Prescription medicine
Nizatidine First approved as Axid
Nizatidine (Axid) is a prescription medicine with an FDA approval on record since 1988. FDA's NDC Directory lists it from 4 generic labelers, and pharmacies paid $0.804 per nizatidine 150 mg capsule in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the nizatidine FDA label on DailyMed (effective January 2, 2025, Epic Pharma, LLC); the NDA 19508 record on Drugs@FDA; every nizatidine label on DailyMed.
Highlights of the record
FDA label of January 2, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageNizatidine capsules are indicated for up to 8 weeks for the treatment of active duodenal ulcer.
Forms and strengths
- 150 mg
- 300 mg
- 15 mg/ml
Capsule; solution.
On the market
- Earliest approval on file
- April 12, 1988 Axid, Smithkline Beecham; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 10 first July 5, 2002; 3 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 4 of which 4 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.804 per capsule Nizatidine 150 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 3 since 2020 0 Class I among all firms' recalls; latest April 15, 2020
- FAERS reports
- 1,516 through July 30, 2026
What is nizatidine used for?
From the label: indications and usageNizatidine 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. Nizatidine capsules are indicated for up to 12 weeks for the treatment of endoscopically diagnosed esophagitis, including erosive and ulcerative esophagitis, and associated heartburn due to GERD. […]
Conditions named in the indications of nizatidine's FDA labels, with every medicine labeled for each:
From other nizatidine labelsAcid reflux and ulcers: INDICATIONS AND USAGE Nizatidine capsules are indicated for up to 8 weeks for the treatment of active duodenal ulcer.
FDA pharmacologic class: Histamine-2 Receptor Antagonist.
Source: FDA drug label (Nizatidine), Epic Pharma, LLC, effective January 2, 2025 (SPL set e9957997-8b85-48a0-9bb3-b878cb223236), via openFDA; the full label on DailyMed
Is there a generic for nizatidine (Axid)?
The FDA approved the first generic nizatidine on July 5, 2002. 10 generic applications are approved; 3 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists nizatidine from 4 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1988 earliest approval on file
- 2002 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for nizatidine (Axid)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.804 per Nizatidine 150 mg capsule, up 2% from $0.791 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Nizatidine 150 mg capsule (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Nizatidine 150 mg capsule | Generic | $0.804 per capsule | $24.13 | +2% |
| Nizatidine 300 mg capsule | Generic | $0.799 per capsule | $23.96 | +3% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has nizatidine been recalled?
The FDA's Enforcement Report lists 3 recalls naming nizatidine since 2020: 0 Class I (the most serious), 3 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| April 15, 2020 | Class II | Amneal Pharmaceuticals of New York, LLC | CGMP Deviations: potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA. |
| January 7, 2020 | Class II | Mylan Pharmaceuticals Inc. | CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the nizatidine label say about other medicines?
The nizatidine label names 7 other medicines in its interaction, contraindication or warning sections. The labels of 8 other medicines name nizatidine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Aspirin | drug interactions | In patients given very high doses (3,900 mg) of aspirin daily, increases in serum salicylate levels were seen when nizatidine, 150 mg b.i.d., was administered concurrently. |
| Chlordiazepoxide | drug interactions | Drug Interactions No interactions have been observed between nizatidine and theophylline, chlordiazepoxide, lorazepam, lidocaine, phenytoin, and warfarin. |
| Lidocaine | drug interactions | Drug Interactions No interactions have been observed between nizatidine and theophylline, chlordiazepoxide, lorazepam, lidocaine, phenytoin, and warfarin. |
| Lorazepam | drug interactions | Drug Interactions No interactions have been observed between nizatidine and theophylline, chlordiazepoxide, lorazepam, lidocaine, phenytoin, and warfarin. |
| Phenytoin | drug interactions | Drug Interactions No interactions have been observed between nizatidine and theophylline, chlordiazepoxide, lorazepam, lidocaine, phenytoin, and warfarin. |
| Theophylline | drug interactions | Drug Interactions No interactions have been observed between nizatidine and theophylline, chlordiazepoxide, lorazepam, lidocaine, phenytoin, and warfarin. |
| Warfarin | drug interactions | Drug Interactions No interactions have been observed between nizatidine and theophylline, chlordiazepoxide, lorazepam, lidocaine, phenytoin, and warfarin. |
Other labels that name nizatidine
Source: FDA drug label (Nizatidine), Epic Pharma, LLC, effective January 2, 2025 (SPL set e9957997-8b85-48a0-9bb3-b878cb223236), via openFDA; the full label on DailyMed
What do FAERS reports show for nizatidine?
The FDA Adverse Event Reporting System holds 1,516 reports that list nizatidine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 159 are coded as a death and 573 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as nizatidine?
21 other medicines are given the same way (oral) and in the same FDA class as nizatidine or labeled mainly for the same use (acid reflux and ulcers), the same class first. Acid reflux and ulcers lists all 27 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Famotidine | Acid reflux and ulcers | 144 labelers | $0.0289 per tablet 20 mg tablet | No current entry |
| Calcium carbonate and famotidine and magnesium hydroxide | Acid reflux and ulcers | 20 labelers | $0.258 per tablet Acid reducer complete tablet chewable | No current entry |
| Cimetidine | Acid reflux and ulcers | 18 labelers | $0.236 per tablet 300 mg tablet | No current entry |
| Ranitidine | Acid reflux and ulcers | 8 labelers | n/a | No current entry |
| Calcium carbonate | Acid reflux and ulcers | none listed | $0.0315 per tablet 750 mg tablet chewable | No current entry |
| Omeprazole | Acid reflux and ulcers | 121 labelers | $0.0295 per capsule 20 mg capsule | A presentation being discontinued |
| Esomeprazole | Acid reflux and ulcers | 117 labelers | $0.145 per capsule 20 mg capsule | No current entry |
| Pantoprazole | Acid reflux and ulcers | 52 labelers | $0.0358 per tablet 40 mg tablet | No current entry |
Every medicine labeled for the same conditions as nizatidine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to nizatidine
- 21 medicines for the same use
- Other H2 blockers
- the pharmacologic class, with prices and generics
- Nizatidine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other