FDA.reportPublic FDA data

Azacitidine

Product NDC
75907-225
11-digit product format
759070225
Labeler code
75907
Product ID
75907-225_2f09b4de-29f7-c302-3402-6303a8e2cc7d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azacitidine
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Dr. Reddy's Laboratories Inc.
Application
ANDA201537
Marketing category
ANDA
Marketing start
2025-03-01
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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
0a0a0250-9871-4046-8497-d10e54e52bd8Product name120210510
5cc97977-a1c6-de11-70e0-61007eeef82dProduct name620180820
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75907-225-11Azacitidine1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,11
75907-225-11Azacitidine1 in 1 VIALINJECTION, POWDER, LYOPHILIZED,11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75907-225-11EA - Each75907-225cc7fe347-64da-426a-882d-b332692775cb12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75907-225AZACITIDINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [DR. REDDY'S LABORATORIES INC.]1Current NDC, 2 package rows20250302_060d56e7-1a24-87c1-7f40-149ecf424f7c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485246azaCITIDine 100 MG InjectionPSN060d56e7-1a24-87c1-7f40-149ecf424f7c1
485246azacitidine 100 MG InjectionSCD060d56e7-1a24-87c1-7f40-149ecf424f7c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
75907-225-11759070225111 VIAL in 1 CARTON (75907-225-11) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL1 vial2025-03-01NoNoCurrent