gemcitabine hydrochloride

Product NDC

45963-620

11-digit product format

459630620

Labeler code

45963

Product ID

45963-620_3474303a-8624-4799-838b-e2ec47556778

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

gemcitabine hydrochloride

Dosage form

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Route

INTRAVENOUS

Labeler

Actavis Pharma, Inc.

Application

ANDA079160

Marketing category

ANDA

Marketing start

2016-11-03

Marketing end

2020-03-31

Substance

GEMCITABINE HYDROCHLORIDE

Active strength

2 g/50mL

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