Pregabalin
- Product NDC
- 71610-754
- 11-digit product format
- 716100754
- Labeler code
- 71610
- Product ID
- 71610-754_24954641-a737-4056-89df-792b0d0589d7
- 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
- 2019-07-19
- Substance
- PREGABALIN
- Active strength
- 200 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 |
|---|
| 71610-754-30 | 71610075430 | 30 CAPSULE in 1 BOTTLE (71610-754-30) | 30 capsule | 2023-11-28 | No | No | Historical |
| 71610-754-46 | 71610075446 | 56 CAPSULE in 1 BOTTLE (71610-754-46) | 56 capsule | 2023-11-28 | No | No | Historical |
| 71610-754-53 | 71610075453 | 60 CAPSULE in 1 BOTTLE (71610-754-53) | 60 capsule | 2023-11-28 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Pregabalin | Aphena Pharma Solutions - Tennessee, LLC | 2023-11-28 | HUMAN PRESCRIPTION DRUG LABEL | 1 |