Nelarabine

Product NDC
25021-259
11-digit product format
250210259
Labeler code
25021
Product ID
25021-259_c956537f-71c0-44bc-a2e2-ab2adaa4f756
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nelarabine
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA212605
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
60158CV180NELARABINE121032-29-9NELARABINE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
25021-259-50250210259501 VIAL in 1 CARTON (25021-259-50) / 50 mL in 1 VIAL1 vial2024-08-01NoNoHistorical
25021-259-51250210259516 VIAL in 1 CARTON (25021-259-51) / 50 mL in 1 VIAL6 vial2024-08-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
NelarabineSagent Pharmaceuticals2024-05-28HUMAN PRESCRIPTION DRUG LABEL1