AXTLE
- Product NDC
- 83831-131
- 11-digit product format
- 838310131
- Labeler code
- 83831
- Product ID
- 83831-131_6e125601-ebbb-4fe6-9d9e-80d093b12532
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- pemetrexed
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Avyxa Pharma, LLC
- Application
- NDA210661
- Marketing category
- NDA
- Marketing start
- 2025-01-01
- Substance
- PEMETREXED
- Active strength
- 100 mg/4mL
- Pharmacologic classes
- Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- AXTLE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PEMETREXED | 100 mg/4mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 04Q9AIZ7NO |
| Rxcui | 1728072, 1728077, 2699339, 2699341 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 83831-131-01 | AXTLE | 4 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 4 | | 9 |
| 83831-131-01 | AXTLE | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 83831-131 | AXTLE (PEMETREXED) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AVYXA PHARMA, LLC] | 2 | Current NDC, 2 package rows | 20250108_9582c46c-d8b0-44b7-a2ee-9c86f5e9b7b1.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 |
|---|
| 83831-131-01 | 83831013101 | 1 VIAL in 1 CARTON (83831-131-01) / 4 mL in 1 VIAL | 1 vial | 2025-01-01 | No | No | Current |