Gemcitabine
These highlights do not include all the information needed to use GEMCITABINE INJECTION safely and effectively. See full prescribing information for GEMCITABINE INJECTION. GEMCITABINE injection, for intravenous use Initial U.S. Approval: 1996
Approved
Approval ID
e18ed1cb-7dd0-4001-bfda-17d1f4587fb8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 9, 2020
Manufacturers
FDA
Hospira, Inc.
DUNS: 141588017
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
GEMCITABINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0409-0182
Application NumberNDA200795
Product Classification
M
Marketing Category
C73594
G
Generic Name
GEMCITABINE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 30, 2019
FDA Product Classification
INGREDIENTS (4)
GEMCITABINE HYDROCHLORIDEActive
Quantity: 38 mg in 1 mL
Code: U347PV74IL
Classification: ACTIM
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
GEMCITABINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0409-0181
Application NumberNDA200795
Product Classification
M
Marketing Category
C73594
G
Generic Name
GEMCITABINE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 30, 2019
FDA Product Classification
INGREDIENTS (4)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
GEMCITABINE HYDROCHLORIDEActive
Quantity: 38 mg in 1 mL
Code: U347PV74IL
Classification: ACTIM
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
GEMCITABINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0409-0183
Application NumberNDA200795
Product Classification
M
Marketing Category
C73594
G
Generic Name
GEMCITABINE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 30, 2019
FDA Product Classification
INGREDIENTS (4)
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GEMCITABINE HYDROCHLORIDEActive
Quantity: 38 mg in 1 mL
Code: U347PV74IL
Classification: ACTIM
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT