump Inhibitor

The FDA’s “Established Pharmacologic Class”: the group of medicines that work in a similar way.

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

Omeprazole and sodium bicarbonate key facts

Drug class
Proton Pump Inhibitor
Used for
Omeprazole and Sodium Bicarbonate capsules are indicated in adults for the: short-term treatment of active duodenal ulcer. (source)
Prescription or over the counter
Prescription (Rx) · some products also sold over the counter
Generic available
Yes
Typical pharmacy cost
$0.5863 per capsule (omeprazole 20 mg · sodium bicarbonate 1100 mg; NADAC)
Latest FDA recall
None listed

Sources: FDA label (October 6, 2025); FDA NDC Directory (October 30, 2026); CMS NADAC (November 4, 2026); FDA enforcement reports (October 27, 2026). Not medical advice.

Quick answers

What is Omeprazole and sodium bicarbonate used for?
The FDA-approved label (Omeprazole and Sodium Bicarbonate, Ajanta Pharma USA Inc., October 6, 2025) says: “Omeprazole and Sodium Bicarbonate capsules are indicated in adults for the: short-term treatment of active duodenal ulcer. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy. short-term treatment (4 to 8 weeks) of active benign gastric ulcer. treatment of heartburn and other symptoms associated with GERD for up to 4 weeks. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
What are the side effects of Omeprazole and sodium bicarbonate?
The “Adverse Reactions” section of the FDA label (Omeprazole and Sodium Bicarbonate, Ajanta Pharma USA Inc., October 6, 2025) begins: “The following serious adverse reactions are described below and elsewhere in labeling: Acute Tubulointerstitial Nephritis [see Warnings and Precautions (5.2)] Clostridium difficile -Associated Diarrhea [see Warnings and Precautions (5.4)] Bone Fracture [see Warnings and Precautions (5.5)] Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.6)] Cutaneous and Systemic Lupus Erythematosus [see Warnings and Precautions (5.7)] Cyanocobalamin (Vitamin B-12) Deficiency [see Warnings and Precautions (5.9)] Hypomagnesemia and Mineral Metabolism [see Warnings and Precautions (5.10)] Fundic Gland Polyps [see Warnings and Precautions (5.14)] Most common adverse reactions (≥2%) are: headache, abdominal pain, nausea, diarrhea, vomiting, and flatulence.” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
What are the drug interactions of Omeprazole and sodium bicarbonate?
The “Drug Interactions” section of the FDA label (Omeprazole and Sodium Bicarbonate, Ajanta Pharma USA Inc., October 6, 2025) begins: “Tables 6 and 7 include drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with omeprazole and instructions for preventing or managing them. Consult the labeling of concomitantly used drugs to obtain further information about interactions with PPIs.” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Omeprazole and sodium bicarbonate have a boxed warning?
No. None of the 11 FDA labels we found for this medicine has a boxed warning.
Is there a shortage of Omeprazole and sodium bicarbonate?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Omeprazole and sodium bicarbonate been recalled?
No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
Who makes Omeprazole and sodium bicarbonate?
11 companies list prescription products of Omeprazole and sodium bicarbonate in the FDA NDC Directory, including Ajanta Pharma USA Inc., Santarus, Inc. and ScieGen Pharmaceuticals, Inc.

What Omeprazole and sodium bicarbonate is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

Omeprazole and Sodium Bicarbonate capsules are indicated in adults for the: short-term treatment of active duodenal ulcer. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy. short-term treatment (4 to 8 weeks) of active benign gastric ulcer. treatment of heartburn and other symptoms associated with GERD for up to 4 weeks. …

— FDA label: Omeprazole and Sodium Bicarbonate, Ajanta Pharma USA Inc., effective October 6, 2025. Read the full label on DailyMed →

Label quoted: the one for the most common form (capsule, oral), Omeprazole and Sodium Bicarbonate, Ajanta Pharma USA Inc.; it covers 2 products in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.

The FDA has 11 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Conditions named on the label

These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.

Related medical specialties

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

The label quoted above has no boxed warning.

0 of 11 FDA labels for this medicine have a boxed warning.

Omeprazole and sodium bicarbonate side effects

Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.

