GEMCITABINE HYDROCHLORIDE
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, for intravenous useInitial U.S. Approval: 1996
Approved
Approval ID
b4e58ed9-edb8-4337-ad0d-29e075e66f1d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 14, 2020
Manufacturers
FDA
Cipla USA Inc.
DUNS: 078719707
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
GEMCITABINE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69097-314
Application NumberANDA078759
Product Classification
M
Marketing Category
C73584
G
Generic Name
GEMCITABINE HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 14, 2020
FDA Product Classification
INGREDIENTS (5)
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
GEMCITABINE HYDROCHLORIDEActive
Quantity: 1 g in 25 mL
Code: U347PV74IL
Classification: ACTIM
MANNITOLInactive
Quantity: 1 g in 25 mL
Code: 3OWL53L36A
Classification: IACT
SODIUM ACETATEInactive
Quantity: 62.5 g in 25 mL
Code: 4550K0SC9B
Classification: IACT
GEMCITABINE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69097-313
Application NumberANDA078759
Product Classification
M
Marketing Category
C73584
G
Generic Name
GEMCITABINE HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 14, 2020
FDA Product Classification
INGREDIENTS (4)
MANNITOLInactive
Quantity: 200 mg in 5 mL
Code: 3OWL53L36A
Classification: IACT
GEMCITABINE HYDROCHLORIDEActive
Quantity: 200 mg in 5 mL
Code: U347PV74IL
Classification: ACTIM
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT