Azacitidine

Product NDC
43598-143
11-digit product format
435980143
Labeler code
43598
Product ID
43598-143_bf6007cd-07b7-df87-f778-610cad2941ff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azacitidine
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Dr. Reddy's Laboratories Inc.
Application
ANDA207234
Marketing category
ANDA
Marketing start
2022-04-20
Marketing end
0000-00-00
Substance
AZACITIDINE
Active strength
100 mg/50mL
Pharmacologic classes
Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-143-62EA - Each43598-14337e93c6d-bbb9-44b7-b551-a2b615823fc412022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-143AZACITIDINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [DR. REDDY'S LABORATORIES INC.]4Legacy NDC20250119_314faacb-45e7-332e-acc7-b9ff5a475b0c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-143-62435980143621 mL in 1 CARTON (43598-143-62) 1 ml2022-04-200000-00-00NoNoCurrent