The following serious adverse reactions are described below and elsewhere in labeling: Acute Tubulointerstitial Nephritis [see Warnings and Precautions (5.2)] Clostridium difficile -Associated Diarrhea [see Warnings and Precautions (5.4)] Bone Fracture [see Warnings and Precautions (5.5)] Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.6)] Cutaneous and Systemic Lupus Erythematosus [see Warnings and Precautions (5.7)] Cyanocobalamin (Vitamin B-12) Deficiency [see Warnings and Precautions (5.9)] Hypomagnesemia and Mineral Metabolism [see Warnings and Precautions (5.10)] Fundic Gland Polyps [see Warnings and Precautions (5.14)] Most common adverse reactions (≥2%) are: headache, abdominal pain, nausea, diarrhea, vomiting, and flatulence.

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(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Ajanta Pharma USA Inc. at 855-664-7744 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of Omeprazole and Sodium Bicarbonate capsules has been established, in part, based on oral studies of an oral delayed-release omeprazole product. Clinical Trials with Omeprazole In the U.S. clinical trial population of 465 adult patients, the adverse reactions summarized in Table 3 were reported to occur in 1% or more of patients on therapy with omeprazole. Table 3: Adverse Reactions Occurring in 1% or More of Adult Patients in US Clinical Trials of Omeprazole Therapy Omeprazole % (n = 465) Placebo % (n = 64) Ranitidine % (n = 195) Headache 7 6 8 Diarrhea 3 3 2 Abdominal Pain 2 3 3 Nausea 2 3 4 Upper Respiratory Infection (URI) 2 2 3 Dizziness 2 0 3 Vomiting 2 5 2 Rash 2 0 0 Constipation 1 0 0 Cough 1 0 2 Asthenia 1 2 2 Back Pain 1 0 1 Table 4 summarizes the adverse reactions that occurred in 1% or more of omeprazole-treated patients from international double-blind and open-label clinical trials in which 2,631 patients and subjects received omeprazole. Table 4: Adverse Reactions Occurring in 1% or More of Adult Patients in International Clinical Trials of Omeprazole Therapy Omeprazole % (n = 2631) Placebo % (n = 120) Abdominal Pain 5.2 3.3 Nausea 4.0 6.7 Diarrhea 3.7 2.5 Vomiting 3.2 10.0 Headache 2.9 2.5 Flatulence 2.7 5.8 Acid Regurgitation 1.9 3.3 Constipation 1.5 0.8 Asthenia 1.3 0.8 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of omeprazole and sodium bicarbonate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Omeprazole Body as a Whole: Hypersensitivity reactions, including anaphylaxis, anaphylactic shock, angioedema, bronchospasm, urticaria (see also Skin below), fever, pain, fatigue, malaise, and systemic lupus erythematosus. Cardiovascular: Chest pain or angina, tachycardia, bradycardia, palpitation, elevated blood pressure, and peripheral edema. Gastrointestinal: Pancreatitis (some fatal), anorexia, irritable colon, flatulence, fecal discoloration, esophageal candidiasis, mucosal atrophy of the tongue, dry mouth, stomatitis, abdominal swelling and fundic gland polyps.

Table from the label
Omeprazole % (n = 2631)Placebo % (n = 120)
Abdominal Pain5.23.3
Nausea4.06.7
Diarrhea3.72.5
Vomiting3.210.0
Headache2.92.5
Flatulence2.75.8
Acid Regurgitation1.93.3
Constipation1.50.8
Asthenia1.30.8

— FDA label: Omeprazole and Sodium Bicarbonate, Ajanta Pharma USA Inc., effective October 6, 2025. This is part of the section. Read the full label on DailyMed →

Omeprazole and sodium bicarbonate drug interactions

Quoted from the “Drug Interactions” section of the FDA-approved label. Tell your pharmacist about every medicine, vitamin and herbal product you take.

Tables 6 and 7 include drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with omeprazole and instructions for preventing or managing them. Consult the labeling of concomitantly used drugs to obtain further information about interactions with PPIs.

