SABRIL
- Product NDC
- 67386-211
- 11-digit product format
- 673860211
- Labeler code
- 67386
- Product ID
- 67386-211_d2901195-e325-4ca5-8453-b020a77ba6aa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- vigabatrin
- Dosage form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Labeler
- Lundbeck Pharmaceuticals LLC
- Application
- NDA022006
- Marketing category
- NDA
- Marketing start
- 2009-08-21
- 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
- SABRIL
- 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, 860898 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67386-211-65 | SABRIL | 50 in 1 CARTON | POWDER, FOR SOLUTION | 50 | | 46 |
| 67386-211-65 | SABRIL | 10 mL in 1 PACKET | POWDER, FOR SOLUTION | 10 | | 46 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67386-211 | SABRIL (VIGABATRIN) POWDER, FOR SOLUTION [LUNDBECK PHARMACEUTICALS LLC] | 42 | Current NDC, Legacy NDC, 2 package rows | 20241222_a88ac1b4-e2c9-45c0-b321-4785902172e3.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 |
|---|
| 67386-211-65 | 67386021165 | 50 PACKET in 1 CARTON (67386-211-65) / 10 mL in 1 PACKET | 50 packet | 2009-08-21 | 0000-00-00 | No | No | Current |