NDC 80425-0185-01 - PREGABALIN
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 80425-0185
- Requested NDC
- 80425-0185-01
- Package NDCs from labels
- 80425-0185-3, 80425-0185-2, 80425-0185-1, 80425-0185-01
- Manufacturer
- Advanced Rx Pharmacy of Tennessee, LLC
- Effective date
- 2024-11-20
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| PREGABALIN - Advanced Rx Pharmacy of Tennessee, LLC | Advanced Rx Pharmacy of Tennessee, LLC | 2024-11-20 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80425-0185-1 | PREGABALIN | 30 in 1 BOTTLE | CAPSULE | 30 | 7 | |
| 80425-0185-2 | PREGABALIN | 60 in 1 BOTTLE | CAPSULE | 60 | 7 | |
| 80425-0185-3 | PREGABALIN | 90 in 1 BOTTLE | CAPSULE | 90 | 7 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 80425-0185 | PREGABALIN CAPSULE [ADVANCED RX PHARMACY OF TENNESSEE, LLC] | 7 | Current NDC, Legacy NDC, 3 package rows | 20241123_d2813712-d7f6-6144-e053-2995a90a3c5d.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 80425-0185-1 | EA - Each | 80425-0185 | 3270f391-a2ec-4234-98e0-d8c13c5e22b2 | 1 | 2023-06-06 |
| 80425-0185-2 | EA - Each | 80425-0185 | 5620b3dd-776c-4ee1-92f2-73b7f26c6d91 | 1 | 2023-04-07 |
| 80425-0185-3 | EA - Each | 80425-0185 | 834c3e53-a203-4dd9-898a-20b7bd89e8bd | 1 | 2023-04-07 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Pregabalin | PREGABALIN | Advanced Rx of Tennessee, LLC | afc8c76e-9b21-7ddb-e053-2a95a90ad736 | 2024-12-31 | Warnings, Adverse reactions | 483450 55JG375S6M |
| Pregabalin | PREGABALIN | Advanced Rx of Tennessee, LLC | af739a0d-a3cd-754f-e053-2a95a90ad655 | 2024-12-31 | Warnings, Adverse reactions | 483448 55JG375S6M |
| Pregabalin | PREGABALIN | Advanced Rx Pharmacy of Tennessee, LLC | d28168cd-9b7a-f8df-e053-2995a90ad97f | 2024-12-31 | Warnings, Adverse reactions | 483440 55JG375S6M |
| Pregabalin | PREGABALIN | Advanced Rx Pharmacy of Tennessee, LLC | b8172d6b-a646-e559-e053-2a95a90ac24d | 2024-12-31 | Warnings, Adverse reactions | 483440 55JG375S6M |
| Pregabalin | PREGABALIN | Advanced Rx Pharmacy of Tennessee, LLC | bc1b143d-feaf-9498-e053-2995a90acf50 | 2024-12-31 | Warnings, Adverse reactions | 483444 55JG375S6M |
| Pregabalin | PREGABALIN | Advanced Rx Pharmacy of Tennessee, LLC | b817083c-b535-2269-e053-2a95a90af5b9 | 2024-12-31 | Warnings, Adverse reactions | 483438 55JG375S6M |
| Pregabalin | PREGABALIN | Advanced Rx Pharmacy of Tennessee, LLC | c6b456ca-9d07-7789-e053-2a95a90a20c5 | 2024-12-31 | Warnings, Adverse reactions | 483450 55JG375S6M |
| Pregabalin | PREGABALIN | Advanced Rx Pharmacy of Tennessee, LLC | c8bfc4f9-6208-4eaa-e053-2a95a90ada97 | 2024-12-31 | Warnings, Adverse reactions | 483438 55JG375S6M |
| Pregabalin | PREGABALIN | Advanced Rx Pharmacy of Tennessee, LLC | c8acdbcf-3076-63b2-e053-2a95a90aa3c4 | 2024-12-31 | Warnings, Adverse reactions | 483448 55JG375S6M |
| Pregabalin | PREGABALIN | Advanced Rx Pharmacy of Tennessee, LLC | c89a3514-f637-e54f-e053-2a95a90a6881 | 2024-12-31 | Warnings, Adverse reactions | ANDA207799 483444 55JG375S6M |
| Pregabalin | PREGABALIN | Advanced Rx Pharmacy of Tennessee, LLC | d2804923-a466-6dc6-e053-2a95a90a4182 | 2024-12-31 | Warnings, Adverse reactions | 483444 55JG375S6M |
| Pregabalin | PREGABALIN | Advanced Rx Pharmacy of Tennessee, LLC | f5d9b625-783c-bd78-e053-2995a90a37d2 | 2024-12-31 | Warnings, Adverse reactions | 483438 55JG375S6M |
| Pregabalin | PREGABALIN | Advanced Rx Pharmacy of Tennessee, LLC | f8ae62be-3a68-be6b-e053-6394a90ab627 | 2024-12-31 | Warnings, Adverse reactions | 483446 55JG375S6M |
| Pregabalin | PREGABALIN | Aphena Pharma Solutions - Tennessee, LLC | 29b91992-c853-a57d-e063-6394a90ab365 | 2024-12-20 | Warnings, Adverse reactions | 483438 55JG375S6M |
| Pregabalin | PREGABALIN | Quality Care Products, LLC | 59432752-c8d8-4396-95dd-0e04c55bc82b | 2024-12-19 | Warnings, Adverse reactions | 483446 55JG375S6M |
| Pregabalin | PREGABALIN | Quality Care Products, LLC | 1e087436-0534-4de2-b310-a5cc0e46adbd | 2024-12-18 | Warnings, Adverse reactions | 483442 55JG375S6M |
| PREGABALIN | PREGABALIN | Quality Care Products, LLC | ff386af0-17d3-4f95-803b-b51cb79e5295 | 2024-12-18 | Warnings, Adverse reactions | 483440 483448 483438 483450 55JG375S6M |
| PREGABALIN | PREGABALIN | Advanced Rx Pharmacy of Tennessee, LLC | d2813712-d7f6-6144-e053-2995a90a3c5d | 2024-11-20 | Warnings, Adverse reactions | ANDA207799 80425-0417-4 80425-0185-3 80425-0185-1 80425-0185-2 80425-0421-2 80425-0417-1 80425-0417-2 80425-0421-1 80425-0421-3 80425-0417-3 80425-0185 80425-0421 80425-0417 80425018501 483440 483448 483450 27606bf8-5738-d374-e063-6394a90a10f9 d2813712-d7f6-6144-e053-2995a90a3c5d 55JG375S6M |
| Pregabalin | PREGABALIN | Bryant Ranch Prepack | 4cda70e8-9ae1-4958-8c86-1bc633be982b | 2024-09-06 | Warnings, Adverse reactions | ANDA207799 483448 55JG375S6M |
| Pregabalin | PREGABALIN | Bryant Ranch Prepack | cf7f0fd0-bac2-4836-9363-79d32ad0cc10 | 2024-09-06 | Warnings, Adverse reactions | ANDA207799 483438 55JG375S6M |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.