FDA.reportPublic FDA data

NELARABINE

Product NDC
46708-813
11-digit product format
467080813
Labeler code
46708
Product ID
46708-813_482d7978-12a5-467a-b10e-1789df5dd0f8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nelarabine
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Alembic Pharmaceuticals Limited
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46708-813-50NELARABINE50 mL in 1 VIALINJECTION502
46708-813-50NELARABINE1 in 1 CARTONINJECTION12
46708-813-63NELARABINE50 mL in 1 VIALINJECTION502
46708-813-63NELARABINE6 in 1 CARTONINJECTION62

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-813NELARABINE INJECTION [ALEMBIC PHARMACEUTICALS LIMITED]2Current NDC, 4 package rows20240808_03ad6056-0e71-4e7c-842a-a5f87649bdcd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
603566nelarabine 250 MG in 50 ML InjectionPSN03ad6056-0e71-4e7c-842a-a5f87649bdcd2
60356650 ML nelarabine 5 MG/ML InjectionSCD03ad6056-0e71-4e7c-842a-a5f87649bdcd2
603566nelarabine 250 MG per 50 ML InjectionSY03ad6056-0e71-4e7c-842a-a5f87649bdcd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
46708-813-50467080813501 VIAL in 1 CARTON (46708-813-50) / 50 mL in 1 VIAL1 vial2024-08-01NoNoCurrent
46708-813-63467080813636 VIAL in 1 CARTON (46708-813-63) / 50 mL in 1 VIAL6 vial2024-08-01NoNoCurrent