Nelarabine
- Product NDC
- 70771-1685
- 11-digit product format
- 707711685
- Labeler code
- 70771
- Product ID
- 70771-1685_d96809f2-f942-4f6d-92b9-0a23ec84226d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nelarabine
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Zydus Lifesciences Limited
- Application
- ANDA215037
- Marketing category
- ANDA
- Marketing start
- 2021-11-17
- 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 |
|---|
| 70771-1685-1 | Nelarabine | 1 in 1 CARTON | INJECTION | 1 | | 2 |
| 70771-1685-1 | Nelarabine | 50 mL in 1 VIAL | INJECTION | 50 | | 2 |
| 70771-1685-8 | Nelarabine | 50 mL in 1 VIAL | INJECTION | 50 | | 2 |
| 70771-1685-8 | Nelarabine | 6 in 1 CARTON | INJECTION | 6 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70771-1685 | NELARABINE INJECTION [ZYDUS LIFESCIENCES LIMITED] | 2 | Current NDC, Legacy NDC, 4 package rows | 20221122_877b69a0-0899-455d-926e-f5a7478c31f8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70771-1685-1 | 70771168501 | 1 VIAL in 1 CARTON (70771-1685-1) / 50 mL in 1 VIAL | 1 vial | 2021-11-17 | 0000-00-00 | No | No | Current |
| 70771-1685-8 | 70771168508 | 6 VIAL in 1 CARTON (70771-1685-8) / 50 mL in 1 VIAL | 6 vial | 2021-11-17 | 0000-00-00 | No | No | Current |