vigabatrin
- Product NDC
- 80005-167
- 11-digit product format
- 800050167
- Labeler code
- 80005
- Product ID
- 80005-167_533a7f8e-4ac6-4688-9ea0-a90626c86ab8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- vigabatrin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Carnegie Pharmaceuticals LLC
- Application
- ANDA215519
- Marketing category
- ANDA
- Marketing start
- 2026-02-18
- Substance
- VIGABATRIN
- Active strength
- 500 mg/1
- Pharmacologic classes
- Anti-epileptic Agent [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- vigabatrin
- Listing expiration
- 2027-12-31
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 |
|---|
| 80005-167-11 | vigabatrin | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 1 |
| 80005-167-11 | vigabatrin | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 80005-167-11 | 80005016711 | 1 BOTTLE in 1 CARTON (80005-167-11) / 100 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2026-02-18 | No | No | Current |