FDA.reportPublic FDA data

Decitabine

Product NDC
71288-119
11-digit product format
712880119
Labeler code
71288
Product ID
71288-119_2e50eb33-f576-404d-8ef5-402f1d95acc0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Decitabine
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Meitheal Pharmaceuticals Inc.
Application
ANDA212959
Marketing category
ANDA
Marketing start
2021-07-02
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
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/20mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii776B62CQ27
Rxcui636631

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
71288-119-20Decitabine1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,16
71288-119-20Decitabine20 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,206
71288-119-91Decitabine20 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,201
71288-119-91Decitabine1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-119-20EA - Each71288-11965b2a159-1744-43b5-91b0-96ac6701e0c212022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-119DECITABINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC.]5Current NDC, Legacy NDC, 2 package rows20210708_a535a235-e1d2-4520-93fe-b7dd9b047784.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636631decitabine 50 MG InjectionPSNa535a235-e1d2-4520-93fe-b7dd9b0477846
636631decitabine 50 MG InjectionSCDa535a235-e1d2-4520-93fe-b7dd9b0477846
636631decitabine 50 MG InjectionPSNa3771445-1c68-4883-a014-74f8793f31361
636631decitabine 50 MG InjectionSCDa3771445-1c68-4883-a014-74f8793f31361

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71288-119-20712880119201 VIAL, SINGLE-DOSE in 1 CARTON (71288-119-20) / 20 mL in 1 VIAL, SINGLE-DOSE2021-07-020000-00-00NoNoCurrent
71288-119-91712880119911 VIAL, SINGLE-DOSE in 1 CARTON (71288-119-91) / 20 mL in 1 VIAL, SINGLE-DOSE2021-07-02NoNoHistorical