FDA.reportPublic FDA data

Nelarabine

Product NDC
39822-0650
11-digit product format
398220650
Labeler code
39822
Product ID
39822-0650_298c4520-5858-7ce6-e063-6394a90a0531
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nelarabine
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
XGen Pharmaceuticals DJB, Inc.
Application
ANDA216510
Marketing category
ANDA
Marketing start
2025-02-17
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
39822-0650-1Nelarabine1 in 1 CARTONINJECTION12
39822-0650-1Nelarabine50 mL in 1 VIALINJECTION502
39822-0650-6Nelarabine6 in 1 CARTONINJECTION62
39822-0650-6Nelarabine50 mL in 1 VIALINJECTION502

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
39822-0650-1ML - Milliliter39822-065007cf0d48-5ef4-4327-b88d-37b0b3cf57ce12025-03-04
39822-0650-6ML - Milliliter39822-0650e7e2e099-49e0-43bc-a4cd-6e52e254640312025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
39822-0650NELARABINE INJECTION [XGEN PHARMACEUTICALS DJB, INC.]2Current NDC, 4 package rows20250221_a1cc1580-50d9-4b9b-a002-1fc6686a9515.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
603566nelarabine 250 MG in 50 ML InjectionPSNa1cc1580-50d9-4b9b-a002-1fc6686a95152
60356650 ML nelarabine 5 MG/ML InjectionSCDa1cc1580-50d9-4b9b-a002-1fc6686a95152
603566nelarabine 250 MG per 50 ML InjectionSYa1cc1580-50d9-4b9b-a002-1fc6686a95152

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
39822-0650-1398220650011 VIAL in 1 CARTON (39822-0650-1) / 50 mL in 1 VIAL1 vial2025-02-17NoNoCurrent
39822-0650-6398220650066 VIAL in 1 CARTON (39822-0650-6) / 50 mL in 1 VIAL6 vial2025-02-17NoNoCurrent