AZACITIDINE

Product NDC
72606-558
11-digit product format
726060558
Labeler code
72606
Product ID
72606-558_1542236d-9049-4a6b-8956-c53d38f8520c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
azacitidine
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
CELLTRION USA, INC.
Application
ANDA207518
Marketing category
ANDA
Marketing start
2020-01-06
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
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72606-558-012025-03-13C16284748780-12cef2736-5b13-d83d-e063-dadaa90ab31fb4bcca95-d0b0-42dd-9dbb-637ab98effcc
72606-558-012025-01-30C16284748780-12cef2736-5b13-d83d-e063-dadaa90ab31fb4bcca95-d0b0-42dd-9dbb-637ab98effcc

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72606-558-01EA - Each72606-558710a1d60-8cb6-4f8b-a774-6cde2bcdf1f612020-03-10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72606-558-01726060558011 VIAL in 1 CARTON (72606-558-01) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL1 vial2020-01-060000-00-00NoNoCurrent