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Active ingredient

Isotretinoin

97 finished FDA listings contain Isotretinoin as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
ISOTRETINOIN
Dosage forms
Capsule, Capsule, Gelatin Coated, Capsule, Liquid Filled
Routes
Oral
Manufacturers / labelers
14
Strengths listed
10 mg/1 · 16 mg/1 · 20 mg/1 · 24 mg/1 · 25 mg/1 · 30 mg/1 · 32 mg/1 · 35 mg/1 · 40 mg/1 · 8 mg/1
Brand names in FDA listings
Absorica, Absorica Ld, Accutane, Amnesteem, Claravis, Zenatane

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 6064

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 075945MYLAN PHARMS INC2002-11-084
ANDA 076356TEVA PHARMS USA2003-04-111
ANDA 076135TEVA PHARMS USA2003-04-113
ANDA 076485UPSHER SMITH LABS2012-01-198
NDA 021951SUN PHARM INDS INC2012-05-2512
ANDA 202099DR REDDYS LABS LTD2013-03-2512
ANDA 207792AMNEAL PHARMS NY2017-09-294
NDA 211913SUN PHARM2019-11-054
ANDA 205063ACTAVIS LABS FL2021-03-316
ANDA 213571UPSHER SMITH LABS2021-04-122
ANDA 212333UPSHER SMITH LABS2021-09-216
ANDA 211568ZYDUS PHARMS2023-08-298
ANDA 218194AUROBINDO PHARMA2024-01-296
ANDA 216633ZYDUS PHARMS2025-05-2212
ANDA 216097AMNEAL PHARMS NY2025-10-076
ANDA 220336AUROBINDO PHARMA LTD2026-09-103

Official labeling on DailyMed

Showing the 12 most recent of 21 labels.

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