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 | Bryant Ranch Prepack | 08ad87e3-e00c-46d1-98f8-df493cf1712e | 2024-09-06 | Warnings, Adverse reactions | ANDA207799 483440 55JG375S6M |
| Pregabalin | PREGABALIN | Bryant Ranch Prepack | 8923d776-b374-4c06-a208-abeffb1ba578 | 2024-09-06 | Warnings, Adverse reactions | ANDA207799 483442 55JG375S6M |
| Pregabalin | PREGABALIN | Bryant Ranch Prepack | fac0eb4e-12ef-4e8e-8cbe-c43c26f0faee | 2024-08-23 | Warnings, Adverse reactions | 483442 55JG375S6M |
| Pregabalin | PREGABALIN | Advanced Rx Pharmacy of Tennessee, LLC | f98c5df7-9b85-eacc-e053-6294a90a88ec | 2024-08-22 | Warnings, Adverse reactions | 483442 483448 55JG375S6M |
| Pregabalin | PREGABALIN | Bryant Ranch Prepack | c72b0bed-b7b4-4ae1-914e-756d76b66ed9 | 2024-08-20 | Warnings, Adverse reactions | 483450 55JG375S6M |
| Pregabalin | PREGABALIN | Bryant Ranch Prepack | aac1f2f4-5ef5-49dd-b914-54f2cf2b1bc1 | 2024-08-12 | Warnings, Adverse reactions | 483438 55JG375S6M |
| Pregabalin | PREGABALIN | Bryant Ranch Prepack | b2d45d41-a787-4912-962d-0bd98b70d58a | 2024-08-12 | Warnings, Adverse reactions | 483446 55JG375S6M |
| Pregabalin | PREGABALIN | Bryant Ranch Prepack | 616b37d6-93d5-44de-a993-bddf59eaee9a | 2024-08-12 | Warnings, Adverse reactions | 483440 55JG375S6M |
| Pregabalin | PREGABALIN | Aphena Pharma Solutions - Tennessee, LLC | 8bb9495e-1354-4a70-baa5-9b80eb3518c8 | 2024-07-28 | Warnings, Adverse reactions | 483440 55JG375S6M |
| Pregabalin | PREGABALIN | Aphena Pharma Solutions - Tennessee, LLC | aa55a53c-96f6-4e0a-8b1d-e9d36e6ef2ec | 2024-07-28 | Warnings, Adverse reactions | 483440 483448 55JG375S6M |
| Pregabalin | PREGABALIN | Bryant Ranch Prepack | 29a869b8-0d9f-4e3f-820a-061aa42ee482 | 2024-07-16 | Warnings, Adverse reactions | 483438 55JG375S6M |
| Pregabalin | PREGABALIN | Bryant Ranch Prepack | d70a5102-eb8d-45f1-acd0-692e9208428e | 2024-07-08 | Warnings, Adverse reactions | 577127 55JG375S6M |
| Pregabalin | PREGABALIN | Bryant Ranch Prepack | 59f94cd9-0fc9-4e55-8004-578971a1b42f | 2024-07-08 | Warnings, Adverse reactions | 483444 55JG375S6M |
| Pregabalin | PREGABALIN | American Health Packaging | 59da1a16-d409-49eb-9b44-397c77006043 | 2024-06-13 | Warnings, Adverse reactions | 483440 483442 483448 483438 483450 55JG375S6M |
| Pregabalin | PREGABALIN | Advanced Rx of Tennessee, LLC | 1a15cd11-0db9-2bc8-e063-6394a90a11fb | 2024-06-05 | Warnings, Adverse reactions | 483440 577127 55JG375S6M |
| PREGABALIN | PREGABALIN | Bryant Ranch Prepack | 15b5e3d0-2bad-4363-99cb-e15819c41fda | 2024-05-20 | Warnings, Adverse reactions | 483444 55JG375S6M |
| Pregabalin | PREGABALIN | Aphena Pharma Solutions - Tennessee, LLC | 15ea709a-d502-41ea-e063-6394a90ad97d | 2024-04-12 | Warnings, Adverse reactions | 483448 55JG375S6M |
| Pregabalin | PREGABALIN | Aphena Pharma Solutions - Tennessee, LLC | 124d7552-e48d-b160-e063-6294a90a196f | 2024-02-26 | Warnings, Adverse reactions | 483444 55JG375S6M |
| Pregabalin | PREGABALIN | Aphena Pharma Solutions - Tennessee, LLC | 11fe25cd-1aca-0e63-e063-6394a90a197e | 2024-02-22 | Warnings, Adverse reactions | 483450 55JG375S6M |
| Pregabalin | PREGABALIN | Aphena Pharma Solutions - Tennessee, LLC | 4ed3e73c-13e7-4646-874d-276b6c75d2c9 | 2024-02-08 | Warnings, Adverse reactions | 483442 55JG375S6M |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.