Azacitidine

Product NDC
72572-020
11-digit product format
725720020
Labeler code
72572
Product ID
72572-020_e2e6729f-6e81-476f-af63-82c094d4f6ee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azacitidine
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Civica, Inc.
Application
ANDA212580
Marketing category
ANDA
Marketing start
2024-05-16
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Azacitidine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AZACITIDINE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiM801H13NRU
Rxcui485246

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0a0a0250-9871-4046-8497-d10e54e52bd8Product name120210510
5cc97977-a1c6-de11-70e0-61007eeef82dProduct name620180820

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72572-020-01Azacitidine1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485246azaCITIDine 100 MG InjectionPSN2d15b3ec-ed08-48c6-a400-34e55974afad3
485246azacitidine 100 MG InjectionSCD2d15b3ec-ed08-48c6-a400-34e55974afad3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72572-020-01725720020011 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (72572-020-01) 2025-09-12NoNoCurrent