Vigabatrin
- Product NDC
- 69238-1424
- 11-digit product format
- 692381424
- Labeler code
- 69238
- Product ID
- 69238-1424_96ae1401-5893-4af6-9e78-b7ec25ef42ff
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Vigabatrin
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals NY LLC
- Application
- ANDA210042
- Marketing category
- ANDA
- Marketing start
- 2022-06-27
- 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 | 199521 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69238-1424-1 | Vigabatrin | 100 in 1 BOTTLE | TABLET | 100 | | 21 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69238-1424 | VIGABATRIN TABLET [AMNEAL PHARMACEUTICALS NY LLC] | 21 | Current NDC, Legacy NDC, 1 package rows | 20241219_04fef2ec-c275-405d-91b1-99a74ee8caa2.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 |
|---|
| 69238-1424-1 | 69238142401 | 100 TABLET in 1 BOTTLE (69238-1424-1) | 100 tablet | 2022-06-27 | 0000-00-00 | No | No | Current |