VIGABATRIN
- Product NDC
- 67877-674
- 11-digit product format
- 678770674
- Labeler code
- 67877
- Product ID
- 67877-674_e55f8225-aa06-4e46-81d2-757233b95585
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- VIGABATRIN
- Dosage form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Labeler
- Ascend Laboratories, LLC
- Application
- ANDA213375
- Marketing category
- ANDA
- Marketing start
- 2020-12-03
- Substance
- VIGABATRIN
- Active strength
- 50 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 | 50 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 |
|---|
| 67877-674-63 | VIGABATRIN | 50 in 1 CARTON | POWDER, FOR SOLUTION | 50 | | 9 |
| 67877-674-63 | VIGABATRIN | 10 mL in 1 PACKET | POWDER, FOR SOLUTION | 10 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67877-674 | VIGABATRIN POWDER, FOR SOLUTION [ASCEND LABORATORIES, LLC] | 9 | Current NDC, Legacy NDC, 2 package rows | 20230601_ee835fb6-2b2b-40c4-b6d7-0ad0e790cda8.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 |
|---|
| 67877-674-63 | 67877067463 | 50 PACKET in 1 CARTON (67877-674-63) / 10 mL in 1 PACKET | 50 packet | 2020-12-03 | 0000-00-00 | No | No | Current |