Prescription and over-the-counter medicine
Ranitidine First approved as Zantac
Ranitidine (Zantac) is a prescription and over-the-counter medicine with an FDA approval on record since 1983. On April 1, 2020 the FDA asked manufacturers to withdraw all ranitidine products from the U.S. market. FDA's NDC Directory lists it from 8 generic labelers.
- Generic listed
Check it at the source: the ranitidine FDA label on DailyMed (effective May 1, 2026, Amneal Pharmaceuticals of New York LLC); the NDA 18703 record on Drugs@FDA; every ranitidine label on DailyMed.
Highlights of the record
FDA label of May 1, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageRanitidine Tablets, USP are indicated in: Short-term treatment of active duodenal ulcer.
Forms and strengths
- 75 mg
- 150 mg
- 300 mg
- 15 mg/ml
Tablet; capsule; syrup; coated tablet; film-coated tablet.
On the market
- Earliest approval on file
- June 9, 1983 Zantac 300, Glaxo Grp Ltd; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 75 first July 31, 1997; 7 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 8 of which 8 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 47 since 2012 0 Class I among all firms' recalls; latest January 15, 2020; 2 more by firms not listed as its makers
- FAERS reports
- 230,803 through July 30, 2026
What is ranitidine used for?
From the label: indications and usageRanitidine Tablets, USP are indicated in: Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Studies available to date have not assessed the safety of ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. No placebo-controlled comparative studies have been carried out for periods of longer than 1 year. The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis). Short-term treatment of active, benign gastric ulcer. […]
Conditions named in the indications of ranitidine's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Histamine-2 Receptor Antagonist.
Source: FDA drug label (Ranitidine), Amneal Pharmaceuticals of New York LLC, effective May 1, 2026 (SPL set b38a3332-5c54-453f-aeb7-070f830955c2), via openFDA; the full label on DailyMed
Is there a generic for ranitidine (Zantac)?
The FDA approved the first generic ranitidine on July 31, 1997. 75 generic applications are approved; 7 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists ranitidine from 8 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.
- 1983 earliest approval on file
- 1997 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Is ranitidine still on the U.S. market?
The FDA asked manufacturers to withdraw all prescription and over-the-counter ranitidine products from the U.S. market on April 1, 2020: an impurity, N-nitrosodimethylamine (NDMA), can increase in the products over time and with storage at higher temperatures; the request covered the ranitidine products then on the market; FDA's NDC Directory lists ranitidine products again today, which this page does not establish as sold.
FDA's NDC Directory lists ranitidine from 8 labelers under FDA applications, all of them generic, as read October 8, 2026; a listing is the maker's registration, not proof that a product is sold. Status checked October 8, 2026.
Source: FDA announcement of April 1, 2020
Has ranitidine been recalled?
The FDA's Enforcement Report lists 49 recalls naming ranitidine since 2012: 0 Class I (the most serious), 46 Class II, 3 Class III; 8 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of ranitidine and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| January 15, 2020 | Class II | Direct Rx | CGMP Deviations: Presence of NDMA impurity detected in product. |
| January 14, 2020 | Class II | Spectrum Laboratory Products | CGMP Deviations: Presence of NDMA impurity detected in product. |
| January 10, 2020 | Class II | PD-Rx Pharmaceuticals, Inc. | CGMP Deviations: Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels. |
| January 7, 2020 | Class II | Appco Pharma LLC | CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API |
| January 6, 2020 | Class II | H J Harkins Company Inc dba Pharma Pac | CGMP Deviations: Presence of NDMA impurity detected in product. |
| December 26, 2019 | Class II | AAA Pharmaceutical, Inc. | CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API |
| December 20, 2019 | Class II | Denton Pharma, Inc. | CGMP Deviations: Presence of NDMA impurity detected in product. |
| December 13, 2019 | Class II | Granules India Limited | CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the ranitidine label say about other medicines?
The ranitidine label names no other medicine on this site. The labels of 35 other medicines name ranitidine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
Other labels that name ranitidine
Source: FDA drug label (Ranitidine), Amneal Pharmaceuticals of New York LLC, effective May 1, 2026 (SPL set b38a3332-5c54-453f-aeb7-070f830955c2), via openFDA; the full label on DailyMed
What do FAERS reports show for ranitidine?
The FDA Adverse Event Reporting System holds 230,803 reports that list ranitidine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 17,888 are coded as a death and 29,264 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 rose sharply in 2021 (116,080, against a median of 8,887 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
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 ranitidine?
21 other medicines are given the same way (oral) and in the same FDA class as ranitidine 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 |
| Nizatidine | Acid reflux and ulcers | 4 labelers | $0.804 per capsule 150 mg capsule | 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 ranitidine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does ranitidine compare with medicines for the same use?
8 side-by-side pages set ranitidine beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to ranitidine
- 21 medicines for the same use
- Other H2 blockers
- the pharmacologic class, with prices and generics
- Ranitidine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other