Quick answers
- What is Norethindrone acetate and ethinyl estradiol used for?
- The FDA-approved label (Norethindrone Acetate and Ethinyl Estradiol, Glenmark Pharmaceuticals Inc., USA, January 29, 2026) says: “Norethindrone acetate and ethinyl estradiol tablets are a combination of an estrogen and progestin indicated in a woman with a uterus for: • Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause • Prevention of Postmenopausal Osteoporosis 1.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause 1.2 Prevention of Postmenopausal Osteoporosis Limitation of Use When prescribing solely for …” 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 Norethindrone acetate and ethinyl estradiol?
- The “Adverse Reactions” section of the FDA label (Norethindrone Acetate and Ethinyl Estradiol, Glenmark Pharmaceuticals Inc., USA, January 29, 2026) begins: “The following serious adverse reactions are discussed elsewhere in the labeling: • Cardiovascular Disorders [see Boxed Warning, Warnings and Precautions (5.1)]. • Malignant Neoplasms [see Boxed Warning, Warnings and Precautions (5.2)]. Most common adverse reactions with norethindrone acetate and ethinyl estradiol tablets (incidence greater than or equal to 5 percent) are: headache, abdominal pain, breast pain, and edema (generalized).” … 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 Norethindrone acetate and ethinyl estradiol?
- The “Drug Interactions” section of the FDA label (Norethindrone Acetate and Ethinyl Estradiol, Glenmark Pharmaceuticals Inc., USA, January 29, 2026) begins: “In vitro and in vivo studies have shown that estrogens are metabolized partially by cytochrome P450 3A4 (CYP3A4). Therefore, inducers or inhibitors of CYP3A4 may affect estrogen and progestin drug metabolism.” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Norethindrone acetate and ethinyl estradiol have a boxed warning?
- Yes. The FDA label for Norethindrone Acetate and Ethinyl Estradiol has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Norethindrone acetate and ethinyl estradiol?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Norethindrone acetate and ethinyl estradiol been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started January 30, 2017 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Norethindrone acetate and ethinyl estradiol?
- 10 companies list prescription products of Norethindrone acetate and ethinyl estradiol in the FDA NDC Directory, including Glenmark Pharmaceuticals Inc., USA, Teva Pharmaceuticals USA, Inc. and Xiromed, LLC.
What Norethindrone acetate and ethinyl estradiol is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Norethindrone acetate and ethinyl estradiol tablets are a combination of an estrogen and progestin indicated in a woman with a uterus for: • Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause • Prevention of Postmenopausal Osteoporosis 1.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause 1.2 Prevention of Postmenopausal Osteoporosis Limitation of Use When prescribing solely for …
— FDA label: Norethindrone Acetate and Ethinyl Estradiol, Glenmark Pharmaceuticals Inc., USA, effective January 29, 2026. Read the full label on DailyMed →
Label quoted: the one for the most common form (tablet, oral), Norethindrone Acetate and Ethinyl Estradiol, Glenmark Pharmaceuticals Inc., USA; 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 16 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.
This label has a boxed warning. Read it on the full label →
13 of 16 FDA labels for this medicine have a boxed warning.
Norethindrone acetate and ethinyl estradiol boxed warning: what the label says
Quoted from the boxed warning of the FDA-approved label.
WARNING: CARDIOVASCULAR DISORDERS, PROBABLE DEMENTIA, BREAST CANCER, and ENDOMETRIAL CANCER Estrogen Plus Progestin Therapy Cardiovascular Disorders and Probable Dementia The Women’s Health Initiative (WHI) estrogen plus progestin substudy reported increased risks of pulmonary embolism (PE), deep vein thrombosis (DVT), stroke, and myocardial infarction (MI) in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral conjugated estrogens (CE) [0.625 mg] combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo [see Warnings and Precautions (5.1), and Clinical Studies (14.5)].
