Decitabine

Product NDC
0781-3296
11-digit product format
007813296
Labeler code
0781
Product ID
0781-3296_b3b21f11-b17a-4615-88ee-342024d9fe16
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Decitabine
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Sandoz Inc
Application
ANDA212265
Marketing category
ANDA
Marketing start
2020-03-01
Marketing end
0000-00-00
Substance
DECITABINE
Active strength
50 mg/10mL
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
0781-3296-80EA - Each0781-3296cfaeb73f-8470-4196-ba25-082f76bdaa4412020-05-08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0781-3296-80007813296801 VIAL, SINGLE-DOSE in 1 CARTON (0781-3296-80) > 10 mL in 1 VIAL, SINGLE-DOSE2020-03-010000-00-00NoNoCurrent