Gemcitabine hydrochloride

Product NDC

23155-483

11-digit product format

231550483

Labeler code

23155

Product ID

23155-483_7e85d62c-003c-4dc5-9ea0-804d2f425546

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Gemcitabine hydrochloride

Dosage form

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Route

INTRAVENOUS

Labeler

Heritage Pharmaceuticals Inc.

Application

ANDA202063

Marketing category

ANDA

Marketing start

2012-10-22

Marketing end

0000-00-00

Substance

GEMCITABINE HYDROCHLORIDE

Active strength

200 mg/5mL

Pharmacologic classes

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

NDC exclude flag

E

Listing certified through

2017-12-31

Current FDA listing

Historical FDA.report record