decitabine

Product NDC
47335-361
11-digit product format
473350361
Labeler code
47335
Product ID
47335-361_ddc155a1-509c-4d7e-bab1-fa5891ef354e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
decitabine
Dosage form
KIT
Labeler
Sun Pharmaceutical Industries, Inc.
Application
NDA205582
Marketing category
NDA
Marketing start
2014-01-24
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
decitabine
Listing expiration
2026-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui636631

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
ba82e818-f876-42bf-ac8a-edb0f7670e1bProduct name120210121
871786fd-2c42-643c-2a8f-45c433540e89Product name920190709

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47335-361-41decitabine1 in 1 CARTONKIT112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47335-361-41EA - Each47335-361d27f7f04-7fd8-4d2d-b281-ece771e2ce5912014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DECITABINEACTIVE INGREDIENT776B62CQ27DECITABINE KIT [SUN PHARMA GLOBAL FZE]5
DECITABINEACTIVE MOIETY776B62CQ27DECITABINE KIT [SUN PHARMA GLOBAL FZE]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47335-361DECITABINE KIT [SUN PHARMACEUTICAL INDUSTRIES, INC.]12Current NDC, Legacy NDC, 1 package rows20200729_c155d6ba-9a16-406c-919e-65a149689ab9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636631decitabine 50 MG InjectionPSNc155d6ba-9a16-406c-919e-65a149689ab912
636631decitabine 50 MG InjectionSCDc155d6ba-9a16-406c-919e-65a149689ab912

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47335-361-41473350361411 KIT in 1 CARTON (47335-361-41) * 10 mL in 1 VIAL, SINGLE-DOSE * 10 mL in 1 VIAL (47335-362-40) 1 kit2014-01-240000-00-00NoNoCurrent