FDA.reportPublic FDA data

ISOTRETINOIN

Substance profile for UNII EH28UP18IF, enriched with FDA NDC listings, DailyMed labels, legacy aliases, and open chemistry identifiers.

Chemical structure for ISOTRETINOIN
Structure render from PubChem CID 5282379

Substance Identity#

UNII
EH28UP18IF
Preferred term
ISOTRETINOIN
Registry number
4759-48-2
EC number
225-296-0
Ingredient type
INGREDIENT SUBSTANCE
Molecular formula
C20H28O2
Chemical structure for ISOTRETINOIN
Structure render from PubChem CID 5282379

Chemical And Database Identifiers#

InChIKey
SHGAZHPCJJPHSC-XFYACQKRSA-N
SMILES
CC(\C=C\C1=C(C)CCCC1(C)C)=C/C=C/C(C)=C\C(O)=O
RxCUI
6064
PubChem
5282379
NCIt
C603
INN ID
4617

Open Chemistry Sources#

Source, Identifier, Link table
SourceIdentifierLink
PubChem Compound5282379pubchem.ncbi.nlm.nih.gov/compound/5282379
PubChem InChIKey SearchSHGAZHPCJJPHSC-XFYACQKRSA-Npubchem.ncbi.nlm.nih.gov/#query=SHGAZHPCJJPHSC-XFYACQKRSA-N
RxNorm6064mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=6064
NCI ThesaurusC603ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C603
FDA Substance Registration SystemEH28UP18IFprecision.fda.gov/uniisearch/srs/unii/EH28UP18IF
European Community number225-296-0commonchemistry.cas.org/results?q=225-296-0

DailyMed Socrata Ingredients#

Type, DailyMed label, SPL version table
TypeDailyMed labelSPL version
ACTIVE MOIETYIsotretinoin Capsules USP1
ACTIVE INGREDIENTIsotretinoin Capsules USP1
ACTIVE INGREDIENTCLARAVIS™ (isotretinoin capsules USP)4
ACTIVE MOIETYCLARAVIS™ (isotretinoin capsules USP)4
ACTIVE MOIETYMyorisan TM (isotretinoin capsules, USP) 10 mg, 20 mg, 40 mg2
ACTIVE INGREDIENTMyorisan TM (isotretinoin capsules, USP) 10 mg, 20 mg, 40 mg2
ACTIVE MOIETY0018861f-1b9b-431b-84ee-9d34aab615c35
ACTIVE INGREDIENT0018861f-1b9b-431b-84ee-9d34aab615c35
ACTIVE MOIETYSOTRET ® ISOTRETINOIN CAPSULES1
ACTIVE INGREDIENTSOTRET ® ISOTRETINOIN CAPSULES1
ACTIVE INGREDIENTZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED]11
ACTIVE MOIETYZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED]11
ACTIVE INGREDIENTMYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED]9
ACTIVE MOIETYMYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED]9
ACTIVE INGREDIENTCLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.]8
ACTIVE MOIETYCLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.]8
ACTIVE MOIETYAMNESTEEM (ISOTRETINOIN) CAPSULE [MYLAN PHARMACEUTICALS INC.]7
ACTIVE INGREDIENTAMNESTEEM (ISOTRETINOIN) CAPSULE [MYLAN PHARMACEUTICALS INC.]7
ACTIVE MOIETYABSORICA (ISOTRETINOIN) CAPSULE [RANBAXY LABORATORIES INC.]4
ACTIVE INGREDIENTABSORICA (ISOTRETINOIN) CAPSULE [RANBAXY LABORATORIES INC.]4