FDA.reportPublic FDA data

DECITABINE

Product NDC
75834-190
11-digit product format
758340190
Labeler code
75834
Product ID
75834-190_e20c2038-e61d-4c04-8b35-f2ff37a1b8d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
decitabine
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Nivagen Pharmaceuticals, Inc.
Application
ANDA212117
Marketing category
ANDA
Marketing start
2020-12-17
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75834-190-012022-02-07C16284748780-1d6a99b39-ce87-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use DECITABINE FOR INJECTION safely and effectively. See full prescribing information for DECITABINE FOR INJECTION. DECITABINE for injection, for intravenous use Initial U.S. Approval: 2006
75834-190-012022-01-28C16284748780-1d6a99b39-ce87-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use DECITABINE FOR INJECTION safely and effectively. See full prescribing information for DECITABINE FOR INJECTION. DECITABINE for injection, for intravenous use Initial U.S. Approval: 2006

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75834-190-01DECITABINE1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,19
75834-190-01DECITABINE20 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,209

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75834-190-01EA - Each75834-190f8109904-2340-4874-aa0d-84554ac22f1712021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75834-190DECITABINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [NIVAGEN PHARMACEUTICALS, INC.]9Current NDC, Legacy NDC, 2 package rows20220303_150537a8-10ac-422d-bf33-68b1a408e566.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636631decitabine 50 MG InjectionPSN150537a8-10ac-422d-bf33-68b1a408e5669
636631decitabine 50 MG InjectionSCD150537a8-10ac-422d-bf33-68b1a408e5669

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
75834-190-01758340190011 VIAL in 1 CARTON (75834-190-01) / 20 mL in 1 VIAL1 vial2020-12-170000-00-00NoNoCurrent