FDA.reportPublic FDA data

GEMCITABINE

Substance profile for UNII B76N6SBZ8R, enriched with FDA NDC listings, DailyMed labels, legacy aliases, and open chemistry identifiers.

Chemical structure for GEMCITABINE
Structure render from PubChem CID 60750

Substance Identity#

UNII
B76N6SBZ8R
Preferred term
GEMCITABINE
Registry number
95058-81-4
Ingredient type
INGREDIENT SUBSTANCE
Molecular formula
C9H11F2N3O4
Chemical structure for GEMCITABINE
Structure render from PubChem CID 60750

Chemical And Database Identifiers#

InChIKey
SDUQYLNIPVEERB-QPPQHZFASA-N
SMILES
NC1=NC(=O)N(C=C1)[C@@H]2O[C@H](CO)[C@@H](O)C2(F)F
RxCUI
12574
PubChem
60750
NCIt
C66876
INN ID
6515

Open Chemistry Sources#

Source, Identifier, Link table
SourceIdentifierLink
PubChem Compound60750https://pubchem.ncbi.nlm.nih.gov/compound/60750
PubChem InChIKey SearchSDUQYLNIPVEERB-QPPQHZFASA-Nhttps://pubchem.ncbi.nlm.nih.gov/#query=SDUQYLNIPVEERB-QPPQHZFASA-N
RxNorm12574https://mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=12574
NCI ThesaurusC66876https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C66876
FDA Substance Registration SystemB76N6SBZ8Rhttps://precision.fda.gov/uniisearch/srs/unii/B76N6SBZ8R

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
gemcitabineACTIVE MOIETYB76N6SBZ8RThese highlights do not include all the information needed to use gemcitabine for injection safely and effectively. See full prescribing information for gemcitabine for injection. Gemcitabine For Injection, Powder, Lyophilized, For Solution For Intravenous Use Initial U.S. Approval: 19965
GemcitabineACTIVE MOIETYB76N6SBZ8RGEMZAR (GEMCITABINE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ELI LILLY AND COMPANY ]18
GEMCITABINEACTIVE MOIETYB76N6SBZ8RGEMCITABINE (GEMCITABINE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]16
GEMCITABINEACTIVE MOIETYB76N6SBZ8RGEMCITABINE (GEMCITABINE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]16
GEMCITABINEACTIVE MOIETYB76N6SBZ8RGEMCITABINE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACTAVIS PHARMA, INC.]16
GEMCITABINEACTIVE MOIETYB76N6SBZ8RGEMCITABINE (GEMCITABINE HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.]13
GEMCITABINEACTIVE MOIETYB76N6SBZ8RGEMCITABINE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HERITAGE PHARMACEUTICALS INC.]11
GEMCITABINEACTIVE MOIETYB76N6SBZ8RGEMCITABINE HYDROCHLORIDE (GEMCITABINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [APP PHARMACEUTICALS, LLC]10
gemcitabineACTIVE MOIETYB76N6SBZ8RGEMCITABINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [DR. REDDY'S LABORATORIES LIMITED ]10
gemcitabineACTIVE MOIETYB76N6SBZ8RGEMCITABINE (GEMCITABINE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SAGENT PHARMACEUTICALS]7
GEMCITABINEACTIVE MOIETYB76N6SBZ8RGEMCITABINE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [WATSON LABORATORIES, INC.]6
GEMCITABINEACTIVE MOIETYB76N6SBZ8RGEMCITABINE (GEMCITABINE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SUN PHARMA GLOBAL FZE]5
GEMCITABINEACTIVE MOIETYB76N6SBZ8RGEMCITABINE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACCORD HEALTHCARE INC.]5
gemcitabineACTIVE MOIETYB76N6SBZ8RGEMCITABINE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HAMELN RDS GMBH]3
gemcitabineACTIVE MOIETYB76N6SBZ8RGEMCITABINE (GEMCITABINE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SAGENT PHARMACEUTICALS]2
GEMCITABINEACTIVE MOIETYB76N6SBZ8RGEMCITABINE (GEMCITABINE HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.]2
GEMCITABINEACTIVE MOIETYB76N6SBZ8RGEMCITABINE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HERITAGE PHARMACEUTICALS INC.]2
GEMCITABINEACTIVE MOIETYB76N6SBZ8RGEMCITABINE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC ]2
GEMCITABINEACTIVE MOIETYB76N6SBZ8RGEMCITABINE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HERITAGE PHARMACEUTICALS INC.]1
GEMCITABINEACTIVE MOIETYB76N6SBZ8RGEMCITABINE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PFIZER LABORATORIES DIV PFIZER INC.]1