Gemcitabine

Product NDC

45963-636

11-digit product format

459630636

Labeler code

45963

Product ID

45963-636_88b5e42c-b288-437a-85cc-d9031db65ac9

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Gemcitabine

Dosage form

INJECTION

Route

INTRAVENOUS

Labeler

Actavis Pharma, Inc.

Application

ANDA204549

Marketing category

ANDA

Marketing start

2016-04-12

Marketing end

2020-09-30

Substance

GEMCITABINE HYDROCHLORIDE

Active strength

38 mg/mL

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