FDA.reportPublic FDA data

NELARABINE

Product NDC
72205-154
11-digit product format
722050154
Labeler code
72205
Product ID
72205-154_d556a9e7-310b-41dc-99f8-a281fe7da3fe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NELARABINE
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA216948
Marketing category
ANDA
Marketing start
2024-09-13
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
72205-154-01NELARABINE1 in 1 CARTONINJECTION11
72205-154-01NELARABINE50 mL in 1 VIALINJECTION501
72205-154-04NELARABINE50 mL in 1 VIALINJECTION501
72205-154-04NELARABINE6 in 1 CARTONINJECTION61

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-154-01ML - Milliliter72205-154b0e58d32-0411-4298-8229-9320b7f2129a12024-11-05
72205-154-04ML - Milliliter72205-15437f9cc94-2e7f-4ff0-a855-6488e6a1e2f912024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-154NELARABINE INJECTION [NOVADOZ PHARMACEUTICALS LLC]1Current NDC, 4 package rows20241030_d556a9e7-310b-41dc-99f8-a281fe7da3fe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
603566nelarabine 250 MG in 50 ML InjectionPSNd556a9e7-310b-41dc-99f8-a281fe7da3fe1
60356650 ML nelarabine 5 MG/ML InjectionSCDd556a9e7-310b-41dc-99f8-a281fe7da3fe1
603566nelarabine 250 MG per 50 ML InjectionSYd556a9e7-310b-41dc-99f8-a281fe7da3fe1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72205-154-01722050154011 VIAL in 1 CARTON (72205-154-01) / 50 mL in 1 VIAL1 vial2024-10-22NoNoCurrent
72205-154-04722050154046 VIAL in 1 CARTON (72205-154-04) / 50 mL in 1 VIAL6 vial2024-10-22NoNoCurrent