FDA.reportPublic FDA data

NELARABINE

Product NDC
62332-813
11-digit product format
623320813
Labeler code
62332
Product ID
62332-813_3869e365-aa84-42e8-a307-e84be57588f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nelarabine
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA218554
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
62332-813-50NELARABINE1 in 1 CARTONINJECTION14
62332-813-50NELARABINE50 mL in 1 VIALINJECTION504
62332-813-63NELARABINE50 mL in 1 VIALINJECTION504
62332-813-63NELARABINE6 in 1 CARTONINJECTION64

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-813-50ML - Milliliter62332-81357491499-6853-471f-aaf2-1af6a1e233b412024-12-10
62332-813-63ML - Milliliter62332-813e040a282-b0c6-47d7-8e78-7ef3fc250f8b12024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-813NELARABINE INJECTION [ALEMBIC PHARMACEUTICALS INC.]3Current NDC, 4 package rows20240808_a2a08758-9a9d-49a2-a498-9da109045ee9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
603566nelarabine 250 MG in 50 ML InjectionPSNa2a08758-9a9d-49a2-a498-9da109045ee94
60356650 ML nelarabine 5 MG/ML InjectionSCDa2a08758-9a9d-49a2-a498-9da109045ee94
603566nelarabine 250 MG per 50 ML InjectionSYa2a08758-9a9d-49a2-a498-9da109045ee94

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62332-813-50623320813501 VIAL in 1 CARTON (62332-813-50) / 50 mL in 1 VIAL1 vial2024-08-01NoNoHistorical
62332-813-63623320813636 VIAL in 1 CARTON (62332-813-63) / 50 mL in 1 VIAL6 vial2024-08-01NoNoHistorical