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-Nhttps://pubchem.ncbi.nlm.nih.gov/#query=OKKDEIYWILRZIA-OSZBKLCCSA-N
RxNorm236234https://mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=236234
NCI ThesaurusC961https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C961
FDA Substance Registration SystemU347PV74ILhttps://precision.fda.gov/uniisearch/srs/unii/U347PV74IL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
gemcitabine hydrochlorideACTIVE INGREDIENTU347PV74ILThese 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
Gemcitabine hydrochlorideACTIVE INGREDIENTU347PV74ILGEMZAR (GEMCITABINE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ELI LILLY AND COMPANY ]18
GEMCITABINE HYDROCHLORIDEACTIVE INGREDIENTU347PV74ILGEMCITABINE (GEMCITABINE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]16
GEMCITABINE HYDROCHLORIDEACTIVE INGREDIENTU347PV74ILGEMCITABINE (GEMCITABINE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]16
GEMCITABINE HYDROCHLORIDEACTIVE INGREDIENTU347PV74ILGEMCITABINE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACTAVIS PHARMA, INC.]16
GEMCITABINE HYDROCHLORIDEACTIVE INGREDIENTU347PV74ILGEMCITABINE (GEMCITABINE HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.]13
GEMCITABINE HYDROCHLORIDEACTIVE INGREDIENTU347PV74ILGEMCITABINE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HERITAGE PHARMACEUTICALS INC.]11
GEMCITABINE HYDROCHLORIDEACTIVE INGREDIENTU347PV74ILGEMCITABINE HYDROCHLORIDE (GEMCITABINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [APP PHARMACEUTICALS, LLC]10
gemcitabine hydrochlorideACTIVE INGREDIENTU347PV74ILGEMCITABINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [DR. REDDY'S LABORATORIES LIMITED ]10
gemcitabine hydrochlorideACTIVE INGREDIENTU347PV74ILGEMCITABINE (GEMCITABINE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SAGENT PHARMACEUTICALS]7
GEMCITABINE HYDROCHLORIDEACTIVE INGREDIENTU347PV74ILGEMCITABINE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [WATSON LABORATORIES, INC.]6
GEMCITABINE HYDROCHLORIDEACTIVE INGREDIENTU347PV74ILGEMCITABINE (GEMCITABINE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SUN PHARMA GLOBAL FZE]5
GEMCITABINE HYDROCHLORIDEACTIVE INGREDIENTU347PV74ILGEMCITABINE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACCORD HEALTHCARE INC.]5
gemcitabine hydrochlorideACTIVE INGREDIENTU347PV74ILGEMCITABINE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HAMELN RDS GMBH]3
gemcitabine hydrochlorideACTIVE INGREDIENTU347PV74ILGEMCITABINE (GEMCITABINE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SAGENT PHARMACEUTICALS]2
GEMCITABINE HYDROCHLORIDEACTIVE INGREDIENTU347PV74ILGEMCITABINE (GEMCITABINE HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.]2
GEMCITABINE HYDROCHLORIDEACTIVE INGREDIENTU347PV74ILGEMCITABINE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HERITAGE PHARMACEUTICALS INC.]2
GEMCITABINE HYDROCHLORIDEACTIVE INGREDIENTU347PV74ILGEMCITABINE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC ]2
GEMCITABINE HYDROCHLORIDEACTIVE INGREDIENTU347PV74ILGEMCITABINE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HERITAGE PHARMACEUTICALS INC.]1
GEMCITABINE HYDROCHLORIDEACTIVE INGREDIENTU347PV74ILGEMCITABINE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PFIZER LABORATORIES DIV PFIZER INC.]1