Read more of this section
The WHI Memory Study (WHIMS) estrogen plus progestin ancillary study of WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age and older during 4 years of treatment with daily CE (0.625 mg) combined with MPA (2.5 mg), relative to placebo. It is unknown whether this finding applies to younger postmenopausal women [see Warnings and Precautions (5.3), Use in Specific Populations (8.5), and Clinical Studies (14.6)]. Do not use estrogen plus progestogen therapy for the prevention of cardiovascular disease or dementia [see Warnings and Precautions (5.1, 5.3), and Clinical Studies (14.5, 14.6)]. Breast Cancer The WHI estrogen plus progestin substudy demonstrated an increased risk of invasive breast cancer [see Warnings and Precautions (5.2) and Clinical Studies (14.5)]. Only daily oral 0.625 mg CE and 2.5 mg MPA were studied in the estrogen plus progestin substudy of the WHI. Therefore, the relevance of the WHI findings regarding adverse cardiovascular events, dementia and breast cancer to lower CE plus other MPA doses, other routes of administration, or other estrogen plus progestogen products is not known. Without such data, it is not possible to definitively exclude these risks or determine the extent of these risks for other products. Discuss with your patient the benefits and risks of estrogen plus progestogen therapy, taking into account her individual risk profile. Prescribe estrogens with or without progestogens at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman. Estrogen-Alone Therapy Endometrial Cancer There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Adding a progestogen to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Perform adequate diagnostic measures, including directed or random endometrial sampling when indicated, to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding [see Warnings and Precautions (5.2)]. Cardiovascular Disorders and Probable Dementia The WHI estrogen-alone substudy reported increased risks of stroke and DVT in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral CE (0.625 mg)-alone, relative to placebo [see Warnings and Precautions (5.1) and Clinical Studies (14.5)]. The WHIMS estrogen-alone ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age and older during 5.2 years of treatment with daily CE (0.625 mg)-alone, relative to placebo.
— FDA label: Norethindrone Acetate and Ethinyl Estradiol, Glenmark Pharmaceuticals Inc., USA, effective January 29, 2026. This is part of the section. Read the full label on DailyMed →
Norethindrone acetate and ethinyl estradiol 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 discussed elsewhere in the labeling:
- Cardiovascular Disorders [see Boxed Warning, Warnings and Precautions (5.1)].
- Malignant Neoplasms [see Boxed Warning, Warnings and Precautions (5.2)]. Most common adverse reactions with norethindrone acetate and ethinyl estradiol tablets (incidence greater than or equal to 5 percent) are: headache, abdominal pain, breast pain, and edema (generalized).
Read more of this section
(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Glenmark Pharmaceuticals Inc., USA at 1 (888) 721-7115 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. Adverse reactions reported by ≥5 percent of women in controlled clinical studies of norethindrone acetate and ethinyl estradiol tablets are shown in Table 1. Table 1. Associated Adverse Reactions Reported by ≥5 Percent of Women by Body System * BODY SYSTEM/ Adverse Reaction Number (Percent) of Subjects Placebo Norethindrone Acetate and Ethinyl Estradiol Tablets 0.5/2.5 Norethindrone Acetate and Ethinyl Estradiol Tablets 1/5 N = 247 N = 244 N = 258 BODY AS A WHOLE 23 (12.8) 30 (16.9) 30 (15.7) Edema - Generalized 10 (4) 12 (4.9) 11 (4.3) Headache 12 (4.9) 14 (5.7) 16 (6.2) DIGESTIVE SYSTEM 8 (4.4) 17 (9.6) 25 (13.1) Abdominal Pain 3 (1.2) 13 (5.3) 14 (6.8) UROGENITAL SYSTEM 20 (11.1) 34 (19.2) 45 (23.6) Breast Pain 9 (3.6) 22 (9) 20 (7.8) *The total number of women for each body system may be less than the number of women with AEs in that body system because a women may have had more than one AE per body system 6.2 Postmarketing Experience The following additional adverse reactions have been identified during post-approval use of norethindrone acetate and ethinyl estradiol tablets. 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. Genitourinary System Changes in vaginal bleeding pattern and abnormal withdrawal bleeding or flow; breakthrough bleeding; spotting; increase in size of uterine leiomyomata, vaginitis, including vaginal candidiasis; change in amount of cervical secretion; changes in cervical ectropion; ovarian cancer; endometrial hyperplasia; endometrial cancer; uterine cancer; vaginal hemorrhage; ovarian cyst; irregular menstruation; metrorrhagia; menorrhagia; dysmenorrhea; uterine enlargement. Breasts Tenderness, enlargement, breast pain, nipple pain, nipple discharge, galactorrhea; fibrocystic breast changes; breast cancer; breast disorder; breast mass; breast enlargement. Cardiovascular Deep and superficial venous thrombosis; pulmonary embolism; thrombophlebitis; thrombosis; chest pain; myocardial infarction; cerebrovascular accident (stroke); transient ischemic attack; hemiparesis; increase in blood pressure; irregular heart rate; palpitations; dyspnea.
