Pregabalin
- Product NDC
- 71610-808
- 11-digit product format
- 716100808
- Labeler code
- 71610
- Product ID
- 71610-808_4229e9d6-f6fb-ce42-e063-6294a90a09c0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pregabalin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA208677
- Marketing category
- ANDA
- Marketing start
- 2021-08-24
- Substance
- PREGABALIN
- Active strength
- 100 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 |
|---|
| 71610-808-30 | 71610080830 | 30 CAPSULE in 1 BOTTLE (71610-808-30) | 30 capsule | 2024-03-26 | No | No | Historical |
| 71610-808-53 | 71610080853 | 60 CAPSULE in 1 BOTTLE (71610-808-53) | 60 capsule | 2024-03-26 | No | No | Historical |
| 71610-808-54 | 71610080854 | 84 CAPSULE in 1 BOTTLE (71610-808-54) | 84 capsule | 2025-10-24 | No | No | Historical |
| 71610-808-60 | 71610080860 | 90 CAPSULE in 1 BOTTLE (71610-808-60) | 90 capsule | 2024-03-26 | No | No | Historical |
| 71610-808-70 | 71610080870 | 120 CAPSULE in 1 BOTTLE (71610-808-70) | 120 capsule | 2024-03-26 | No | No | Historical |
| 71610-808-75 | 71610080875 | 150 CAPSULE in 1 BOTTLE (71610-808-75) | 150 capsule | 2025-10-24 | No | No | Historical |
| 71610-808-80 | 71610080880 | 180 CAPSULE in 1 BOTTLE (71610-808-80) | 180 capsule | 2025-10-24 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Pregabalin | Aphena Pharma Solutions - Tennessee, LLC | 2025-10-27 | HUMAN PRESCRIPTION DRUG LABEL | 2 |
| Pregabalin | Aphena Pharma Solutions - Tennessee, LLC | 2024-03-28 | HUMAN PRESCRIPTION DRUG LABEL | 1 |