Pregabalin
- Product NDC
- 69367-431
- 11-digit product format
- 693670431
- Labeler code
- 69367
- Product ID
- 69367-431_da37b9bc-466b-4bef-8c28-36586538df59
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pregabalin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Westminster Pharmaceuticals, LLC
- Application
- ANDA212988
- Marketing category
- ANDA
- Marketing start
- 2025-11-17
- Substance
- PREGABALIN
- Active strength
- 300 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 | 300 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 |
|---|
| 69367-431-05 | Pregabalin | 500 in 1 BOTTLE | CAPSULE | 500 | | 2 |
| 69367-431-09 | Pregabalin | 90 in 1 BOTTLE | CAPSULE | 90 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 69367-431-05 | 69367043105 | 500 CAPSULE in 1 BOTTLE (69367-431-05) | 500 capsule | 2025-11-17 | No | No | Historical |
| 69367-431-09 | 69367043109 | 90 CAPSULE in 1 BOTTLE (69367-431-09) | 90 capsule | 2025-11-17 | No | No | Historical |