Gemcitabine hydrochloride

Product NDC

23155-213

11-digit product format

231550213

Labeler code

23155

Product ID

23155-213_9d200a92-19d2-4018-99b5-479d101b19f6

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

No

Listing certified through

2020-12-31

Current FDA listing

Historical FDA.report record