Table from the label
| BODY SYSTEM/ Adverse Reaction | Number (Percent) of Subjects | ||
|---|---|---|---|
| Placebo | Norethindrone Acetate and Ethinyl Estradiol Tablets 0.5/2.5 | Norethindrone Acetate and Ethinyl Estradiol Tablets 1/5 | |
| N = 247 | N = 244 | N = 258 | |
| BODY AS A WHOLE | 23 (12.8) | 30 (16.9) | 30 (15.7) |
| Edema - Generalized | 10 (4) | 12 (4.9) | 11 (4.3) |
| Headache | 12 (4.9) | 14 (5.7) | 16 (6.2) |
| DIGESTIVE SYSTEM | 8 (4.4) | 17 (9.6) | 25 (13.1) |
| Abdominal Pain | 3 (1.2) | 13 (5.3) | 14 (6.8) |
| UROGENITAL SYSTEM | 20 (11.1) | 34 (19.2) | 45 (23.6) |
| Breast Pain | 9 (3.6) | 22 (9) | 20 (7.8) |
— FDA label: Norethindrone Acetate and Ethinyl Estradiol, Glenmark Pharmaceuticals Inc., USA, effective January 29, 2026. This is part of the section. Read the full label on DailyMed →
Norethindrone acetate and ethinyl estradiol 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.
In vitro and in vivo studies have shown that estrogens are metabolized partially by cytochrome P450 3A4 (CYP3A4). Therefore, inducers or inhibitors of CYP3A4 may affect estrogen and progestin drug metabolism.
Read more of this section
Inducers of CYP3A4 such as St. John’s wort (Hypericum perforatum) preparations, phenobarbital, carbamazepine and rifampin may decrease the plasma concentration of estrogens and progestins, possibly resulting in a decrease in therapeutic effects and/or changes in the uterine bleeding profile. Inhibitors of CYP3A4 such as erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir and grapefruit juice may increase the plasma concentration of the estrogen or the progestin or both and may result in adverse reactions. Co-administration of atorvastatin and certain hormonal products containing ethinyl estradiol increase AUC values for ethinyl estradiol approximately 20 percent. Ascorbic acid and acetaminophen may increase the plasma ethinyl estradiol concentration, possibly by inhibition of conjugation. Combination hormonal products have been shown to significantly decrease the plasma concentration of lamotrigine likely due to induction of lamotrigine glucuronidation. This may reduce seizure control; therefore, dosage adjustments of lamotrigine may be necessary. Inducers and/or inhibitors of CYP3A4 may affect estrogen drug metabolism and decrease or increase the estrogen plasma concentration. (7.1)
— FDA label: Norethindrone Acetate and Ethinyl Estradiol, Glenmark Pharmaceuticals Inc., USA, effective January 29, 2026. Read the full label on DailyMed →
Norethindrone acetate and ethinyl estradiol 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.
