AZACITIDINE

Product NDC

63759-0003

11-digit product format

637590003

Labeler code

63759

Product ID

63759-0003_aa9df125-bf25-4ac9-a339-a0e6638be29c

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

azacitidine for

Dosage form

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Route

INTRAVENOUS; SUBCUTANEOUS

Labeler

Shilpa Medicare Limited

Application

ANDA207518

Marketing category

ANDA

Marketing start

2016-12-05

Marketing end

0000-00-00

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

2019-12-31

Current FDA listing

Historical FDA.report record