Read more of this section

Table 6: Clinically Relevant Interactions Affecting Drugs Co-Administered with Omeprazole and Interaction with Diagnostics Antiretrovirals Clinical Impact: The effect of PPIs on antiretroviral drugs is variable. The clinical importance and the mechanisms behind these interactions are not always known. Decreased exposure of some antiretroviral drugs (e.g., rilpivirine, atazanavir and nelfinavir) when used concomitantly with omeprazole may reduce antiviral effect and promote the development of drug resistance [see Clinical Pharmacology (12.3)]. Increased exposure of other antiretroviral drugs (e.g., saquinavir) when used concomitantly with omeprazole may increase toxicity [see Clinical Pharmacology (12.3)]. There are other antiretroviral drugs which do not result in clinically relevant interactions with omeprazole. Intervention: Rilpivirine-containing products: Concomitant use with Omeprazole and Sodium Bicarbonate capsules are contraindicated [see Contraindications (4)]. Atazanavir: Avoid concomitant use with Omeprazole and Sodium Bicarbonate capsules. See prescribing information for atazanavir for dosing information. Nelfinavir: Avoid concomitant use with Omeprazole and Sodium Bicarbonate capsules. See prescribing information for nelfinavir. Saquinavir: See the prescribing information for saquinavir for monitoring of potential saquinavir-related toxicities. Other antiretrovirals: See prescribing information for specific antiretroviral drugs. Warfarin Clinical Impact: Increased INR and prothrombin time in patients receiving PPIs, including omeprazole, and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death. Intervention: Monitor INR and prothrombin time and adjust the dose of warfarin, if needed, to maintain target INR range. Methotrexate Clinical Impact: Concomitant use of omeprazole with methotrexate (primarily at high dose) may elevate and prolong serum concentrations of methotrexate and/or its metabolite hydroxymethotrexate, possibly leading to methotrexate toxicities. No formal drug interaction studies of high-dose methotrexate with PPIs have been conducted [see Warnings and Precautions (5.12)]. Intervention: A temporary withdrawal of Omeprazole and Sodium Bicarbonate capsules may be considered in some patients receiving high-dose methotrexate. CYP2C19 Substrates (e.g., clopidogrel, citalopram, cilostazol, phenytoin, diazepam) Clopidogrel Clinical Impact: Concomitant use of omeprazole 80 mg results in reduced plasma concentrations of the active metabolite of clopidogrel and a reduction in platelet inhibition [see Clinical Pharmacology (12.3)].

— FDA label: Omeprazole and Sodium Bicarbonate, Ajanta Pharma USA Inc., effective October 6, 2025. This is part of the section. Read the full label on DailyMed →

Omeprazole and sodium bicarbonate dosage

Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.

* an additional 4 weeks of treatment may be given if no response; if recurrence, additional 4 to 8-week courses may be considered. ** studied for 12 months.

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Indication Recommended Adult Dosage Omeprazole and Sodium Bicarbonate capsules Active Duodenal Ulcer 20 mg once daily for 4 weeks; some patients may require an additional 4 weeks Active Benign Gastric Ulcer 40 mg once daily for 4 to 8 weeks Treatment of Symptomatic GERD 20 mg once daily for up to 4 weeks Treatment of EE due to Acid-Mediated GERD 20 mg once daily for 4 to 8 weeks* Maintenance of Healing of EE due to Acid-Mediated GERD 20 mg once daily** 2.1 Important Administration Instructions Omeprazole and Sodium Bicarbonate is available as a capsule in 20 mg and 40 mg strengths of omeprazole for adult use. All recommended doses throughout the labeling are based upon omeprazole. The sodium content of Omeprazole and Sodium Bicarbonate capsules should be taken into consideration when prescribing this product [see Warnings and Precautions (5.3)]: Omeprazole and Sodium Bicarbonate capsule: each 20 mg and 40 mg capsule contains 1,100 mg (13 mEq) of sodium bicarbonate. The total content of sodium in each capsule is 304 mg. Due to the sodium bicarbonate content of Omeprazole and Sodium Bicarbonate capsules: Do not substitute two 20 mg Omeprazole and Sodium Bicarbonate capsules with one 40 mg Omeprazole and Sodium Bicarbonate capsule. 2.2 Dosage Regimen The recommended dosage regimen by indication in adults of Omeprazole and Sodium Bicarbonate capsules is summarized in Table 1. All recommended dosages are based upon omeprazole content. Table 1: Recommended Dosage Regimen of Omeprazole and Sodium Bicarbonate Capsules in Adults by Indication 1. Most patients heal within 4 weeks. Some patients may require an additional 4 weeks of therapy [see Clinical Studies (14.1)]. 2. The efficacy of Omeprazole and Sodium Bicarbonate capsules used for longer than 8 weeks in patients with EE has not been established. If a patient does not respond to 8 weeks of treatment, an additional 4 weeks of treatment may be given. If there is recurrence of EE or GERD symptoms (e.g., heartburn), additional 4 to 8-week courses of Omeprazole and Sodium Bicarbonate capsules may be considered. Indication Dosage of Omeprazole and Sodium Bicarbonate capsules Treatment Duration Treatment of Active Duodenal Ulcer 20 mg once daily 4 weeks 1,2 Treatment of Active Benign Gastric Ulcer 40 mg once daily 4 to 8 weeks Treatment of Symptomatic GERD 20 mg once daily Up to 4 weeks Treatment of EE due to Acid-Mediated GERD 20 mg once daily 4 to 8 weeks 2 Maintenance of Healing of EE due to Acid-Mediated GERD 20 mg once daily Controlled studies do not extend beyond 12 months. 2.3 Preparation and Administration Omeprazole and Sodium Bicarbonate Capsules Swallow capsules intact with water. Do not open the capsule and do not administer with liquids other than water.

