Gemcitabine
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 use Initial U.S. Approval: 1996
Approved
Approval ID
70558689-02e9-4466-9fc6-6c684b2ffbf3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 28, 2021
Manufacturers
FDA
Hikma Pharmaceuticals USA Inc.
DUNS: 001230762
Products 2
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 Code0143-9395
Application NumberANDA206617
Product Classification
M
Marketing Category
C73584
G
Generic Name
Gemcitabine
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 28, 2021
FDA Product Classification
INGREDIENTS (5)
MannitolInactive
Quantity: 1 g in 1 1
Code: 3OWL53L36A
Classification: IACT
GEMCITABINEActive
Quantity: 1 g in 1 1
Code: B76N6SBZ8R
Classification: ACTIB
Sodium acetateInactive
Quantity: 62.5 mg in 1 1
Code: 4550K0SC9B
Classification: IACT
Sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
Hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
Gemcitabine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0143-9394
Application NumberANDA206617
Product Classification
M
Marketing Category
C73584
G
Generic Name
Gemcitabine
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 28, 2021
FDA Product Classification
INGREDIENTS (5)
MannitolInactive
Quantity: 200 mg in 1 1
Code: 3OWL53L36A
Classification: IACT
GEMCITABINEActive
Quantity: 200 mg in 1 1
Code: B76N6SBZ8R
Classification: ACTIB
Sodium acetateInactive
Quantity: 12.5 mg in 1 1
Code: 4550K0SC9B
Classification: IACT
Sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
Hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT