nelarabine
- Product NDC
- 81927-375
- 11-digit product format
- 819270375
- Labeler code
- 81927
- Product ID
- 81927-375_f21b358e-9f41-4dc3-858f-b55f9a8af715
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- nelarabine
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Shorla Oncology Inc.
- Application
- ANDA214809
- Marketing category
- ANDA
- Marketing start
- 2025-08-31
- 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| Ingredient | Strength |
|---|
| NELARABINE | 5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 60158CV180 |
| Rxcui | 603566, 2722411 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 81927-375-01 | nelarabine | 75 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 75 | | 6 |
| 81927-375-01 | nelarabine | 1 in 1 CARTON | INJECTION | 1 | | 6 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 81927-375-01 | 81927037501 | 1 VIAL, SINGLE-DOSE in 1 CARTON (81927-375-01) / 75 mL in 1 VIAL, SINGLE-DOSE | 2025-08-31 | No | No | Historical |