Gemzar

Product NDC

0002-7501

11-digit product format

000027501

Labeler code

0002

Product ID

0002-7501_a15ac76a-1795-4c3e-be36-96b064a58d42

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Gemcitabine hydrochloride

Dosage form

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Route

INTRAVENOUS

Labeler

Eli Lilly and Company

Application

NDA020509

Marketing category

NDA

Marketing start

1996-05-15

Marketing end

2021-05-31

Substance

GEMCITABINE HYDROCHLORIDE

Active strength

200 mg/5mL

Pharmacologic classes

Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record