Pregabalin
- Product NDC
- 71610-925
- 11-digit product format
- 716100925
- Labeler code
- 71610
- Product ID
- 71610-925_3a124115-06a2-688c-e063-6394a90af648
- 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
- 300 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 |
|---|
| 71610-925-30 | 71610092530 | 30 CAPSULE in 1 BOTTLE (71610-925-30) | 30 capsule | 2025-07-16 | No | No | Historical |
| 71610-925-46 | 71610092546 | 56 CAPSULE in 1 BOTTLE (71610-925-46) | 56 capsule | 2025-07-16 | No | No | Historical |
| 71610-925-53 | 71610092553 | 60 CAPSULE in 1 BOTTLE (71610-925-53) | 60 capsule | 2025-07-16 | No | No | Historical |
| 71610-925-60 | 71610092560 | 90 CAPSULE in 1 BOTTLE (71610-925-60) | 90 capsule | 2025-07-16 | No | No | Historical |
| 71610-925-80 | 71610092580 | 180 CAPSULE in 1 BOTTLE (71610-925-80) | 180 capsule | 2025-07-16 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Pregabalin | Aphena Pharma Solutions - Tennessee, LLC | 2025-07-16 | HUMAN PRESCRIPTION DRUG LABEL | 1 |