— FDA label: Omeprazole and Sodium Bicarbonate, Ajanta Pharma USA Inc., effective October 6, 2025. This is part of the section. Read the full label on DailyMed →

Omeprazole and sodium bicarbonate in pregnancy

Quoted from the pregnancy part of the FDA-approved label. Ask your doctor before you take any medicine while pregnant or planning a pregnancy.

Risk Summary There are no adequate and well-controlled studies with Omeprazole and Sodium Bicarbonate capsules in pregnant women. Omeprazole and Sodium Bicarbonate capsules contains omeprazole and sodium bicarbonate. Omeprazole There are no adequate and well-controlled studies with omeprazole in pregnant women.

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Available epidemiologic data fail to demonstrate an increased risk of major congenital malformations or other adverse pregnancy outcomes with first trimester omeprazole use. Reproduction studies in rats and rabbits resulted in dose-dependent embryo-lethality at omeprazole doses that were approximately 3.4 to 34 times an oral human dose of 40 mg (based on a body surface area for a 60 kg person). Teratogenicity was not observed in animal reproduction studies with administration of oral esomeprazole (an enantiomer of omeprazole) magnesium in rats and rabbits during organogenesis with doses about 68 times and 42 times, respectively, an oral human dose of 40 mg esomeprazole or 40 mg omeprazole (based on body surface area for a 60 kg person). Changes in bone morphology were observed in offspring of rats dosed through most of pregnancy and lactation at doses equal to or greater than approximately 34 times an oral human dose of 40 mg esomeprazole or 40 mg omeprazole. When maternal administration was confined to gestation only, there were no effects on bone physeal morphology in the offspring at any age (see Data). Sodium Bicarbonate Available data with sodium bicarbonate use in pregnant women are insufficient to identify a drug associated risk of major birth defects or miscarriage. Published animal studies report that sodium bicarbonate administered to rats, mice or rabbits during pregnancy did not cause adverse developmental effects in offspring. The estimated background risks of major birth defects and miscarriage for the indicated population are unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Human Data There are no adequate and well-controlled studies with Omeprazole and Sodium Bicarbonate capsules in pregnant women. Four published epidemiological studies compared the frequency of congenital abnormalities among infants born to women who used omeprazole during pregnancy with the frequency of abnormalities among infants of women exposed to H 2 -receptor antagonists or other controls. A population-based retrospective cohort epidemiological study from the Swedish Medical Birth Register, covering approximately 99% of pregnancies, from 1995-99, reported on 955 infants (824 exposed during the first trimester with 39 of these exposed beyond first trimester, and 131 exposed after the first trimester) whose mothers used omeprazole during pregnancy. The number of infants exposed in utero to omeprazole that had any malformation, low birth weight, low Apgar score, or hospitalization was similar to the number observed in this population.

— FDA label: Omeprazole and Sodium Bicarbonate, Ajanta Pharma USA Inc., effective October 6, 2025. This is part of the section. Read the full label on DailyMed →

When Omeprazole and sodium bicarbonate should not be used

Quoted from the “Contraindications” section of the FDA-approved label.

