Azacitidine

Product NDC
51991-797
11-digit product format
519910797
Labeler code
51991
Product ID
51991-797_1ba11f6a-c960-4e56-9f71-fdc972d990db
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azacitidine
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
SUBCUTANEOUS
Labeler
Breckenridge Pharmaceutical, Inc.
Application
ANDA207234
Marketing category
ANDA
Marketing start
2017-06-23
Marketing end
2024-01-31
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
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51991-797-98EA - Each51991-79713e565f7-3c61-4d85-9586-34b428223b7d12017-10-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51991-797-98519910797981 VIAL, SINGLE-DOSE in 1 CARTON (51991-797-98) > 50 mL in 1 VIAL, SINGLE-DOSE2017-08-070000-00-00NoNoCurrent