VIGABATRIN
- Product NDC
- 69097-964
- 11-digit product format
- 690970964
- Labeler code
- 69097
- Product ID
- 69097-964_4cdad60f-7614-47cb-8594-3c0257e55c28
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- vigabatrin
- Dosage form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Labeler
- Cipla USA, Inc.
- Application
- ANDA211592
- Marketing category
- ANDA
- Marketing start
- 2019-12-04
- Substance
- VIGABATRIN
- Active strength
- 500 mg/mL
- 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/mL |
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 |
|---|
| 69097-964-53 | VIGABATRIN | 10 mL in 1 PACKET | POWDER, FOR SOLUTION | 10 | | 4 |
| 69097-964-53 | VIGABATRIN | 50 in 1 CARTON | POWDER, FOR SOLUTION | 50 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69097-964 | VIGABATRIN POWDER, FOR SOLUTION [CIPLA USA, INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20220511_823cc915-0350-4780-85ed-cd1c338e429d.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 |
|---|
| 69097-964-53 | 69097096453 | 50 PACKET in 1 CARTON (69097-964-53) / 10 mL in 1 PACKET | 50 packet | 2019-12-04 | 0000-00-00 | No | No | Current |