Isotretinoin — ingredient monograph

Overview

Source: NDC Directory

Ingredient name

ISOTRETINOIN

Base moiety

ISOTRETINOIN

RxNorm CUI

197843

UNII

EH28UP18IF

Medication products

11

Brand names

7

Dosage forms

4

FAERS reports

49,172 · not a risk measure

Products containing this ingredient

Source: NDC Directory 11 products

Isotretinoin Powder
5 NDC
Isotretinoin M Powder
1 NDC
Isotretinoin Micronized Powder
1 NDC
Absorica isotretinoin · Capsule
Rx NDA TE AB2 6 NDC
Absorica LD isotretinoin · Capsule
Rx NDA 2 recalls 4 NDC
ACCUTANE Isotretinoin · Capsule, Gelatin Coated
Rx ANDA TE AB1 4 NDC
Amnesteem isotretinoin · Capsule
Rx ANDA TE AB1 1 recall 4 NDC
Claravis Isotretinoin · Capsule, Liquid Filled
Rx ANDA TE AB1 1 recall 4 NDC
Isotretinoin Capsule
Rx ANDA TE AB2 3 recalls 51 NDC
Isotretinoin Capsule, Liquid Filled
Rx ANDA TE AB1 1 recall 24 NDC
ZENATANE Isotretinoin · Capsule, Gelatin Coated
Rx ANDA TE AB1 8 recalls 8 NDC

Entries without a link are products listed by the FDA that carry no approval record, therapeutic equivalence rating or official labelling, so they have no detail page. Their facts are shown inline.

By dosage form

How this ingredient is presented across the catalogue.
Dosage form	Products	Examples
Capsule	4	Absorica, Absorica LD, Amnesteem, Isotretinoin
Powder	3	Isotretinoin, Isotretinoin M, Isotretinoin Micronized
CAPSULE, Gelatin Coated	2	ACCUTANE, ZENATANE
CAPSULE, Liquid Filled	2	Claravis, Isotretinoin

Sources for this page

Dataset	Agency	Used for
NDC Directory	FDA	Ingredient name, strengths, products, labelers, packages
DailyMed RxNorm mappings	NLM	RxNorm concept identifier (RxCUI)
FAERS	FDA	Adverse event report totals