FDA.reportPublic FDA data

Nelarabine

Product NDC
43598-142
11-digit product format
435980142
Labeler code
43598
Product ID
43598-142_8105c460-afd8-5eec-7857-c2e4e5b89fc3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nelarabine
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Dr. Reddy's Laboratories, Inc.
Application
ANDA216934
Marketing category
ANDA
Marketing start
2023-01-09
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
43598-142-06Nelarabine6 in 1 CARTONINJECTION67
43598-142-06Nelarabine50 mL in 1 VIAL, SINGLE-DOSEINJECTION507
43598-142-11Nelarabine1 in 1 CARTONINJECTION17
43598-142-11Nelarabine50 mL in 1 VIAL, SINGLE-DOSEINJECTION507

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-142-06ML - Milliliter43598-142b3de563f-b5c7-499e-9a20-e975d4844a9312023-01-09
43598-142-11ML - Milliliter43598-1429897a51a-0c40-4cf0-909d-d21bd4ba421c12023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-142NELARABINE INJECTION [DR. REDDY'S LABORATORIES, INC.]6Current NDC, Legacy NDC, 4 package rows20240727_57275b05-f40f-7298-5a5e-93594bc41437.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
603566nelarabine 250 MG in 50 ML InjectionPSN57275b05-f40f-7298-5a5e-93594bc414377
60356650 ML nelarabine 5 MG/ML InjectionSCD57275b05-f40f-7298-5a5e-93594bc414377
603566nelarabine 250 MG per 50 ML InjectionSY57275b05-f40f-7298-5a5e-93594bc414377

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43598-142-06435980142066 VIAL, SINGLE-DOSE in 1 CARTON (43598-142-06) / 50 mL in 1 VIAL, SINGLE-DOSE2023-01-090000-00-00NoNoCurrent
43598-142-11435980142111 VIAL, SINGLE-DOSE in 1 CARTON (43598-142-11) / 50 mL in 1 VIAL, SINGLE-DOSE2023-03-01NoNoHistorical