Nelarabine
- Product NDC
- 70710-1839
- 11-digit product format
- 707101839
- Labeler code
- 70710
- Product ID
- 70710-1839_a144ddba-18cc-441e-942e-4170b34d4a3e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nelarabine
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA215037
- Marketing category
- ANDA
- Marketing start
- 2022-06-24
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70710-1839-1 | Nelarabine | 50 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 50 | | 5 |
| 70710-1839-1 | Nelarabine | 1 in 1 CARTON | INJECTION | 1 | | 5 |
| 70710-1839-8 | Nelarabine | 50 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 50 | | 5 |
| 70710-1839-8 | Nelarabine | 6 in 1 CARTON | INJECTION | 6 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70710-1839 | NELARABINE INJECTION [ZYDUS PHARMACEUTICALS USA INC.] | 5 | Current NDC, Legacy NDC, 4 package rows | 20250418_8cb23281-93ca-40b8-b8e0-c57dd4298322.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70710-1839-1 | 70710183901 | 1 VIAL, SINGLE-DOSE in 1 CARTON (70710-1839-1) / 50 mL in 1 VIAL, SINGLE-DOSE | 2022-06-24 | 0000-00-00 | No | No | Current |
| 70710-1839-8 | 70710183908 | 6 VIAL, SINGLE-DOSE in 1 CARTON (70710-1839-8) / 50 mL in 1 VIAL, SINGLE-DOSE | 2022-06-24 | 0000-00-00 | No | No | Current |