Quick answers
- What is Nizatidine used for?
- The FDA-approved label (Nizatidine, Epic Pharma, LLC, January 2, 2025) says: “Nizatidine capsules are indicated for up to 8 weeks for the treatment of active duodenal ulcer. In most patients, the ulcer will heal within 4 weeks. Nizatidine capsules are indicated for maintenance therapy for duodenal ulcer patients at a reduced dosage of 150 mg h.s. after healing of an active duodenal ulcer. The consequences of continuous therapy with nizatidine for longer than 1 year are not known. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Nizatidine have a boxed warning?
- No. None of the 4 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Nizatidine?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Nizatidine been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started April 15, 2020 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Nizatidine?
- 4 companies list prescription products of Nizatidine in the FDA NDC Directory, including Dr. Reddy's Laboratories Limited, Epic Pharma, LLC and Actavis Pharma, Inc..
What Nizatidine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Nizatidine capsules are indicated for up to 8 weeks for the treatment of active duodenal ulcer. In most patients, the ulcer will heal within 4 weeks. Nizatidine capsules are indicated for maintenance therapy for duodenal ulcer patients at a reduced dosage of 150 mg h.s. after healing of an active duodenal ulcer. The consequences of continuous therapy with nizatidine for longer than 1 year are not known. …
— FDA label: Nizatidine, Epic Pharma, LLC, effective January 2, 2025. Read the full label on DailyMed →
The FDA has 4 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 4 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Capsule · Solution |
|---|---|
| Route | Oral |
| Prescription products | 7 in the FDA NDC Directory |
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 |
|---|---|---|
| nizatidine 150 mg capsule | Generic | $0.8199 per capsule |
| nizatidine 300 mg capsule | Generic | $0.7988 per capsule |
NADAC list of November 4, 2026; these prices took effect between June 17, 2026 and 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.
- Dr. Reddy's Laboratories Limited2 products
- Epic Pharma, LLC2 products
- Actavis Pharma, Inc.2 products
- Amneal Pharmaceuticals LLC1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (4)
- ANDA076178Epic Pharma LLC · July 5, 2002
- ANDA075616Watson Labs · July 9, 2002
- ANDA077314DR Reddys Labs Ltd · September 15, 2005
- ANDA090576Amneal Pharms · November 18, 2009
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.
-
April 15, 2020 · Class II · Terminated · D-1253-2020
CGMP Deviations: potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL) USP 480 mL bottles, Rx Only Distributed by: Gemini Laboratories, LLC Bridgewater, NJ 08807 NDC 60846-301-15 — Amneal Pharmaceuticals of New York, LLC
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
| RxCUI (RxNorm) | 198041, 312025, 476872 |
|---|---|
| SPL set ID of the quoted label | e9957997-8b85-48a0-9bb3-b878cb223236 |
| FDA labels (SPL) | 4 |
| FDA applications | 4 ANDA |
| Active ingredients (FDA) | NIZATIDINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Nizatidine, Epic Pharma, LLC, effective January 2, 2025; 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 →