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 | Aphena Pharma Solutions - Tennessee, LLC | 3e9cfeb9-1e2b-ea79-e063-6394a90a67b1 | 2025-09-12 | Warnings, Adverse reactions | 577127 55JG375S6M |
| Pregabalin | PREGABALIN | Preferred Pharmaceuticals Inc. | e8e272a4-c181-4573-822b-2bb315b6ad37 | 2025-09-12 | Warnings, Adverse reactions | ANDA207799 483438 55JG375S6M |
| PREGABALIN | PREGABALIN | Cadila Pharmaceuticals Limited | 170c0c95-2ee8-4dff-bbd6-b87a21e8cf81 | 2025-09-12 | Warnings, Adverse reactions | 483440 483444 483442 577127 483448 483438 483450 483446 55JG375S6M |
| Pregabalin | PREGABALIN | Preferred Pharmaceuticals, Inc. | ceedde96-fdaf-4708-9ca1-e48e052cde75 | 2025-09-12 | Warnings, Adverse reactions | 483438 55JG375S6M |
| Pregabalin | PREGABALIN | Preferred Pharmaceuticals Inc. | a0da0534-b386-4c93-ae89-03b0e3325e02 | 2025-09-11 | Warnings, Adverse reactions | ANDA207799 483450 55JG375S6M |
| Pregabalin | PREGABALIN | Preferred Pharmaceuticals, Inc. | 1760ccdc-46f7-4182-a563-96b13212cb7e | 2025-09-11 | Warnings, Adverse reactions | 483450 55JG375S6M |
| Pregabalin | PREGABALIN | Preferred Pharmaceuticals, Inc. | 3dbfd868-8408-4514-ba1c-04a5d095c16a | 2025-09-10 | Warnings, Adverse reactions | 483448 55JG375S6M |
| Pregabalin | PREGABALIN | Aphena Pharma Solutions - Tennessee, LLC | 31e7caf6-0a8b-f343-e063-6294a90ad729 | 2025-09-08 | Warnings, Adverse reactions | 483438 55JG375S6M |
| PREGABALIN | PREGABALIN | Rising Pharma Holdings, Inc. | dbebfa61-0685-41b4-8364-00b8d8b73714 | 2025-09-05 | Warnings, Adverse reactions | 483440 483444 483442 577127 483448 483438 483450 483446 55JG375S6M |
| Pregabalin | PREGABALIN | Novadoz Pharmaceuticals LLC | 193666f7-3c55-43b1-947a-2ffec40c687f | 2025-08-28 | Warnings, Adverse reactions | 483440 483444 483442 577127 483448 483438 483450 483446 55JG375S6M |
| pregabalin | PREGABALIN | Indoco Remedies Limited | 0a8d9e35-46fd-4c70-bb7f-4e8b754f2794 | 2025-08-25 | Warnings, Adverse reactions | 483440 483444 483442 577127 483448 483438 483450 483446 55JG375S6M |
| Pregabalin | PREGABALIN | Aphena Pharma Solutions - Tennessee, LLC | 3c6daa12-5284-d9f1-e063-6294a90ae060 | 2025-08-15 | Warnings, Adverse reactions | 483438 55JG375S6M |
| Pregabalin | PREGABALIN | Alembic Pharmaceuticals Inc. | cf7b4b67-b017-47ac-af3f-bde5bd07bb0c | 2025-07-29 | Warnings, Adverse reactions | 483440 483444 483442 577127 483448 483438 483450 483446 55JG375S6M |
| Pregabalin | PREGABALIN | Aphena Pharma Solutions - Tennessee, LLC | 3ab4efb3-1ae5-2504-e063-6294a90a6d1d | 2025-07-24 | Warnings, Adverse reactions | 483448 55JG375S6M |
| Pregabalin | PREGABALIN | Aphena Pharma Solutions - Tennessee, LLC | 3ab57054-02c2-5e28-e063-6294a90a71ab | 2025-07-24 | Warnings, Adverse reactions | 483442 55JG375S6M |
| Pregabalin | PREGABALIN | Aphena Pharma Solutions - Tennessee, LLC | 3a124f59-38c2-7280-e063-6394a90a43b4 | 2025-07-16 | Warnings, Adverse reactions | 483444 55JG375S6M |
| Pregabalin | PREGABALIN | Aphena Pharma Solutions - Tennessee, LLC | 3a1374f4-79dd-ebbc-e063-6394a90a53b0 | 2025-07-16 | Warnings, Adverse reactions | 483446 55JG375S6M |
| Pregabalin | PREGABALIN | Aphena Pharma Solutions - Tennessee, LLC | ef7c2e2c-c314-4bfd-a9fa-39f0b0884d34 | 2025-07-11 | Warnings, Adverse reactions | 483450 55JG375S6M |
| Pregabalin | PREGABALIN | Amneal Pharmaceuticals NY LLC | 3099759f-cb24-40e8-b482-9388c38c73b9 | 2025-06-19 | Warnings, Adverse reactions | 483440 483444 483442 577127 483448 483438 483450 483446 55JG375S6M |
| Pregabalin | PREGABALIN | MARKSANS PHARMA LIMITED | b2b81bb6-5423-4221-8a61-f70a38d6a1e9 | 2025-06-10 | Warnings, Adverse reactions | 483440 483444 483442 577127 483448 483438 483450 483446 55JG375S6M |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.