vigabatrin
- Product NDC
- 70710-1287
- 11-digit product format
- 707101287
- Labeler code
- 70710
- Product ID
- 70710-1287_bf6190d6-d9f9-4a41-b0d8-c31664fcd71b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- vigabatrin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals (USA) Inc.
- Application
- ANDA215707
- Marketing category
- ANDA
- Marketing start
- 2022-01-20
- 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 |
|---|
| 70710-1287-1 | vigabatrin | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70710-1287 | VIGABATRIN TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] | 3 | Current NDC, Legacy NDC, 1 package rows | 20240322_6c0bf4fb-b234-4053-9163-1e8d0142d718.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 |
|---|
| 70710-1287-1 | 70710128701 | 100 TABLET, FILM COATED in 1 BOTTLE (70710-1287-1) | 2022-01-20 | 0000-00-00 | No | No | Current |