VIGABATRIN
- Product NDC
- 49884-358
- 11-digit product format
- 498840358
- Labeler code
- 49884
- Product ID
- 49884-358_5d250019-9b68-4240-b9ea-165c37690ecf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- vigabatrin
- Dosage form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Labeler
- Par Health USA, LLC
- Application
- ANDA208218
- Marketing category
- ANDA
- Marketing start
- 2017-04-27
- Substance
- VIGABATRIN
- Active strength
- 50 mg/mL
- Pharmacologic classes
- Anti-epileptic Agent [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- VIGABATRIN
- Listing expiration
- 2027-12-31
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 |
|---|
| 49884-358-03 | VIGABATRIN | 50 in 1 CARTON | POWDER, FOR SOLUTION | 50 | | 29 |
| 49884-358-52 | VIGABATRIN | 10 mL in 1 PACKET | POWDER, FOR SOLUTION | 10 | | 29 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 49884-358 | VIGABATRIN POWDER, FOR SOLUTION [ENDO USA, INC.] | 28 | Current NDC, Legacy NDC, 2 package rows | 20240523_e7cbc0a5-8c28-4451-9176-b608e228ba66.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 |
|---|
| 49884-358-03 | 49884035803 | 50 PACKET in 1 CARTON (49884-358-03) / 10 mL in 1 PACKET (49884-358-52) | 50 packet | 2017-04-27 | 0000-00-00 | No | No | Current |
| 49884-358-52 | 49884035852 | 10 mL in 1 PACKET | 10 ml | | | | | Historical |