PREGABALIN
- Product NDC
- 80425-0417
- 11-digit product format
- 804250417
- Labeler code
- 80425
- Product ID
- 80425-0417_27606bf8-5738-d374-e063-6394a90a10f9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PREGABALIN
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLC
- Application
- ANDA207799
- Marketing category
- ANDA
- Marketing start
- 2024-07-03
- 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 |
|---|
| 80425-0417-1 | 80425041701 | 30 CAPSULE in 1 BOTTLE (80425-0417-1) | 30 capsule | 2024-07-03 | No | No | Historical |
| 80425-0417-2 | 80425041702 | 60 CAPSULE in 1 BOTTLE (80425-0417-2) | 60 capsule | 2024-07-03 | No | No | Historical |
| 80425-0417-3 | 80425041703 | 90 CAPSULE in 1 BOTTLE (80425-0417-3) | 90 capsule | 2024-07-03 | No | No | Historical |
| 80425-0417-4 | 80425041704 | 120 CAPSULE in 1 BOTTLE (80425-0417-4) | 120 capsule | 2024-11-20 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Pregabalin Capsules | Advanced Rx Pharmacy of Tennessee, LLC | 2024-11-20 | HUMAN PRESCRIPTION DRUG LABEL | 7 |