GEMCITABINE

Basic Information

Product Name

GEMCITABINE

FDA Product Code

50742-497

Regulatory Information

NDC Product Code

50742-497

Application Number

ANDA210383

Marketing Category

C73584

Effective Date

December 3, 2022

Territorial Authority

USA

FDA Title

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

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

GEMCITABINE HYDROCHLORIDE

Quantity: 38 mg in 1 mL

Code: U347PV74IL

Class Code: ACTIM

Inactive Ingredients

SODIUM HYDROXIDE

Code: 55X04QC32I

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

HYDROCHLORIC ACID

Code: QTT17582CB

Class Code: IACT

Active Moieties

Code: B76N6SBZ8R

GEMCITABINE

Basic Information

Regulatory Information

Company Information

Active Ingredients

Inactive Ingredients

SODIUM HYDROXIDE

WATER

HYDROCHLORIC ACID

Active Moieties

GEMCITABINE