Vigabatrin
- Product NDC
- 69238-1425
- 11-digit product format
- 692381425
- Labeler code
- 69238
- Product ID
- 69238-1425_cb7e94d1-fc6e-4b9e-a58d-575d7a8a06a8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Vigabatrin
- Dosage form
- FOR SOLUTION
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals NY LLC
- Application
- ANDA210155
- Marketing category
- ANDA
- Marketing start
- 2018-03-19
- 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
- Vigabatrin
- 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 | 250820 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69238-1425-5 | Vigabatrin | 50 in 1 CARTON | FOR SOLUTION | 50 | | 18 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69238-1425 | VIGABATRIN FOR SOLUTION [AMNEAL PHARMACEUTICALS NY LLC] | 18 | Current NDC, Legacy NDC, 1 package rows | 20231231_5b8fb137-848b-45fd-9107-a6db5a675360.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 |
|---|
| 69238-1425-5 | 69238142505 | 50 FOR SOLUTION in 1 CARTON (69238-1425-5) | 50 for solution | 2018-03-19 | 0000-00-00 | No | No | Current |