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Active ingredient

Ranitidine

17 finished FDA listings contain Ranitidine as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
RANITIDINE, RANITIDINE HYDROCHLORIDE
Dosage forms
Capsule, Syrup, Tablet, Tablet, Coated, Tablet, Film Coated
Routes
Oral
Manufacturers / labelers
8
Strengths listed
15 mg/ml · 150 mg/1 · 300 mg/1 · 75 mg/1
Brand names in FDA listings
Acid Reducer, Ranitidine Cool Mint

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 9143

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 075294DR REDDYS LABS LTD2000-03-281
ANDA 075742DR REDDYS LABS LTD2000-11-292
ANDA 077824AMNEAL PHARMS NY2006-10-132
ANDA 078192DR REDDYS LABS LTD2007-08-311
ANDA 077405PHARM ASSOC2007-09-212
ANDA 201745STRIDES PHARMA2012-02-291
ANDA 210243GRANULES2018-08-202
ANDA 209859AJANTA PHARMA LTD2018-09-272
ANDA 211289VKT PHARMA2019-01-314

Official labeling on DailyMed

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