FDA.reportPublic FDA data

Decitabine

Product NDC
31722-304
11-digit product format
317220304
Labeler code
31722
Product ID
31722-304_1bc57ba5-cc43-192b-e063-6394a90a0b53
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Decitabine
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA215355
Marketing category
ANDA
Marketing start
2024-05-10
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
ba82e818-f876-42bf-ac8a-edb0f7670e1bProduct name120210121
871786fd-2c42-643c-2a8f-45c433540e89Product name920190709

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-304-31Decitabine1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,11
31722-304-31Decitabine10 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-304-31EA - Each31722-304e32872e4-b4d2-454d-910a-b0848531d82d12024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-304DECITABINE (DECITABINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CAMBER PHARMACEUTICALS, INC.]1Current NDC, 2 package rows20240627_5662c353-05d0-4bd8-87e4-c92ec9ca861e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636631decitabine 50 MG InjectionPSN5662c353-05d0-4bd8-87e4-c92ec9ca861e1
636631decitabine 50 MG InjectionSCD5662c353-05d0-4bd8-87e4-c92ec9ca861e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
31722-304-31317220304311 VIAL, SINGLE-DOSE in 1 CARTON (31722-304-31) / 10 mL in 1 VIAL, SINGLE-DOSE2024-05-10NoNoCurrent