FDA.reportPublic FDA data

DECITABINE

Product NDC
68001-573
11-digit product format
680010573
Labeler code
68001
Product ID
68001-573_fc96fe77-06cc-dc04-e053-6394a90a99da
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
decitabine
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
BluePoint Laboratories
Application
ANDA210984
Marketing category
ANDA
Marketing start
2023-05-23
Substance
DECITABINE
Active strength
50 mg/1
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/1

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
68001-573-41DECITABINE1 in 1 VIALINJECTION, POWDER, LYOPHILIZED,12
68001-573-41DECITABINE1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-573-41EA - Each68001-573c9a5eb81-ea65-4683-90e1-a1785dadb97612023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-573DECITABINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BLUEPOINT LABORATORIES]2Current NDC, 2 package rows20230527_6c6ab831-6234-4803-8a01-5c51ec3b0716.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636631decitabine 50 MG InjectionPSN6c6ab831-6234-4803-8a01-5c51ec3b07162
636631decitabine 50 MG InjectionSCD6c6ab831-6234-4803-8a01-5c51ec3b07162

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68001-573-41680010573411 VIAL in 1 CARTON (68001-573-41) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL1 vial2023-05-23NoNoHistorical