Use estrogen, alone or in combination with a progestogen, at the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Re-evaluate postmenopausal women periodically as clinically appropriate to determine whether treatment is still necessary.
Read more of this section
- One tablet orally once daily (2.1, 2.2) 2.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause Take a single norethindrone acetate and ethinyl estradiol tablet, orally once daily. 2.2 Prevention of Postmenopausal Osteoporosis Take a single norethindrone acetate and ethinyl estradiol tablet, orally once daily
— FDA label: Norethindrone Acetate and Ethinyl Estradiol, Glenmark Pharmaceuticals Inc., USA, effective January 29, 2026. Read the full label on DailyMed →
Norethindrone acetate and ethinyl estradiol 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 Norethindrone acetate and ethinyl estradiol tablets are not indicated for use in pregnancy.
Read more of this section
There are no data with the use of norethindrone acetate and ethinyl estradiol tablets in pregnant women; however, epidemiologic studies and meta-analyses have not found an increased risk of genital or nongenital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to combined (estrogens and progestins) product before conception or during early pregnancy. 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.
— FDA label: Norethindrone Acetate and Ethinyl Estradiol, Glenmark Pharmaceuticals Inc., USA, effective January 29, 2026. Read the full label on DailyMed →
When Norethindrone acetate and ethinyl estradiol should not be used
Quoted from the “Contraindications” section of the FDA-approved label.
Norethindrone acetate and ethinyl estradiol tablets are contraindicated in women with any of the following conditions:
- Undiagnosed abnormal genital bleeding [see Warnings and Precautions (5.2)].
- Breast cancer or a history of breast cancer [see Warnings and Precautions (5.2)].
- Estrogen-dependent neoplasia [see Warnings and Precautions (5.2)].
- Active DVT, PE or a history of these conditions [see Warnings and Precautions (5.1)].
Read more of this section
- Active arterial thromboembolic disease (for example, stroke and MI), or a history of these conditions [see Warnings and Precautions (5.1)].
- Known anaphylactic reaction, angioedema, or hypersensitivity to norethindrone acetate and ethinyl estradiol tablets.
- Hepatic impairment or disease.
- Protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders.
- Undiagnosed abnormal genital bleeding (4, 5.2)
- Breast cancer or a history of breast cancer (4, 5.2)
- Estrogen-dependent neoplasia (4, 5.2)
- Active DVT, PE, or history of these conditions (4, 5.1)
- Active arterial thromboembolic disease (for example, stroke and MI), or a history of these conditions (4, 5.1)
- Known anaphylactic reaction, angioedema or hypersensitivity to norethindrone acetate and ethinyl estradiol tablets (4)
- Hepatic impairment or disease (4, 5.10)
- Protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders (4)
— FDA label: Norethindrone Acetate and Ethinyl Estradiol, Glenmark Pharmaceuticals Inc., USA, effective January 29, 2026. Read the full label on DailyMed →
Norethindrone acetate and ethinyl estradiol 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).
Overdosage of estrogen plus progestogen may cause nausea, vomiting, breast tenderness, abdominal pain, drowsiness and fatigue, and withdrawal bleeding may occur in women. Treatment of overdose consists of discontinuation of norethindrone acetate and ethinyl estradiol tablets therapy with institution of appropriate symptomatic care.
