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 Compound60750pubchem.ncbi.nlm.nih.gov/compound/60750
PubChem InChIKey SearchSDUQYLNIPVEERB-QPPQHZFASA-Npubchem.ncbi.nlm.nih.gov/#query=SDUQYLNIPVEERB-QPPQHZFASA-N
RxNorm12574mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=12574
NCI ThesaurusC66876ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C66876
FDA Substance Registration SystemB76N6SBZ8Rprecision.fda.gov/uniisearch/srs/unii/B76N6SBZ8R

DailyMed Socrata Ingredients#

DailyMed label, SPL version table
DailyMed labelSPL version
These 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
GEMZAR (GEMCITABINE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ELI LILLY AND COMPANY ]18
GEMCITABINE (GEMCITABINE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]16
GEMCITABINE (GEMCITABINE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]16
GEMCITABINE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACTAVIS PHARMA, INC.]16
GEMCITABINE (GEMCITABINE HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.]13
GEMCITABINE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HERITAGE PHARMACEUTICALS INC.]11
GEMCITABINE HYDROCHLORIDE (GEMCITABINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [APP PHARMACEUTICALS, LLC]10
GEMCITABINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [DR. REDDY'S LABORATORIES LIMITED ]10
GEMCITABINE (GEMCITABINE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SAGENT PHARMACEUTICALS]7
GEMCITABINE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [WATSON LABORATORIES, INC.]6
GEMCITABINE (GEMCITABINE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SUN PHARMA GLOBAL FZE]5
GEMCITABINE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACCORD HEALTHCARE INC.]5
GEMCITABINE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HAMELN RDS GMBH]3
GEMCITABINE (GEMCITABINE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SAGENT PHARMACEUTICALS]2
GEMCITABINE (GEMCITABINE HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.]2
GEMCITABINE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HERITAGE PHARMACEUTICALS INC.]2
GEMCITABINE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC ]2
GEMCITABINE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HERITAGE PHARMACEUTICALS INC.]1
GEMCITABINE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PFIZER LABORATORIES DIV PFIZER INC.]1