Omeprazole and Sodium Bicarbonate capsules are contraindicated in patients with known hypersensitivity to substituted benzimidazoles or to any components of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, and urticaria [see Warnings and Precautions (5.2), Adverse Reactions (6.2)].

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Proton pump inhibitors (PPIs), including Omeprazole and Sodium Bicarbonate capsules, are contraindicated in patients receiving rilpivirine containing products [see Drug Interactions (7)]. Known hypersensitivity to any components of the formulation (4) Patients receiving rilpivirine-containing products (4, 7)

— FDA label: Omeprazole and Sodium Bicarbonate, Ajanta Pharma USA Inc., effective October 6, 2025. Read the full label on DailyMed →

Omeprazole and sodium bicarbonate overdose

Quoted from the “Overdosage” section of the FDA-approved label. If someone may have taken too much, call Poison Help at 1-800-222-1222 (or 911 in an emergency).

If over-exposure occurs, call your Poison Control Center at 1-800-222-1222 for current information on the management of poisoning or overdosage. Omeprazole Reports have been received of overdosage with omeprazole in humans. Doses ranged up to 2,400 mg (120 times the usual recommended clinical dose).

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Manifestations were variable, but included confusion, drowsiness, blurred vision, tachycardia, nausea, vomiting, diaphoresis, flushing, headache, dry mouth, and other adverse reactions similar to those seen in clinical experience with the recommended dosage [see Adverse Reactions (6)]. Symptoms were transient, and no serious clinical outcome has been reported when omeprazole was taken alone. No specific antidote for omeprazole overdosage is known. Omeprazole is extensively protein bound and is, therefore, not readily dialyzable. In the event of overdosage, treatment should be symptomatic and supportive. Sodium Bicarbonate Overdosage of sodium bicarbonate can cause electrolyte abnormalities (hypocalcemia, hypokalemia, hypernatremia), metabolic alkalosis, and seizures. Institute supportive care and correct electrolyte abnormalities.

— FDA label: Omeprazole and Sodium Bicarbonate, Ajanta Pharma USA Inc., effective October 6, 2025. Read the full label on DailyMed →

Forms and how it is given

Dosage formsCapsule · Powder, for suspension · For suspension · Capsule, gelatin coated
RouteOral
Prescription products21 in the FDA NDC Directory
Brand namesZegerid

What pharmacies pay (NADAC)

The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.

This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.

NADAC per unit for Omeprazole and sodium bicarbonate, by strength and form
Strength and formGeneric or brandPharmacies pay
omeprazole 20 mg · sodium bicarbonate 1100 mg
capsule
Generic $0.5863 per capsule
omeprazole 20 mg · sodium bicarbonate 1680 mg
for suspension
Generic $8.15 per unit
omeprazole 20 mg · sodium bicarbonate 1680 mg
powder, for suspension
Generic $8.15 per unit
omeprazole 20 mg/1700 mg · sodium bicarbonate 1680 mg/1700 mg
powder, for suspension
Generic $8.15 per unit
omeprazole 40 mg · sodium bicarbonate 1100 mg
capsule
Generic $0.5549 per capsule
omeprazole 40 mg · sodium bicarbonate 1100 mg
capsule, gelatin coated
Generic $0.5549 per capsule
omeprazole 40 mg · sodium bicarbonate 1680 mg
for suspension
Generic $8.27 per unit
omeprazole 40 mg · sodium bicarbonate 1680 mg
powder, for suspension
Generic $8.27 per unit
omeprazole 40 mg/1720 mg · sodium bicarbonate 1680 mg/1720 mg
powder, for suspension
Generic $8.27 per unit

NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.

Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

FDA approval history

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
  • ANDA: Abbreviated New Drug Application: how a generic version is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA021636
ZEGERID
SalixJune 15, 2004 15, latest July 18, 2023
2023: Labeling · 2022: Labeling · 2020: Labeling

Generic approvals (6)

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.

Official identifiers

RxCUI (RxNorm)616539, 616541, 753557, 753562
SPL set ID of the quoted labelcb657607-b038-47ee-b4e7-a5f419a14c33
FDA labels (SPL)11
FDA applicationsNDA021636, 6 ANDA
Active ingredients (FDA)OMEPRAZOLE / SODIUM BICARBONATE

Next steps

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Omeprazole and Sodium Bicarbonate, Ajanta Pharma USA Inc., effective October 6, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

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