FDA.reportPublic FDA data

URSODIOL

Substance profile for UNII 724L30Y2QR, enriched with FDA NDC listings, DailyMed labels, legacy aliases, and open chemistry identifiers.

Chemical structure for URSODIOL
Structure render from PubChem CID 31401

Substance Identity#

UNII
724L30Y2QR
Preferred term
URSODIOL
Registry number
128-13-2
EC number
204-879-3
Ingredient type
INGREDIENT SUBSTANCE
Molecular formula
C24H40O4
Chemical structure for URSODIOL
Structure render from PubChem CID 31401

Chemical And Database Identifiers#

InChIKey
RUDATBOHQWOJDD-UZVSRGJWSA-N
SMILES
C[C@H](CCC(O)=O)[C@H]1CC[C@H]2[C@@H]3[C@@H](O)C[C@@H]4C[C@H](O)CC[C@]4(C)[C@H]3CC[C@]12C
RxCUI
11065
PubChem
31401
NCIt
C1818
INN ID
4920

Open Chemistry Sources#

Source, Identifier, Link table
SourceIdentifierLink
PubChem Compound31401pubchem.ncbi.nlm.nih.gov/compound/31401
PubChem InChIKey SearchRUDATBOHQWOJDD-UZVSRGJWSA-Npubchem.ncbi.nlm.nih.gov/#query=RUDATBOHQWOJDD-UZVSRGJWSA-N
RxNorm11065mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=11065
NCI ThesaurusC1818ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C1818
FDA Substance Registration System724L30Y2QRprecision.fda.gov/uniisearch/srs/unii/724L30Y2QR
European Community number204-879-3commonchemistry.cas.org/results?q=204-879-3

