Nelarabine
These highlights do not include all the information needed to use NELARABINE INJECTION safely and effectively. See full prescribing information for NELARABINE INJECTION. NELARABINE injection, for intravenous use Initial U.S. Approval: 2005
Approved
Approval ID
8d0e1b59-bd1e-4c6e-9a95-e8143ee076bf
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 5, 2022
Manufacturers
FDA
Amneal Pharmaceuticals LLC
DUNS: 827748190
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Nelarabine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70121-1743
Application NumberANDA216346
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nelarabine
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 5, 2023
FDA Product Classification
INGREDIENTS (5)
NELARABINEActive
Quantity: 5 mg in 1 mL
Code: 60158CV180
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 4.5 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Drug Labeling Information
CONTRAINDICATIONS SECTION
LOINC: 34070-3Updated: 7/5/2022
4 CONTRAINDICATIONS
None.
Key Highlight
None. (4)
DOSAGE FORMS & STRENGTHS SECTION
LOINC: 43678-2Updated: 7/5/2022
3 DOSAGE FORMS AND STRENGTHS
Injection: 250 mg/50 mL (5 mg/mL) single-dose vial.
Key Highlight
Injection: 250 mg/50 mL (5 mg/mL) single-dose vial. (3)