NELARABINE
- Product NDC
- 62332-813
- 11-digit product format
- 623320813
- Labeler code
- 62332
- Product ID
- 62332-813_3869e365-aa84-42e8-a307-e84be57588f7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- nelarabine
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Alembic Pharmaceuticals Inc.
- Application
- ANDA218554
- 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 UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 60158CV180 | NELARABINE | 121032-29-9 | NELARABINE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 62332-813-50 | 62332081350 | 1 VIAL in 1 CARTON (62332-813-50) / 50 mL in 1 VIAL | 1 vial | 2024-08-01 | No | No | Historical |
| 62332-813-63 | 62332081363 | 6 VIAL in 1 CARTON (62332-813-63) / 50 mL in 1 VIAL | 6 vial | 2024-08-01 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| NELARABINE | Alembic Pharmaceuticals Inc. | Alembic Pharmaceuticals Limited | 2025-07-08 | Human Prescription Drug Label | 4 |