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NDC 67386-0111-01 SABRIL 500 mg/1 Details
SABRIL 500 mg/1
SABRIL is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Lundbeck Pharmaceuticals LLC. The primary component is VIGABATRIN.
MedlinePlus Drug Summary
Vigabatrin tablets are used in combination with other medications to control certain types of seizures in adults and children 10 years of age or older whose seizures were not controlled by several other medications. Vigabatrin powder is used to control infantile spasms (a type of seizure that babies and children can have) in babies 1 month to 2 years of age. Vigabatrin is in a class of medications called anticonvulsants. It works by decreasing abnormal electrical activity in the brain.
Related Packages: 67386-0111-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Vigabatrin
Product Information
| NDC | 67386-0111 |
|---|---|
| Product ID | 67386-111_90b0adfa-b718-4197-a437-f0f2994539d7 |
| Associated GPIs | 72170085000320 |
| GCN Sequence Number | 017870 |
| GCN Sequence Number Description | vigabatrin TABLET 500 MG ORAL |
| HIC3 | H4B |
| HIC3 Description | ANTICONVULSANTS |
| GCN | 64315 |
| HICL Sequence Number | 007377 |
| HICL Sequence Number Description | VIGABATRIN |
| Brand/Generic | Brand |
| Proprietary Name | SABRIL |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | vigabatrin |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 500 |
| Active Ingredient Units | mg/1 |
| Substance Name | VIGABATRIN |
| Labeler Name | Lundbeck Pharmaceuticals LLC |
| Pharmaceutical Class | Anti-epileptic Agent [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA020427 |
| Listing Certified Through | 2025-12-31 |
Package
NDC 67386-0111-01 (67386011101)
| NDC Package Code | 67386-111-01 |
|---|---|
| Billing NDC | 67386011101 |
| Package | 100 TABLET, FILM COATED in 1 BOTTLE (67386-111-01) |
| Marketing Start Date | 2009-08-21 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |