FDA.reportPublic FDA data

Nelarabine

Product NDC
25021-259
11-digit product format
250210259
Labeler code
25021
Product ID
25021-259_c956537f-71c0-44bc-a2e2-ab2adaa4f756
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nelarabine
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA212605
Marketing category
ANDA
Marketing start
2024-08-01
Substance
NELARABINE
Active strength
5 mg/mL
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
Nelarabine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NELARABINE5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii60158CV180
Rxcui603566

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
68e3b4d6-92e5-2b85-ee38-af06171b640cProduct name620250331

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
25021-259-50Nelarabine1 in 1 CARTONINJECTION, SOLUTION11
25021-259-50Nelarabine50 mL in 1 VIALINJECTION, SOLUTION501
25021-259-51Nelarabine6 in 1 CARTONINJECTION, SOLUTION61
25021-259-51Nelarabine50 mL in 1 VIALINJECTION, SOLUTION501

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-259-50ML - Milliliter25021-25966ff4ff1-6bdb-4767-a796-f4d819bd09cd12024-09-09
25021-259-51ML - Milliliter25021-2591ee17ff5-c119-452d-9f88-5a2a32e51aeb12024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-259NELARABINE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]1Current NDC, 4 package rows20240802_f60da70f-2f9e-421d-a277-95b1edb57a71.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
603566nelarabine 250 MG in 50 ML InjectionPSNf60da70f-2f9e-421d-a277-95b1edb57a711
60356650 ML nelarabine 5 MG/ML InjectionSCDf60da70f-2f9e-421d-a277-95b1edb57a711
603566nelarabine 250 MG per 50 ML InjectionSYf60da70f-2f9e-421d-a277-95b1edb57a711

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
25021-259-50250210259501 VIAL in 1 CARTON (25021-259-50) / 50 mL in 1 VIAL1 vial2024-08-01NoNoHistorical
25021-259-51250210259516 VIAL in 1 CARTON (25021-259-51) / 50 mL in 1 VIAL6 vial2024-08-01NoNoHistorical