Pregabalin
- Product NDC
- 71610-882
- 11-digit product format
- 716100882
- Labeler code
- 71610
- Product ID
- 71610-882_85053f33-9372-4fd6-b67b-0e7cc1b063c5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pregabalin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA209357
- Marketing category
- ANDA
- Marketing start
- 2019-07-19
- 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 |
|---|
| 71610-882-46 | 71610088246 | 56 CAPSULE in 1 BOTTLE (71610-882-46) | 56 capsule | 2025-02-24 | No | No | Historical |
| 71610-882-53 | 71610088253 | 60 CAPSULE in 1 BOTTLE (71610-882-53) | 60 capsule | 2025-02-24 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Pregabalin | Aphena Pharma Solutions - Tennessee, LLC | 2025-03-03 | Human Prescription Drug Label | 1 |