Vigabatrin
- Product NDC
- 72205-093
- 11-digit product format
- 722050093
- Labeler code
- 72205
- Product ID
- 72205-093_082d818a-4f4e-4675-98c6-91db0294e63c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- vigabatrin
- Dosage form
- FOR SOLUTION
- Route
- ORAL
- Labeler
- Novadoz Pharmaceuticals LLC
- Application
- ANDA215363
- Marketing category
- ANDA
- Marketing start
- 2022-09-07
- 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
- Vigabatrin
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72205-093-50 | Vigabatrin | 50 in 1 CARTON | FOR SOLUTION | 50 | | 1 |
| 72205-093-61 | Vigabatrin | 10 mL in 1 PACKET | FOR SOLUTION | 10 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72205-093 | VIGABATRIN FOR SOLUTION [NOVADOZ PHARMACEUTICALS LLC] | 1 | Current NDC, Legacy NDC, 2 package rows | 20220911_082d818a-4f4e-4675-98c6-91db0294e63c.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 |
|---|
| 72205-093-50 | 72205009350 | 50 PACKET in 1 CARTON (72205-093-50) / 10 mL in 1 PACKET (72205-093-61) | 50 packet | 2022-09-08 | 0000-00-00 | No | No | Current |
| 72205-093-61 | 72205009361 | 10 mL in 1 PACKET | 10 ml | | | | | Historical |