Decitabine

Product NDC

42737-110

11-digit product format

427370110

Labeler code

42737

Product ID

42737-110_7086b718-9a0b-4f19-8267-4f5da5e6f308

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Decitabine

Dosage form

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Route

INTRAVENOUS

Labeler

Chemi Pharma LLC

Application

ANDA206033

Marketing category

ANDA

Marketing start

2019-10-31

Marketing end

0000-00-00

Substance

DECITABINE

Active strength

50 mg/20mL

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