VIGABATRIN
- Product NDC
- 0574-0470
- 11-digit product format
- 005740470
- Labeler code
- 0574
- Product ID
- 0574-0470_3d6b0f6d-7352-43ee-ae54-3baed45212ad
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- vigabatrin
- Dosage form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Labeler
- Padagis US LLC
- Application
- ANDA214992
- Marketing category
- ANDA
- Marketing start
- 2022-06-29
- Marketing end
- 0000-00-00
- Substance
- VIGABATRIN
- Active strength
- 500 mg/1
- 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 |
|---|
| excluded product | product | 0574-0470 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 0574-0470 | 0574-0470-50 | 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 |
|---|
| A214992-001 | VIGABATRIN | VIGABATRIN | 500MG/PACKET | FOR SOLUTION / ORAL | | | 2021-05-13 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0574-0470-50 | 00574047050 | 50 POWDER, FOR SOLUTION in 1 CARTON (0574-0470-50) | 2022-06-29 | 0000-00-00 | No | No | Current |