VIDAZA

Product NDC
59572-102
11-digit product format
595720102
Labeler code
59572
Product ID
59572-102_8cba79e2-11fa-4eb9-87e7-827ca781fbf3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
azacitidine
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Celgene Corporation
Application
NDA050794
Marketing category
NDA
Marketing start
2004-07-05
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
VIDAZA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AZACITIDINE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiM801H13NRU
Rxcui485246, 545206

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
59572-102-01VIDAZA1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,122

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59572-102VIDAZA (AZACITIDINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CELGENE CORPORATION]22Current NDC, Legacy NDC, 1 package rows20240130_3495a71a-cc04-4776-851f-f185956f32af.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485246azaCITIDine 100 MG InjectionPSN3495a71a-cc04-4776-851f-f185956f32af22
545206Vidaza 100 MG InjectionPSN3495a71a-cc04-4776-851f-f185956f32af22
545206azacitidine 100 MG Injection [Vidaza]SBD3495a71a-cc04-4776-851f-f185956f32af22
485246azacitidine 100 MG InjectionSCD3495a71a-cc04-4776-851f-f185956f32af22
545206Vidaza 100 MG InjectionSY3495a71a-cc04-4776-851f-f185956f32af22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59572-102-01595720102011 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (59572-102-01) 2004-07-050000-00-00NoNoCurrent