Active ingredient
Famotidine
356 finished FDA listings contain Famotidine as their only active ingredient; 75 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- FAMOTIDINE
- Dosage forms
- For Suspension, Injection, Injection, Solution, Powder, For Solution, Powder, For Suspension, Tablet, Tablet, Coated, Tablet, Film Coated
- Routes
- Intravenous, Oral
- Manufacturers / labelers
- 154
- Strengths listed
- 10 mg/1 · 10 mg/10mg · 10 mg/ml · 20 mg/1 · 20 mg/50ml · 4 mg/ml · 40 mg/1 · 40 mg/5ml
- Brand names in FDA listings
- Acid Controller, Acid Controller Original Strength, Acid Reducer, Acid Reducer Maximum Strength, Acid Reducer Original Strength, Acid Relief, Amazon Basic Care Acid Reducer, Basic Care Acid Reducer, Basic Care Heartburn Prevention, Berkley And Jensen Famotidine, Calmicid Ac Acid Reducer, Careone Acid Relief, Curist Acid Relief, Dg Health Acid Reducer, Dg Health Heartburn Prevention, Dg Health Heartburn Prevention Original Strength, Equaline Heartburn Prevention, Equate Famotidine, Foster And Thrive Acid Reducer, Good Sense Acid Reducer, Goodmeds Famotidine 20mg 500 Count, Heartburn Prevention, Heartburn Relief, Heartburn Relief Original Strength, Kirkland Signature Acid Controller, Leader Acid Reducer, Major Heartburn Relief Maximum Strength, Maximum Strength, Maximum Strength Acid Controller, Maximum Strength Acid Reducer, Maximum Strength Pepcid Ac Icy Cool Mint, Members Mark Acid Pep, Original Strength Heartburn Prevention, Pepcid, Pepcid Ac, Pepcid Ac Maximum Strength, Pepcid Ac Original Strength, Rolaids Acid Defense, Rugby Famotidine, Signature Care Acid Controller, Topcare Acid Reducer, Welmate Famotidine 10mg, Welmate Famotidine 20mg, Zantac 360, Zantac 360 2 Per Blister 6 Blisters, Zantac 360 Cool Mint, Zantac 360, Travel Basix
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 4278
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 020325 | KENVUE BRANDS | 1995-04-28 | 4 |
| ANDA 075805 | CARLSBAD | 2001-04-16 | 26 |
| ANDA 075709 | FRESENIUS KABI USA | 2001-04-16 | 1 |
| ANDA 075718 | DR REDDYS LABS LTD | 2001-04-16 | 14 |
| ANDA 075511 | IVAX SUB TEVA PHARMS | 2001-04-16 | 9 |
| ANDA 075813 | FRESENIUS KABI USA | 2001-04-16 | 3 |
| ANDA 075302 | MANKIND PHARMA | 2001-04-16 | 3 |
| ANDA 075486 | HIKMA | 2001-04-16 | 2 |
| ANDA 075488 | HIKMA | 2001-04-16 | 2 |
| ANDA 075622 | SAGENT | 2001-04-16 | 2 |
| ANDA 075786 | CHARTWELL RX | 2001-04-16 | 2 |
| ANDA 075400 | PERRIGO | 2005-03-18 | 21 |
| ANDA 077367 | DR REDDYS LABS LTD | 2006-09-25 | 16 |
| ANDA 077351 | PERRIGO R AND D | 2006-09-25 | 41 |
| ANDA 078642 | MYLAN LABS LTD | 2008-06-25 | 2 |
| ANDA 078641 | MYLAN LABS LTD | 2008-06-25 | 2 |
| ANDA 078916 | ALEMBIC PHARMS LTD | 2009-05-22 | 15 |
| ANDA 091020 | NAVINTA LLC | 2010-05-27 | 2 |
| ANDA 090440 | LUPIN LTD | 2010-06-29 | 1 |
| ANDA 201695 | NOVEL LABS INC | 2012-12-17 | 1 |
| ANDA 206530 | AUROBINDO PHARMA LTD | 2015-12-22 | 10 |
| ANDA 206531 | AUROBINDO PHARMA | 2016-04-26 | 40 |
| ANDA 215043 | NOVITIUM PHARMA | 2021-04-20 | 3 |
| ANDA 215689 | ASCENT PHARMS INC | 2021-10-15 | 2 |
| ANDA 216030 | ASCENT PHARMS INC | 2021-11-03 | 2 |
| ANDA 215767 | ANNORA PHARMA | 2021-11-04 | 17 |
| ANDA 215766 | ANNORA PHARMA | 2021-11-08 | 7 |
| ANDA 215630 | VKT PHARMA | 2022-01-07 | 25 |
| ANDA 215822 | VKT PHARMA | 2022-01-28 | 23 |
| ANDA 216441 | ZYDUS PHARMS | 2022-06-03 | 9 |
| ANDA 216427 | AMNEAL | 2022-08-04 | 2 |
| ANDA 217543 | PHARMAZONE | 2023-03-08 | 7 |
| ANDA 217655 | SOMERSET THERAPS LLC | 2023-06-16 | 2 |
| ANDA 217137 | CARNEGIE | 2023-07-07 | 4 |
| ANDA 217330 | ANNORA PHARMA | 2023-08-17 | 1 |
| ANDA 217529 | AJANTA PHARMA LTD | 2023-09-18 | 1 |
| ANDA 217669 | CONTRACT PHARMACAL | 2023-12-20 | 8 |
| ANDA 218181 | RISING | 2023-12-22 | 2 |
| ANDA 217400 | MSN | 2024-08-06 | 9 |
| NDA 219935 | SAGENT | 2025-07-16 | 2 |
Showing 40 of 50 applications.
Official labeling on DailyMed
- FAMOTIDINE TABLET, FILM COATED [REMEDYREPACK INC.] · version 3 · 2026-09-10
- ACID REDUCER (FAMOTIDINE) TABLET, FILM COATED [AMAZON.COM SERVICES LLC] · version 2 · 2026-09-10
- FAMOTIDINE TABLET, FILM COATED [AUROHEALTH LLC] · version 10 · 2026-09-07
- FAMOTIDINE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] · version 5 · 2026-09-02
- FAMOTIDINE INJECTION [MYLAN INSTITUTIONAL LLC] · version 7 · 2026-08-31
- FAMOTIDINE TABLET, FILM COATED [REMEDYREPACK INC.] · version 8 · 2026-08-31
- FAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] · version 3 · 2026-08-25
- FAMOTIDINE POWDER, FOR SUSPENSION [RISING PHARMA HOLDINGS, INC.] · version 1 · 2026-08-20
- FAMOTIDINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.] · version 21 · 2026-08-14
- FAMOTIDINE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.] · version 1 · 2026-08-14
- HEARTBURN PREVENTION (FAMOTIDINE) TABLET, FILM COATED [KROGER COMPANY] · version 11 · 2026-08-12
- ACID REDUCER (FAMOTIDINE) TABLET, FILM COATED [CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED] · version 4 · 2026-08-12
Showing the 12 most recent of 298 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.