Azacitidine

Product NDC
68001-504
11-digit product format
680010504
Labeler code
68001
Product ID
68001-504_c32554cb-be86-d0d7-e053-2995a90a63a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azacitidine
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
SUBCUTANEOUS
Labeler
BluePoint Laboratories
Application
ANDA207234
Marketing category
ANDA
Marketing start
2021-06-11
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
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-504-54EA - Each68001-504f034fe81-08d0-4ca5-acc8-62070046356912021-08-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68001-504-54680010504541 VIAL, SINGLE-DOSE in 1 CARTON (68001-504-54) > 50 mL in 1 VIAL, SINGLE-DOSE2021-06-110000-00-00NoNoCurrent