Pregabalin
- Product NDC
- 50228-648
- 11-digit product format
- 502280648
- Labeler code
- 50228
- Product ID
- 50228-648_459f0d45-9805-26f8-e063-6394a90a7e6e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PREGABALIN
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- ScieGen Pharmaceuticals, Inc
- Application
- ANDA208677
- Marketing category
- ANDA
- Marketing start
- 2025-12-10
- Substance
- PREGABALIN
- Active strength
- 100 mg/1
- DEA schedule
- CV
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Pregabalin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PREGABALIN | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 55JG375S6M |
| Rxcui | 483438, 483440, 483442, 483444, 483446, 483448, 483450, 577127 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50228-648-05 | Pregabalin | 500 in 1 BOTTLE | CAPSULE | 500 | | 1 |
| 50228-648-90 | Pregabalin | 90 in 1 BOTTLE | CAPSULE | 90 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 50228-648-05 | 50228064805 | 500 CAPSULE in 1 BOTTLE (50228-648-05) | 500 capsule | 2025-12-10 | No | No | Historical |
| 50228-648-90 | 50228064890 | 90 CAPSULE in 1 BOTTLE (50228-648-90) | 90 capsule | 2025-12-10 | No | No | Historical |