FDA.reportPublic FDA data

Nelarabine

Product NDC
70121-1743
11-digit product format
701211743
Labeler code
70121
Product ID
70121-1743_0aa120d1-67cb-4be7-8884-d716d8b2b8ab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nelarabine
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA216346
Marketing category
ANDA
Marketing start
2023-04-10
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nelarabine
Listing expiration
2027-12-31

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
70121-1743-1Nelarabine50 mL in 1 VIAL, SINGLE-DOSEINJECTION508
70121-1743-1Nelarabine1 in 1 CARTONINJECTION18
70121-1743-4Nelarabine6 in 1 CARTONINJECTION68
70121-1743-4Nelarabine50 mL in 1 VIAL, SINGLE-DOSEINJECTION508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70121-1743-1ML - Milliliter70121-17436260b967-3aeb-4791-8c77-6e56b0bb12cd12023-05-05
70121-1743-4ML - Milliliter70121-1743a6bf9473-8b2c-47ed-a192-242098ea996712023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70121-1743NELARABINE INJECTION [AMNEAL PHARMACEUTICALS LLC]3Current NDC, 4 package rows20230410_8d0e1b59-bd1e-4c6e-9a95-e8143ee076bf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
603566nelarabine 250 MG in 50 ML InjectionPSN8d0e1b59-bd1e-4c6e-9a95-e8143ee076bf8
60356650 ML nelarabine 5 MG/ML InjectionSCD8d0e1b59-bd1e-4c6e-9a95-e8143ee076bf8
603566nelarabine 250 MG per 50 ML InjectionSY8d0e1b59-bd1e-4c6e-9a95-e8143ee076bf8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70121-1743-1701211743011 VIAL, SINGLE-DOSE in 1 CARTON (70121-1743-1) / 50 mL in 1 VIAL, SINGLE-DOSE2025-11-18NoNoCurrent
70121-1743-4701211743046 VIAL, SINGLE-DOSE in 1 CARTON (70121-1743-4) / 50 mL in 1 VIAL, SINGLE-DOSE2023-04-10NoNoCurrent