— FDA label: Norethindrone Acetate and Ethinyl Estradiol, Glenmark Pharmaceuticals Inc., USA, effective January 29, 2026. Read the full label on DailyMed →
Forms and how it is given
| Dosage forms | Tablet · Tablet, film coated |
|---|---|
| Route | Oral |
| Prescription products | 20 in the FDA NDC Directory |
| Brand names | Junel 21 Day, Loestrin 21 Day, Fyavolv, Luizza 1/20, Hailey 1.5/30, Aurovela 1/20, Luizza 1.5/30, Aurovela 1.5/30, Jinteli |
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.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| ethinyl estradiol 0.0025 mg · norethindrone acetate 0.5 mg tablet, film coated | Generic | $0.9351 per tablet |
| ethinyl estradiol 0.005 mg · norethindrone acetate 1 mg tablet, film coated | Generic | $0.6665 per tablet |
| ethinyl estradiol 0.02 mg · norethindrone acetate 1 mg tablet | Generic | $0.1760 per tablet |
| ethinyl estradiol 0.03 mg · norethindrone acetate 1.5 mg tablet | Generic | $0.3169 per tablet |
| ethinyl estradiol 2.5 ug · norethindrone acetate 0.5 mg tablet | Generic | $0.9351 per tablet |
| ethinyl estradiol 20 ug · norethindrone acetate 1 mg tablet | Generic | $0.1760 per tablet |
| ethinyl estradiol 30 ug · norethindrone acetate 1.5 mg tablet | Generic | $0.3169 per tablet |
| ethinyl estradiol 5 ug · norethindrone acetate 1 mg tablet | Generic | $0.6665 per tablet |
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.
- Glenmark Pharmaceuticals Inc., USA4 products
- Teva Pharmaceuticals USA, Inc.3 products
- Xiromed, LLC2 products
- Teva Women's Health LLC2 products
- Lupin Pharmaceuticals, Inc.2 products
- Aurobindo Pharma Limited2 products
- Mylan Pharmaceuticals Inc.2 products
- Proficient Rx LP1 product
- A-S Medication Solutions1 product
- Direct_Rx1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (11)
- ANDA076380Barr Labs · May 30, 2003
- ANDA076381Barr · May 30, 2003
- ANDA076221Barr Labs Inc · November 6, 2009
- ANDA202771Xiromed · November 6, 2013
- ANDA202770Xiromed · February 19, 2015
- ANDA203038Glenmark Pharms Ltd · April 2, 2015
- ANDA204213Lupin · December 10, 2015
- ANDA206969Glenmark Pharms Ltd · January 20, 2016
- ANDA207506Aurobindo Pharma · June 16, 2017
- ANDA207581Aurobindo Pharma · June 26, 2017
- ANDA209297Glenmark Speclt · June 5, 2018
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
January 30, 2017 · Class III · Terminated · D-0861-2017
Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint thinner used in repair of the manufacturing room.
Norethindrone Acetate and Ethinyl Estradiol Tablets, USP, 1 mg/0.02 mg, 1 blister pack containing 21 tablets (NDC 0378-7280-85), packaged in 3 pouches, each contains one blister pack of 21 tablets (NDC 0378-7280-53), Rx — Mylan Pharmaceuticals Inc.
-
March 15, 2013 · Class III · Terminated · D-682-2013
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Junel(TM) Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets), 28 day regimen, Rx only, Barr laboratories, Pomona, NY --- NDC 0555-9028-58 — Teva Pharmaceuticals USA, Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Next steps
- Find a pharmacy near youAsk which price applies to you and whether your product is affected by a recall
- Latest FDA drug recallsAll medicines, newest first
- Junel 21 DayBrand page: products, maker and price
- FyavolvBrand page: products, maker and price
- Aurovela 1.5/30Brand page: products, maker and price
- Aurovela 1/20Brand page: products, maker and price
- OsteoporosisCondition named on the label: hospitals that treat it
- Glenmark Pharmaceuticals Inc., USAMaker or distributor
- Teva Pharmaceuticals USA, Inc.Maker or distributor
- Xiromed, LLCMaker or distributor
- All prescription drugs A to ZSearch by generic, brand or Spanish name
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Norethindrone Acetate and Ethinyl Estradiol, Glenmark Pharmaceuticals Inc., USA, effective January 29, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- 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 →