Azacitidine

Product NDC

0591-2897

11-digit product format

005912897

Labeler code

0591

Product ID

0591-2897_a64473c7-abe3-4c13-aa77-3a4e36d26db9

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Azacitidine

Dosage form

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Route

INTRAVENOUS; SUBCUTANEOUS

Labeler

Actavis Pharma, Inc.

Application

NDA208216

Marketing category

NDA

Marketing start

2016-09-22

Marketing end

2019-04-30

Substance

AZACITIDINE

Active strength

100 mg/1

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