FDA.reportPublic FDA data

Arranon

Product NDC
0078-0683
11-digit product format
000780683
Labeler code
0078
Product ID
0078-0683_b1a3f864-56e1-44da-b2d0-7158d0945513
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nelarabine
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Novartis Pharmaceuticals Corporation
Application
NDA021877
Marketing category
NDA
Marketing start
2016-10-05
Marketing end
2026-09-30
Substance
NELARABINE
Active strength
5 mg/mL
Pharmacologic classes
Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Arranon

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NELARABINE5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii60158CV180
Rxcui603566, 616366

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
0078-0683-06Arranon6 in 1 CARTONINJECTION610
0078-0683-06Arranon50 mL in 1 VIALINJECTION5010
0078-0683-61Arranon50 mL in 1 VIALINJECTION5010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0683-06ML - Milliliter0078-0683dd29a18d-7d73-410e-ba1b-c98f0f5e553312016-11-08
0078-0683-61ML - Milliliter0078-0683ffe8c991-8d5e-414e-8018-fa0e8c516ee112016-11-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-0683ARRANON (NELARABINE) INJECTION [NOVARTIS PHARMACEUTICALS CORPORATION]10Current NDC, Legacy NDC, 3 package rows20250322_fffa5d75-0dba-4ad7-a252-5f60fa28489a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616366ARRANON 250 MG in 50 ML InjectionPSNfffa5d75-0dba-4ad7-a252-5f60fa28489a10
603566nelarabine 250 MG in 50 ML InjectionPSNfffa5d75-0dba-4ad7-a252-5f60fa28489a10
61636650 ML nelarabine 5 MG/ML Injection [Arranon]SBDfffa5d75-0dba-4ad7-a252-5f60fa28489a10
60356650 ML nelarabine 5 MG/ML InjectionSCDfffa5d75-0dba-4ad7-a252-5f60fa28489a10
616366Arranon 250 MG per 50 ML InjectionSYfffa5d75-0dba-4ad7-a252-5f60fa28489a10
603566nelarabine 250 MG per 50 ML InjectionSYfffa5d75-0dba-4ad7-a252-5f60fa28489a10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0078-0683-06000780683066 VIAL in 1 CARTON (0078-0683-06) > 50 mL in 1 VIAL6 vial2016-10-050000-00-00NoNoCurrent
0078-0683-610007806836150 mL in 1 VIAL (0078-0683-61) 50 ml2019-08-022026-09-30NoNoCurrent