VIGADRONE
- Product NDC
- 0245-6001
- 11-digit product format
- 002456001
- Labeler code
- 0245
- Product ID
- 0245-6001_2734e899-4ddc-836c-e063-6294a90a128f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Vigabatrin
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Upsher-Smith Laboratories, LLC
- Application
- ANDA214749
- Marketing category
- ANDA
- Marketing start
- 2023-06-29
- Substance
- VIGABATRIN
- Active strength
- 500 mg/1
- Pharmacologic classes
- Anti-epileptic Agent [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- VIGADRONE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| VIGABATRIN | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | GR120KRT6K |
| Rxcui | 199521, 2642353 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0245-6001-11 | VIGADRONE | 1 in 1 CARTON | TABLET | 1 | | 2 |
| 0245-6001-11 | VIGADRONE | 100 in 1 BOTTLE | TABLET | 100 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0245-6001 | VIGADRONE (VIGABATRIN) TABLET [UPSHER-SMITH LABORATORIES, LLC] | 2 | Current NDC, 2 package rows | 20241120_01f7f049-78c2-47c2-a66e-ec662ba48a98.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 |
|---|
| 0245-6001-11 | 00245600111 | 1 BOTTLE in 1 CARTON (0245-6001-11) / 100 TABLET in 1 BOTTLE | 1 bottle | 2023-06-30 | No | No | Historical |