Vyalev
- Product NDC
- 0074-0501
- 11-digit product format
- 000740501
- Labeler code
- 0074
- Product ID
- 0074-0501_1f0fe652-c027-4b61-9ba4-78548dd48e89
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- foscarbidopa/foslevodopa
- Dosage form
- INJECTION
- Route
- SUBCUTANEOUS
- Labeler
- AbbVie Inc.
- Application
- NDA216962
- Marketing category
- NDA
- Marketing start
- 2022-04-12
- Substance
- FOSCARBIDOPA; FOSLEVODOPA
- Active strength
- 12; 240 mg/mL; mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Vyalev
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FOSCARBIDOPA | 12 mg/mL |
| FOSLEVODOPA | 240 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5NT8HCA4OO, 37NQZ0J76I |
| Rxcui | 2695782, 2695789 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0074-0501-01 | Vyalev | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 10 | | 6 |
| 0074-0501-01 | Vyalev | 7 in 1 CARTON | INJECTION | 7 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0074-0501 | VYALEV (FOSCARBIDOPA/FOSLEVODOPA) INJECTION [ABBVIE INC.] | 4 | Current NDC, 2 package rows | 20241024_28e806e4-951c-40a9-9f0c-d0929caf054c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0074-0501-01 | 00074050101 | 7 VIAL, SINGLE-DOSE in 1 CARTON (0074-0501-01) / 10 mL in 1 VIAL, SINGLE-DOSE | 2022-04-12 | No | No | Current |