DailyMed Socrata Ingredients#

Type, DailyMed label, SPL version table
TypeDailyMed labelSPL version
ACTIVE INGREDIENTThese highlights do not include all the information needed to use ursodiol safely and effectively. See full prescribing information for ursodiol. Ursodiol Tablets, USP for oral use Initial U.S. Approval: 19972
ACTIVE MOIETYThese highlights do not include all the information needed to use ursodiol safely and effectively. See full prescribing information for ursodiol. Ursodiol Tablets, USP for oral use Initial U.S. Approval: 19972
ACTIVE MOIETYUrsodiol Capsules, USP2
ACTIVE INGREDIENTUrsodiol Capsules, USP2
ACTIVE MOIETYUrsodiol Capsules USP Revised: March 2009 Rx only 1747841
ACTIVE INGREDIENTUrsodiol Capsules USP Revised: March 2009 Rx only 1747841
ACTIVE INGREDIENTDrug Facts3
ACTIVE MOIETYDrug Facts3
ACTIVE INGREDIENTDrug Facts4
ACTIVE MOIETYDrug Facts4
ACTIVE INGREDIENTUrsodiol Capsules USP Revised: August 2008 Rx only 2000700-001
ACTIVE MOIETYUrsodiol Capsules USP Revised: August 2008 Rx only 2000700-001
ACTIVE INGREDIENTUrsodiol Capsules USP Revised: August 2008 Rx only 2000700-001
ACTIVE MOIETYUrsodiol Capsules USP Revised: August 2008 Rx only 2000700-001
ACTIVE MOIETYURSODIOL TABLET, FILM COATED [ACTAVIS PHARMA, INC.]12
ACTIVE INGREDIENTURSODIOL TABLET, FILM COATED [ACTAVIS PHARMA, INC.]12
ACTIVE INGREDIENTURSODIOL CAPSULE [EPIC PHARMA, LLC]9
ACTIVE MOIETYURSODIOL CAPSULE [EPIC PHARMA, LLC]9
ACTIVE MOIETYURSO 250 (URSODIOL) TABLET, FILM COATED URSO FORTE (URSODIOL) TABLET, FILM COATED [APTALIS PHARMA US, INC.]7
ACTIVE INGREDIENTURSO 250 (URSODIOL) TABLET, FILM COATED URSO FORTE (URSODIOL) TABLET, FILM COATED [APTALIS PHARMA US, INC.]7
ACTIVE MOIETYACTIGALL (URSODIOL) CAPSULE [ACTAVIS PHARMA, INC.]6
ACTIVE INGREDIENTACTIGALL (URSODIOL) CAPSULE [ACTAVIS PHARMA, INC.]6
ACTIVE MOIETYURSODIOL CAPSULE [ACTAVIS PHARMA, INC.]6
ACTIVE INGREDIENTURSODIOL CAPSULE [ACTAVIS PHARMA, INC.]6
ACTIVE MOIETYURSODIOL CAPSULE [LANNETT COMPANY, INC.]6
ACTIVE INGREDIENTURSODIOL CAPSULE [LANNETT COMPANY, INC.]6
ACTIVE MOIETYURSODIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA]6
ACTIVE INGREDIENTURSODIOL TABLET [GLENMARK PHARMACEUTICALS INC., USA]6
ACTIVE INGREDIENTURSO (URSODIOL) TABLET, FILM COATED [CARDINAL HEALTH]5
ACTIVE MOIETYURSO (URSODIOL) TABLET, FILM COATED [CARDINAL HEALTH]5
ACTIVE INGREDIENTURSODIOL (URSODIOL) CAPSULE [AVKARE, INC.]5
ACTIVE MOIETYURSODIOL (URSODIOL) CAPSULE [AVKARE, INC.]5
ACTIVE MOIETYURSODIOL CAPSULE [MYLAN PHARMACEUTICALS INC.]5
ACTIVE INGREDIENTURSODIOL CAPSULE [MYLAN PHARMACEUTICALS INC.]5
ACTIVE INGREDIENTURSODIOL TABLET, FILM COATED [PAR PHARMACEUTICAL COMPANIES, INC.]4
ACTIVE MOIETYURSODIOL TABLET, FILM COATED [PAR PHARMACEUTICAL COMPANIES, INC.]4
ACTIVE INGREDIENTURSODIOL CAPSULE [AMERICAN HEALTH PACKAGING]3
ACTIVE MOIETYURSODIOL CAPSULE [AMERICAN HEALTH PACKAGING]3
ACTIVE MOIETYURSODIOL (URSODIOL) CAPSULE [AVPAK]2
ACTIVE INGREDIENTURSODIOL (URSODIOL) CAPSULE [AVPAK]2
ACTIVE MOIETYURSODIOL CAPSULE [CARDINAL HEALTH]2
ACTIVE INGREDIENTURSODIOL CAPSULE [CARDINAL HEALTH]2
ACTIVE MOIETYURSODIOL CAPSULE [CARILION MATERIALS MANAGEMENT]2
ACTIVE INGREDIENTURSODIOL CAPSULE [CARILION MATERIALS MANAGEMENT]2
ACTIVE MOIETYURSODIOL CAPSULE [MAJOR PHARMACEUTICALS]2
ACTIVE INGREDIENTURSODIOL CAPSULE [MAJOR PHARMACEUTICALS]2
ACTIVE INGREDIENTURSODIOL TABLET [ACTAVIS PHARMA, INC.]2
ACTIVE MOIETYURSODIOL TABLET [ACTAVIS PHARMA, INC.]2
ACTIVE INGREDIENTURSODIOL TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
ACTIVE MOIETYURSODIOL TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
ACTIVE MOIETYURSODIOL CAPSULE [AMERICAN HEALTH PACKAGING]1
ACTIVE INGREDIENTURSODIOL CAPSULE [AMERICAN HEALTH PACKAGING]1
ACTIVE INGREDIENTURSODIOL CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
ACTIVE MOIETYURSODIOL CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
ACTIVE MOIETYURSODIOL CAPSULE [MAJOR PHARMACEUTICALS]1
ACTIVE INGREDIENTURSODIOL CAPSULE [MAJOR PHARMACEUTICALS]1
ACTIVE MOIETYURSODIOL CAPSULE [TAGI PHARMA, INC.]1
ACTIVE INGREDIENTURSODIOL CAPSULE [TAGI PHARMA, INC.]1
ACTIVE MOIETYURSODIOL TABLET, FILM COATED [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]1
ACTIVE INGREDIENTURSODIOL TABLET, FILM COATED [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]1
ACTIVE INGREDIENTURSODIOL TABLETS, 250 MG (URSODIOL) TABLET, FILM COATED URSODIOL TABLETS, 500 MG (URSODIOL) TABLET, FILM COATED [PRASCO LABORATORIES]1
ACTIVE MOIETYURSODIOL TABLETS, 250 MG (URSODIOL) TABLET, FILM COATED URSODIOL TABLETS, 500 MG (URSODIOL) TABLET, FILM COATED [PRASCO LABORATORIES]1