Dacogen

Product NDC
59148-046
11-digit product format
591480046
Labeler code
59148
Product ID
59148-046_4d5b6a30-b467-4236-bef9-4c339aab5921
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
decitabine
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Otsuka America Pharmaceutical, Inc.
Application
NDA021790
Marketing category
NDA
Marketing start
2006-05-02
Marketing end
0000-00-00
Substance
DECITABINE
Active strength
50 mg/20mL
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
59148-046-70EA - Each59148-046d2b3b917-f730-46ec-b914-a033a900449c12015-11-12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59148-046-70591480046701 VIAL in 1 CARTON (59148-046-70) > 20 mL in 1 VIAL1 vial2006-05-020000-00-00NoNoCurrent