Prescription and over-the-counter medicine
Famotidine Brand names: Pepcid
Famotidine (Pepcid) is a prescription and over-the-counter medicine with an FDA approval on record since 1986. FDA's NDC Directory lists it from 145 generic labelers, and pharmacies paid $0.0289 per famotidine 20 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the famotidine FDA label on DailyMed (effective February 6, 2026, Kenvue Brands LLC); the NDA 19462 record on Drugs@FDA; every famotidine label on DailyMed.
Highlights of the record
FDA label of February 6, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usagerelieves heartburn associated with acid indigestion and sour stomach prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages
Forms and strengths
- 10 mg
- 20 mg
- 40 mg
- 4 mg/ml
- 10 mg/ml
- 20 mg/50ml
- 40 mg/5ml
Film-coated tablet; tablet; powder for suspension; coated tablet; injection (solution).
On the market
- Earliest approval on file
- October 15, 1986 Pepcid, Bausch; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 88 first April 16, 2001; 60 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 147 of which 145 under generic applications, 3 under brand applications, repackagers included; 1 more under the over-the-counter monograph, without an application
Supply and safety
- Pharmacy cost (NADAC)
- $0.0289 per tablet Famotidine 20 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 14 since 2012 1 Class I among all firms' recalls; latest August 6, 2026; 1 more by firms not listed as its makers
- FAERS reports
- 118,838 through July 30, 2026
What is famotidine used for?
From the label: indications and usagerelieves heartburn associated with acid indigestion and sour stomach prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages
Conditions named in the indications of famotidine's FDA labels, with every medicine labeled for each:
From other famotidine labelsAcid reflux and ulcers: Uses relieves heartburn associated with acid indigestion and sour stomach prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages
FDA pharmacologic class: Histamine-2 Receptor Antagonist.
Source: FDA drug label (Pepcid AC Original Strength), Kenvue Brands LLC, effective February 6, 2026 (SPL set 54f4086f-e443-4e7e-8c7e-94e152e1c256), via openFDA; the full label on DailyMed
Is there a generic for famotidine (Pepcid)?
The FDA approved the first generic famotidine on April 16, 2001. 88 generic applications are approved; 60 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 3 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists famotidine from 145 labelers under a generic (ANDA) application and from 3 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1986 earliest approval on file
- 2001 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 famotidine (Pepcid)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0289 per Famotidine 20 mg tablet, down 2% from $0.0294 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.
- Famotidine 20 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Acid reducer 20 mg tablet | Generic | $0.138 per tablet | $4.15 | -6% |
| Famotidine 10 mg tablet | Generic | $0.0947 per tablet | $2.84 | -0.3% |
| Famotidine 20 mg tablet | Generic | $0.0289 per tablet | $0.866 | -2% |
| Famotidine 20 mg/2 mL vial | Generic | $0.303 per mL | $0.605 per vial | n/a |
| Famotidine 40 mg tablet | Generic | $0.0483 per tablet | $1.45 | -10% |
| Famotidine 40 mg/5 mL suspension | Generic | $0.130 per mL | n/a | -37% |
| Ft acid reducer 10 mg tablet | Generic | $0.0947 per tablet | $2.84 | -0.3% |
| Ft acid reducer 20 mg tablet | Generic | $0.138 per tablet | $4.15 | -6% |
| Gnp acid reducer 10 mg tablet | Generic | $0.0947 per tablet | $2.84 | -0.3% |
| Gnp acid reducer 20 mg tablet | Generic | $0.138 per tablet | $4.15 | -6% |
| Gs acid reducer 10 mg tablet | Generic | $0.0947 per tablet | $2.84 | -0.3% |
| Gs acid reducer 20 mg tablet | Generic | $0.138 per tablet | $4.15 | -6% |
| Heartburn relief 10 mg tablet | Generic | $0.0947 per tablet | $2.84 | -0.3% |
| Heartburn relief 20 mg tablet | Generic | $0.138 per tablet | $4.15 | -6% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has famotidine been recalled?
