vigabatrin
- Product NDC
- 0591-3955
- 11-digit product format
- 005913955
- Labeler code
- 0591
- Product ID
- 0591-3955_bb26e312-15c4-4764-ae8b-b309c3d8d362
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- vigabatrin
- Dosage form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA209824
- Marketing category
- ANDA
- Marketing start
- 2020-05-14
- Marketing end
- 0000-00-00
- Substance
- VIGABATRIN
- Active strength
- 50 mg/mL
- Pharmacologic classes
- Anti-epileptic Agent [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|
| unfinished product | product | 0591-3955 | | UNFINISHED | Active or certified unfinished drug listing | | 2026-07-31 |
| unfinished package | package | 0591-3955 | 0591-3955-00 | UNFINISHED | Active or certified unfinished drug listing | | 2026-07-31 |
| excluded product | product | 0591-3955 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 0591-3955 | 0591-3955-50 | D | Discontinued by firm | | 2026-07-31 |
Orange Book products#
Application-product, Trade name, Ingredient table| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|
| A209824-001 | VIGABATRIN | VIGABATRIN | 500MG/PACKET | FOR SOLUTION / ORAL | | | 2018-04-23 |
Additional Listing Data#
- Finished product
- No
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| VIGABATRIN | 50 mg/mL |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0591-3955 | VIGABATRIN POWDER, FOR SOLUTION [ACTAVIS PHARMA, INC.] | 8 | Legacy NDC | 20230615_1ce1c52d-441a-4ed7-afff-568192197454.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0591-3955-00 | 00591395500 | 10 mL in 1 BOX (0591-3955-00) | 10 ml | 23-APR-18 | | | | Current |
| 0591-3955-50 | 00591395550 | 50 PACKET in 1 CARTON (0591-3955-50) > 10 mL in 1 PACKET (0591-3955-11) | 50 packet | 2020-05-14 | 0000-00-00 | No | No | Current |