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Active ingredient

Cimetidine

38 finished FDA listings contain Cimetidine as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
CIMETIDINE, CIMETIDINE HYDROCHLORIDE
Dosage forms
Solution, Tablet, Tablet, Film Coated
Routes
Oral
Manufacturers / labelers
20
Strengths listed
200 mg/1 · 300 mg/1 · 300 mg/5ml · 400 mg/1 · 800 mg/1
Brand names in FDA listings
Acid Controller, Acid Reducer, Basic Care Acid Reducer, Cimetidine 200 Acid Reducer, Equate Cimetidine, Heartburn Prevention, Heartburn Relief, Tagamet

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 2541

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
ANDA 074463TEVA1994-05-171
ANDA 074246MYLAN1994-05-177
ANDA 074151TEVA1994-05-175
ANDA 074329CHARTWELL MOLECULES1994-05-174
ANDA 074251CHARTWELL MOLECULAR1994-12-222
NDA 020238MEDTECH PRODUCTS1995-06-193
ANDA 074664PAI HOLDINGS PHARM1997-10-281
ANDA 075285L PERRIGO CO1998-10-297
ANDA 218220BIONPHARMA2024-11-074
ANDA 218997AUROBINDO PHARMA LTD2024-11-124

Official labeling on DailyMed

Showing the 12 most recent of 22 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.