Pregabalin
- Product NDC
- 71610-765
- 11-digit product format
- 716100765
- Labeler code
- 71610
- Product ID
- 71610-765_769837cd-84ec-44df-b144-d3366847e9e0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PREGABALIN
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA211384
- Marketing category
- ANDA
- Marketing start
- 2019-07-19
- Substance
- PREGABALIN
- Active strength
- 75 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 |
|---|
| 71610-765-30 | 71610076530 | 30 CAPSULE in 1 BOTTLE (71610-765-30) | 30 capsule | 2023-12-20 | No | No | Historical |
| 71610-765-46 | 71610076546 | 56 CAPSULE in 1 BOTTLE (71610-765-46) | 56 capsule | 2023-12-20 | No | No | Historical |
| 71610-765-53 | 71610076553 | 60 CAPSULE in 1 BOTTLE (71610-765-53) | 60 capsule | 2023-12-20 | No | No | Historical |
| 71610-765-70 | 71610076570 | 120 CAPSULE in 1 BOTTLE (71610-765-70) | 120 capsule | 2023-12-20 | No | No | Historical |
| 71610-765-75 | 71610076575 | 150 CAPSULE in 1 BOTTLE (71610-765-75) | 150 capsule | 2025-07-08 | No | No | Historical |
| 71610-765-80 | 71610076580 | 180 CAPSULE in 1 BOTTLE (71610-765-80) | 180 capsule | 2025-07-08 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Pregabalin | Aphena Pharma Solutions - Tennessee, LLC | 2025-07-11 | HUMAN PRESCRIPTION DRUG LABEL | 2 |