decitabine

Product NDC
68180-738
11-digit product format
681800738
Labeler code
68180
Product ID
68180-738_f7db1754-5eb9-453e-b247-470517492676
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
decitabine
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA210756
Marketing category
ANDA
Marketing start
2019-12-06
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 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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68180-738-01decitabine1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,16
68180-738-01decitabine20 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,206

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-738DECITABINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [LUPIN PHARMACEUTICALS, INC.]6Legacy NDC, 2 package rows20231215_79d5d5e3-f782-44e9-b422-664d9371647e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636631decitabine 50 MG InjectionPSN79d5d5e3-f782-44e9-b422-664d9371647e6
636631decitabine 50 MG InjectionSCD79d5d5e3-f782-44e9-b422-664d9371647e6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68180-738-01681800738011 VIAL in 1 CARTON (68180-738-01) > 20 mL in 1 VIAL1 vial2019-12-060000-00-00NoNoCurrent