GEMCITABINE
These highlights do not include all the information needed to use GEMCITABINE FOR INJECTION, USP safely and effectively. See full prescribing information for GEMCITABINE FOR INJECTION, USP. GEMCITABINE for injection, USP, for intravenous use Initial U.S. Approval:1996
Approved
Approval ID
c550dd16-a5e8-44be-87f2-210c15bbb513
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 4, 2020
Manufacturers
FDA
Fresenius Kabi USA, LLC
DUNS: 608775388
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 Code63323-126
Application NumberANDA090799
Product Classification
M
Marketing Category
C73584
G
Generic Name
GEMCITABINE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 17, 2019
FDA Product Classification
INGREDIENTS (5)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
GEMCITABINE HYDROCHLORIDEActive
Quantity: 2 g in 50 mL
Code: U347PV74IL
Classification: ACTIM
GEMCITABINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63323-102
Application NumberANDA090799
Product Classification
M
Marketing Category
C73584
G
Generic Name
GEMCITABINE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 17, 2019
FDA Product Classification
INGREDIENTS (5)
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
GEMCITABINE HYDROCHLORIDEActive
Quantity: 200 mg in 5 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 Code63323-125
Application NumberANDA090799
Product Classification
M
Marketing Category
C73584
G
Generic Name
GEMCITABINE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 17, 2019
FDA Product Classification
INGREDIENTS (5)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
GEMCITABINE HYDROCHLORIDEActive
Quantity: 1 g in 25 mL
Code: U347PV74IL
Classification: ACTIM