Quick answers
- What is Cimetidine used for?
- The FDA-approved label (Cimetidine, Mylan Pharmaceuticals Inc., July 15, 2026) says: “Cimetidine tablets are indicated in: 1. Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks and there is rarely reason to use cimetidine tablets at full dosage for longer than 6 to 8 weeks (see DOSAGE AND ADMINISTRATION: Duodenal Ulcer ). Concomitant antacids should be given as needed for relief of pain. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Cimetidine have a boxed warning?
- No. None of the 13 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Cimetidine?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Cimetidine been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Cimetidine?
- 12 companies list prescription products of Cimetidine in the FDA NDC Directory, including Chartwell RX, LLC, Aurobindo Pharma Limited and Bionpharma Inc..
What Cimetidine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Cimetidine tablets are indicated in: 1. Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks and there is rarely reason to use cimetidine tablets at full dosage for longer than 6 to 8 weeks (see DOSAGE AND ADMINISTRATION: Duodenal Ulcer ). Concomitant antacids should be given as needed for relief of pain. …
— FDA label: Cimetidine, Mylan Pharmaceuticals Inc., effective July 15, 2026. Read the full label on DailyMed →
The FDA has 13 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 13 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Solution |
|---|---|
| Route | Oral |
| Prescription products | 28 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 |
|---|---|---|
| cimetidine 200 mg tablet, film coated | Generic | $0.2045 per tablet |
| cimetidine 300 mg tablet, film coated | Generic | $0.2439 per tablet |
| cimetidine 400 mg tablet, film coated | Generic | $0.3144 per tablet |
| cimetidine 800 mg tablet, film coated | Generic | $0.6945 per tablet |
| cimetidine hydrochloride 300 mg/5 mL solution | Generic | $0.6160 per mL |
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.
- Chartwell RX, LLC5 products
- Aurobindo Pharma Limited4 products
- Bionpharma Inc.4 products
- Mylan Pharmaceuticals Inc.4 products
- Teva Pharmaceuticals USA, Inc.3 products
- A-S Medication Solutions2 products
- Bryant Ranch Prepack1 product
- PD-Rx Pharmaceuticals, Inc.1 product
- Proficient Rx LP1 product
- Northwind Health Company, LLC1 product
- Chartwell Governmental & Specialty RX, LLC.1 product
- PAI Holdings, LLC dba PAI Pharma1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (8)
- ANDA074151Teva · May 17, 1994
- ANDA074246Mylan · May 17, 1994
- ANDA074329Chartwell Molecules · May 17, 1994
- ANDA074463Teva · May 17, 1994
- ANDA074251Chartwell Molecular · December 22, 1994
- ANDA074664Pai Holdings Pharm · October 28, 1997
- ANDA218220Bionpharma · November 7, 2024
- ANDA218997Aurobindo Pharma Ltd · November 12, 2024
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Cimetidine, Mylan Pharmaceuticals Inc., effective July 15, 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 →