FDA.reportPublic FDA data

GEMCITABINE HYDROCHLORIDE

Substance profile for UNII U347PV74IL, enriched with FDA NDC listings, DailyMed labels, legacy aliases, and open chemistry identifiers.

Chemical structure for GEMCITABINE HYDROCHLORIDE
Structure render from NCI/CADD chemical resolver

Substance Identity#

UNII
U347PV74IL
Preferred term
GEMCITABINE HYDROCHLORIDE
Registry number
122111-03-9
Ingredient type
INGREDIENT SUBSTANCE
Molecular formula
C9H11F2N3O4.ClH
Chemical structure for GEMCITABINE HYDROCHLORIDE
Structure render from NCI/CADD chemical resolver

Chemical And Database Identifiers#

InChIKey
OKKDEIYWILRZIA-OSZBKLCCSA-N
SMILES
Cl.NC1=NC(=O)N(C=C1)[C@@H]2O[C@H](CO)[C@@H](O)C2(F)F
RxCUI
236234
PubChem
0
NCIt
C961
INN ID
0

Open Chemistry Sources#

Source, Identifier, Link table
SourceIdentifierLink
PubChem InChIKey SearchOKKDEIYWILRZIA-OSZBKLCCSA-Npubchem.ncbi.nlm.nih.gov/#query=OKKDEIYWILRZIA-OSZBKLCCSA-N
RxNorm236234mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=236234
NCI ThesaurusC961ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C961
FDA Substance Registration SystemU347PV74ILprecision.fda.gov/uniisearch/srs/unii/U347PV74IL

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