vigabatrin
- Product NDC
- 70710-1494
- 11-digit product format
- 707101494
- Labeler code
- 70710
- Product ID
- 70710-1494_b41c9be1-67c2-416e-ae53-5c31eafb8e10
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- vigabatrin
- Dosage form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals (USA) Inc.
- Application
- ANDA214671
- Marketing category
- ANDA
- Marketing start
- 2025-03-24
- Substance
- VIGABATRIN
- Active strength
- 500 mg/10mL
- 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/10mL |
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 |
|---|
| 70710-1494-1 | vigabatrin | 10 mL in 1 PACKET | POWDER, FOR SOLUTION | 10 | | 2 |
| 70710-1494-8 | vigabatrin | 50 in 1 CARTON | POWDER, FOR SOLUTION | 50 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70710-1494 | VIGABATRIN POWDER, FOR SOLUTION [ZYDUS PHARMACEUTICALS (USA) INC.] | 2 | Current NDC, 2 package rows | 20250325_6d3fc853-1b2d-47ad-a4f2-f11505601bc2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70710-1494-1 | 70710149401 | 10 mL in 1 PACKET | 10 ml | | | | Historical |
| 70710-1494-8 | 70710149408 | 50 PACKET in 1 CARTON (70710-1494-8) / 10 mL in 1 PACKET (70710-1494-1) | 50 packet | 2025-03-24 | No | No | Current |