Vigabatrin
- Product NDC
- 0591-3851
- 11-digit product format
- 005913851
- Labeler code
- 0591
- Product ID
- 0591-3851_c29a7450-ee68-466a-a33f-bf5065da1593
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Vigabatrin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA209822
- Marketing category
- ANDA
- Marketing start
- 2019-02-06
- 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 |
|---|
| 0591-3851-01 | Vigabatrin | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 13 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0591-3851 | VIGABATRIN TABLET, FILM COATED [ACTAVIS PHARMA, INC.] | 13 | Current NDC, Legacy NDC, 1 package rows | 20250507_8dc7bd15-2636-4d58-b651-dd117ca43dbd.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0591-3851-01 | 00591385101 | 100 TABLET, FILM COATED in 1 BOTTLE (0591-3851-01) | 2019-02-06 | 0000-00-00 | No | No | Current |