The FDA's Enforcement Report lists 15 recalls naming famotidine since 2012: 1 Class I (the most serious), 9 Class II, 5 Class III; 2 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of famotidine and that holds 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 |
|---|---|---|---|
| August 6, 2026 | Class II | Baxter Healthcare Corporation | CGMP Deviations |
| November 6, 2025 | Class I | Fresenius Kabi USA, LLC | Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing. |
| May 1, 2023 | Class II | Glenmark Therapeutics, Inc. | Labeling: Label Error on Declared Strength: some cartons labeled and containing 20 mg may have an external label placed on the side of the carton indicating … |
| January 20, 2021 | Class II | Aurobindo Pharma USA Inc. | Presence of foreign tablets/capsules: Famotidine 20mg and ibuprofen 400mg tablets were found in a lot of famotidine 40mg. |
| June 17, 2020 | Class III | HF Acquisition Co. LLC | TEMPERATURE ABUSE: Complaint received from customer that product was received in a non-refrigerated state. |
| October 3, 2017 | Class III | Dr. Reddy's Laboratories, Inc. | Failed impurities/degradation specifications: Famotodine has an out of specification result for an individual related substance observed during routine … |
| July 28, 2017 | Class II | PD-Rx Pharmaceuticals, Inc. | Failed Tablet/Capsule Specification: out of specification for tablet weight. |
| July 24, 2017 | Class II | Teva Pharmaceuticals USA | Failed Tablet/Capsule Specification; out of specification for tablet weight |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the famotidine label say about other medicines?
The famotidine label names 10 other medicines in its interaction, contraindication or warning sections. The labels of 30 other medicines name famotidine. 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 |
|---|---|---|
| Atazanavir | drug interactions (prescription label) | See the prescribing information for other drugs dependent on gastric pH for absorption for administration instructions, including atazanavir, erlotinib, ketoconazole, itraconazole, ledipasvir/sofosbuvir, nilotinib, and rilpivirine. |
| Dasatinib | drug interactions (prescription label) | Concomitant administration of famotidine with dasatinib, delavirdine mesylate, cefditoren, and fosamprenavir is not recommended. |
| Erlotinib | drug interactions (prescription label) | See the prescribing information for other drugs dependent on gastric pH for absorption for administration instructions, including atazanavir, erlotinib, ketoconazole, itraconazole, ledipasvir/sofosbuvir, nilotinib, and rilpivirine. |
| Fosamprenavir | drug interactions (prescription label) | Concomitant administration of famotidine with dasatinib, delavirdine mesylate, cefditoren, and fosamprenavir is not recommended. |
| Itraconazole | drug interactions (prescription label) | See the prescribing information for other drugs dependent on gastric pH for absorption for administration instructions, including atazanavir, erlotinib, ketoconazole, itraconazole, ledipasvir/sofosbuvir, nilotinib, and rilpivirine. |
| Ketoconazole | drug interactions (prescription label) | See the prescribing information for other drugs dependent on gastric pH for absorption for administration instructions, including atazanavir, erlotinib, ketoconazole, itraconazole, ledipasvir/sofosbuvir, nilotinib, and rilpivirine. |
| Ledipasvir and sofosbuvir | drug interactions (prescription label) | See the prescribing information for other drugs dependent on gastric pH for absorption for administration instructions, including atazanavir, erlotinib, ketoconazole, itraconazole, ledipasvir/sofosbuvir, nilotinib, and rilpivirine. |
| Nilotinib | drug interactions (prescription label) | See the prescribing information for other drugs dependent on gastric pH for absorption for administration instructions, including atazanavir, erlotinib, ketoconazole, itraconazole, ledipasvir/sofosbuvir, nilotinib, and rilpivirine. |
| Rilpivirine | drug interactions (prescription label) | See the prescribing information for other drugs dependent on gastric pH for absorption for administration instructions, including atazanavir, erlotinib, ketoconazole, itraconazole, ledipasvir/sofosbuvir, nilotinib, and rilpivirine. |
| Tizanidine | drug interactions (prescription label) | Potential for substantial increases in blood concentrations of tizanidine resulting in hypotension, bradycardia or excessive drowsiness; avoid concomitant use, if possible. |
Other labels that name famotidine
Source: FDA drug label (Pepcid AC Original Strength), Kenvue Brands LLC, effective February 6, 2026 (SPL set 54f4086f-e443-4e7e-8c7e-94e152e1c256), via openFDA; the full label on DailyMed
What do FAERS reports show for famotidine?
The FDA Adverse Event Reporting System holds 118,838 reports that list famotidine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 10,876 are coded as a death and 37,935 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 famotidine?
20 other medicines are given the same way (oral) and in the same FDA class as famotidine 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 |
|---|---|---|---|---|
| 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 |
| 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 |
| Lansoprazole | Acid reflux and ulcers | 59 labelers | $0.106 per capsule 30 mg capsule | No current entry |
Every medicine labeled for the same conditions as famotidine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does famotidine compare with medicines for the same use?
12 side-by-side pages set famotidine beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to famotidine
- 20 medicines for the same use
- Other H2 blockers
- the pharmacologic class, with prices and generics
- Famotidine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other