FDA.reportPublic FDA data

Decitabine

Product NDC
72205-031
11-digit product format
722050031
Labeler code
72205
Product ID
72205-031_414e2f5c-5d05-41b7-9c24-fc7be0ba974e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Decitabine
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA212265
Marketing category
ANDA
Marketing start
2019-08-28
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DECITABINE50 mg/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii776B62CQ27
Rxcui636631

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
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
72205-031-01Decitabine1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,12
72205-031-01Decitabine20 mL in 1 VIAL, SINGLE-USEINJECTION, POWDER, LYOPHILIZED,202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-031-01EA - Each72205-0315a0b6b6f-7301-4cb4-8abf-1f8500cc82c212020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-031DECITABINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [NOVADOZ PHARMACEUTICALS LLC]2Current NDC, Legacy NDC, 2 package rows20210616_ae6c4580-3a3a-4c42-903a-1565d79521f8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636631decitabine 50 MG InjectionPSNc731a9f0-46ee-41c3-8f89-179cab13bdd2100
636631decitabine 50 MG InjectionSCDc731a9f0-46ee-41c3-8f89-179cab13bdd2100
636631decitabine 50 MG InjectionPSNae6c4580-3a3a-4c42-903a-1565d79521f82
636631decitabine 50 MG InjectionSCDae6c4580-3a3a-4c42-903a-1565d79521f82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72205-031-01722050031011 VIAL, SINGLE-USE in 1 CARTON (72205-031-01) / 20 mL in 1 VIAL, SINGLE-USE2019-08-280000-00-00NoNoCurrent