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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.

ApplicationSponsorOriginal approvalListings
NDA 020325KENVUE BRANDS1995-04-284
ANDA 075805CARLSBAD2001-04-1626
ANDA 075709FRESENIUS KABI USA2001-04-161
ANDA 075718DR REDDYS LABS LTD2001-04-1614
ANDA 075511IVAX SUB TEVA PHARMS2001-04-169
ANDA 075813FRESENIUS KABI USA2001-04-163
ANDA 075302MANKIND PHARMA2001-04-163
ANDA 075486HIKMA2001-04-162
ANDA 075488HIKMA2001-04-162
ANDA 075622SAGENT2001-04-162
ANDA 075786CHARTWELL RX2001-04-162
ANDA 075400PERRIGO2005-03-1821
ANDA 077367DR REDDYS LABS LTD2006-09-2516
ANDA 077351PERRIGO R AND D2006-09-2541
ANDA 078642MYLAN LABS LTD2008-06-252
ANDA 078641MYLAN LABS LTD2008-06-252
ANDA 078916ALEMBIC PHARMS LTD2009-05-2215
ANDA 091020NAVINTA LLC2010-05-272
ANDA 090440LUPIN LTD2010-06-291
ANDA 201695NOVEL LABS INC2012-12-171
ANDA 206530AUROBINDO PHARMA LTD2015-12-2210
ANDA 206531AUROBINDO PHARMA2016-04-2640
ANDA 215043NOVITIUM PHARMA2021-04-203
ANDA 215689ASCENT PHARMS INC2021-10-152
ANDA 216030ASCENT PHARMS INC2021-11-032
ANDA 215767ANNORA PHARMA2021-11-0417
ANDA 215766ANNORA PHARMA2021-11-087
ANDA 215630VKT PHARMA2022-01-0725
ANDA 215822VKT PHARMA2022-01-2823
ANDA 216441ZYDUS PHARMS2022-06-039
ANDA 216427AMNEAL2022-08-042
ANDA 217543PHARMAZONE2023-03-087
ANDA 217655SOMERSET THERAPS LLC2023-06-162
ANDA 217137CARNEGIE2023-07-074
ANDA 217330ANNORA PHARMA2023-08-171
ANDA 217529AJANTA PHARMA LTD2023-09-181
ANDA 217669CONTRACT PHARMACAL2023-12-208
ANDA 218181RISING2023-12-222
ANDA 217400MSN2024-08-069
NDA 219935SAGENT2025-07-162

Showing 40 of 50 applications.

Official labeling on DailyMed

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.