Decitabine

Product NDC
69539-115
11-digit product format
695390115
Labeler code
69539
Product ID
69539-115_57209c15-d635-40bf-9d16-c664ddfc49a4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Decitabine
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
MSN LABORATORIES PRIVATE LIMITED
Application
ANDA212265
Marketing category
ANDA
Marketing start
2019-08-28
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
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69539-115DECITABINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MSN LABORATORIES PRIVATE LIMITED]6Legacy NDC20200906_a3c1551a-41aa-4508-9d88-0210b2d4df78.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69539-115-01695390115011 VIAL, SINGLE-USE in 1 CARTON (69539-115-01) > 20 mL in 1 VIAL, SINGLE-USE2019-08-280000-00-00NoNoCurrent