Azacitidine

Product NDC
16714-578
11-digit product format
167140578
Labeler code
16714
Product ID
16714-578_ee4ad9f3-8ded-53f0-e053-2995a90ae065
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azacitidine
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
NorthStar RxLLC
Application
ANDA207475
Marketing category
ANDA
Marketing start
2022-11-18
Marketing end
0000-00-00
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
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
16714-578-01EA - Each16714-578220ea6c4-4e99-4b28-87eb-5467b82cd49e12022-12-07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16714-578-01167140578011 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (16714-578-01) 2019-01-090000-00-00NoNoCurrent