NDC 80425-0177-01 - 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
- 80425-0177
- Requested NDC
- 80425-0177-01
- Package NDCs from labels
- 80425-0177-3, 80425-0177-1, 80425-0177-2, 80425-0177-01
- Manufacturer
- Advanced Rx Pharmacy of Tennessee, LLC
- Effective date
- 2024-12-31
- 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 | 2024-12-31 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80425-0177-1 | Pregabalin | 30 in 1 BOTTLE | CAPSULE | 30 | 5 | |
| 80425-0177-2 | Pregabalin | 60 in 1 BOTTLE | CAPSULE | 60 | 5 | |
| 80425-0177-3 | Pregabalin | 90 in 1 BOTTLE | CAPSULE | 90 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 80425-0177 | PREGABALIN CAPSULE [ADVANCED RX PHARMACY OF TENNESSEE, LLC] | 5 | Current NDC, Legacy NDC, 3 package rows | 20250101_d2804923-a466-6dc6-e053-2a95a90a4182.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 80425-0177-1 | EA - Each | 80425-0177 | 44662712-df1a-4896-9249-284265b597be | 1 | 2023-06-06 |
| 80425-0177-2 | EA - Each | 80425-0177 | d1d76d48-fe74-4725-8c21-9e225e4c66fe | 1 | 2023-06-06 |
| 80425-0177-3 | EA - Each | 80425-0177 | 878608ec-359c-4d4d-996c-df069331357c | 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 | Dr.Reddys Laboratories Inc | ceed457b-8f43-4021-fd70-071c96e09470 | 2025-05-20 | Warnings, Adverse reactions | 483440 483444 483442 577127 483448 483438 483450 483446 55JG375S6M |
| Pregablin | PREGABLIN | Macleods Pharmaceuticals Limited | a3a94949-3060-4057-9b29-e06a808cbd76 | 2025-05-14 | Warnings, Adverse reactions | 483440 483444 483442 577127 483448 483438 483450 483446 55JG375S6M |
| Pregabalin | PREGABALIN | Cipla USA, Inc. | 17a8087c-579f-42de-ae92-006ea64def2a | 2025-05-01 | Warnings, Adverse reactions | 483440 483444 483442 577127 483448 483438 483450 483446 55JG375S6M |
| Pregabalin | PREGABALIN | Exelan Pharmaceuticals Inc. | 3fdc6e94-2504-416c-81dd-2db9bc194ebb | 2025-05-01 | Warnings, Adverse reactions | 483440 483444 483442 577127 483448 483438 483450 483446 55JG375S6M |
| Lyrica | PREGABALIN | Viatris Specialty LLC | d4734e7d-5079-455e-8ff5-8f4539c998a9 | 2025-04-15 | Warnings, Adverse reactions | 483440 483444 483442 577127 483448 483438 483450 483446 55JG375S6M |
| Pregabalin | PREGABALIN | Mylan Pharmaceuticals Inc. | ebe34db4-816d-4f0a-adbb-826693662754 | 2025-04-12 | Warnings, Adverse reactions | 55JG375S6M |
| Pregabalin | PREGABALIN | Aphena Pharma Solutions - Tennessee, LLC | b1f4b888-ac88-4250-8db1-706e7cc01e93 | 2025-03-21 | Warnings, Adverse reactions | 483444 55JG375S6M |
| Pregabalin | PREGABALIN | Aphena Pharma Solutions - Tennessee, LLC | b0f34220-0657-4868-ae01-014f9300f622 | 2025-03-03 | Warnings, Adverse reactions | 483448 55JG375S6M |
| Pregabalin | PREGABALIN | Proficient Rx LP | 580955ba-86f6-4e86-b0fa-dd44e8828b0e | 2025-03-01 | Warnings, Adverse reactions | 483450 55JG375S6M |
| Pregabalin | PREGABALIN | Proficient Rx LP | a025e4fc-e0c1-4c5b-a1c8-bd8e578a737e | 2025-03-01 | Warnings, Adverse reactions | 483450 55JG375S6M |
| Pregabalin | PREGABALIN | Coupler LLC | 2ccc641e-6859-046e-e063-6294a90a5017 | 2025-01-28 | Warnings, Adverse reactions | 483448 55JG375S6M |
| PREGABALIN | PREGABALIN | Direct_Rx | 8efb9652-86b9-4cb5-e053-2995a90adac0 | 2025-01-22 | Warnings, Adverse reactions | ANDA208677 483448 55JG375S6M |
| PREGABALIN | PREGABALIN | Direct_Rx | 8ee9e08f-cf87-599c-e053-2995a90a563c | 2025-01-22 | Warnings, Adverse reactions | ANDA208677 483450 55JG375S6M |
| PREGABALIN | PREGABALIN | Direct Rx | d88925b8-9be6-d862-e053-2995a90a1612 | 2025-01-21 | Adverse reactions | ANDA208677 577127 55JG375S6M |
| PREGABALIN | PREGABALIN | Direct_Rx | 91cf12b1-e1a6-dbc2-e053-2a95a90a8d5d | 2025-01-17 | Warnings, Adverse reactions | ANDA208677 483444 483442 577127 483438 483446 55JG375S6M |
| Pregabalin | PREGABALIN | Preferred Pharmaceuticals, Inc. | 8c3aedae-9745-4f63-ad64-a643f0245418 | 2025-01-16 | Warnings, Adverse reactions | ANDA208677 483444 55JG375S6M |
| Pregabalin | PREGABALIN | Proficient Rx LP | 2b87989d-6411-4996-8f05-05806ab80525 | 2025-01-01 | Warnings, Adverse reactions | 483448 55JG375S6M |
| Pregabalin | PREGABALIN | Advanced Rx of Tennessee, LLC | afc89ca3-5597-1c75-e053-2a95a90a3ff2 | 2024-12-31 | Warnings, Adverse reactions | 483450 55JG375S6M |
| Pregabalin | PREGABALIN | Advanced Rx of Tennessee, LLC | afd59273-75d1-5f33-e053-2995a90ab25f | 2024-12-31 | Warnings, Adverse reactions | 483448 55JG375S6M |
| Pregabalin | PREGABALIN | Advanced Rx of Tennessee, LLC | afc8d9f1-df31-607b-e053-2995a90a028c | 2024-12-31 | Warnings, Adverse reactions | 483448 55JG375S6M |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.