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NDC 16729-0306-10 Azacitidine 100 mg/1 Details

Azacitidine 100 mg/1

Azacitidine is a INTRAVENOUS; SUBCUTANEOUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Accord Healthcare Inc.. The primary component is AZACITIDINE.

MedlinePlus Drug Summary

Azacitidine is used to treat myelodysplastic syndrome (a group of conditions in which the bone marrow produces blood cells that are misshapen and does not produce enough healthy blood cells). Azacitidine is in a class of medications called demethylation agents. It works by helping the bone marrow to produce normal blood cells and by killing abnormal cells in the bone marrow.

Related Packages: 16729-0306-10
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Azacitidine Injection

Product Information

NDC	16729-0306
Product ID	16729-306_0e1e7f41-f749-27cf-e063-6394a90a1ae0
Associated GPIs	21300003001920
GCN Sequence Number	054660
GCN Sequence Number Description	azacitidine VIAL 100 MG INJECTION
HIC3	V1B
HIC3 Description	ANTINEOPLASTIC - ANTIMETABOLITES
GCN	22663
HICL Sequence Number	026361
HICL Sequence Number Description	AZACITIDINE
Brand/Generic	Generic
Proprietary Name	Azacitidine
Proprietary Name Suffix	n/a
Non-Proprietary Name	Azacitidine
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route	INTRAVENOUS; SUBCUTANEOUS
Active Ingredient Strength	100
Active Ingredient Units	mg/1
Substance Name	AZACITIDINE
Labeler Name	Accord Healthcare Inc.
Pharmaceutical Class	Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA207475
Listing Certified Through	2025-12-31

Package

NDC 16729-0306-10 (16729030610)

Pricing Information	N/A
NDC Package Code	16729-306-10
Billing NDC	16729030610
Package	1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (16729-306-10)
Marketing Start Date	2019-01-09
NDC Exclude Flag	N