Nelarabine
- Product NDC
- 68083-233
- 11-digit product format
- 680830233
- Labeler code
- 68083
- Product ID
- 68083-233_a8747c60-a869-4e8b-ad3a-270dfc118180
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nelarabine
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA212605
- Marketing category
- ANDA
- Marketing start
- 2024-01-03
- 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 |
|---|
| 68083-233-01 | Nelarabine | 50 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 50 | | 6 |
| 68083-233-06 | Nelarabine | 6 in 1 CARTON | INJECTION | 6 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-233 | NELARABINE INJECTION [GLAND PHARMA LIMITED] | 6 | Current NDC, 2 package rows | 20250411_651bf4d2-75b0-4a60-8014-7006ffe61084.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68083-233-01 | 68083023301 | 50 mL in 1 VIAL, SINGLE-DOSE | 50 ml | | | | Historical |
| 68083-233-06 | 68083023306 | 6 VIAL, SINGLE-DOSE in 1 CARTON (68083-233-06) / 50 mL in 1 VIAL, SINGLE-DOSE (68083-233-01) | | 2024-01-03 | No | No | Current |