DECITABINE

Product NDC
50742-430
11-digit product format
507420430
Labeler code
50742
Product ID
50742-430_c71b018e-22c6-4c0f-a8e8-6e320822e092
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
decitabine
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Ingenus Pharmaceuticals, LLC
Application
ANDA210984
Marketing category
ANDA
Marketing start
2019-09-25
Marketing end
0000-00-00
Substance
DECITABINE
Active strength
50 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 Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
ba82e818-f876-42bf-ac8a-edb0f7670e1bProduct name120210121
871786fd-2c42-643c-2a8f-45c433540e89Product name920190709

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50742-430-01EA - Each50742-43062255550-ab6d-441e-92fb-f3d03308841612019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50742-430DECITABINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [INGENUS PHARMACEUTICALS, LLC]11Legacy NDC20241115_b3a26585-e247-4b2e-a4ce-817b3aac2ff3.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50742-430-01507420430011 VIAL in 1 CARTON (50742-430-01) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL1 vial2019-09-250000-00-00NoNoCurrent