Pregabalin
- Product NDC
- 68788-8472
- 11-digit product format
- 687888472
- Labeler code
- 68788
- Product ID
- 68788-8472_3e21499d-c54c-47a3-8738-45e1043c7b8f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pregabalin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA206912
- Marketing category
- ANDA
- Marketing start
- 2023-06-29
- Substance
- PREGABALIN
- Active strength
- 50 mg/1
- DEA schedule
- CV
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 55JG375S6M | PREGABALIN | 148553-50-8 | PREGABALIN |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-8472-1 | 68788847201 | 100 CAPSULE in 1 BOTTLE (68788-8472-1) | 100 capsule | 2023-06-29 | No | No | Historical |
| 68788-8472-3 | 68788847203 | 30 CAPSULE in 1 BOTTLE (68788-8472-3) | 30 capsule | 2023-06-29 | No | No | Historical |
| 68788-8472-6 | 68788847206 | 60 CAPSULE in 1 BOTTLE (68788-8472-6) | 60 capsule | 2023-06-29 | No | No | Historical |
| 68788-8472-9 | 68788847209 | 90 CAPSULE in 1 BOTTLE (68788-8472-9) | 90 capsule | 2023-06-29 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Pregabalin | Preferred Pharmaceuticals Inc. | 2025-09-11 | HUMAN PRESCRIPTION DRUG LABEL | 3 |