NDC 80425-0288-01 - Topiramate
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
- 80425-0288
- Requested NDC
- 80425-0288-01
- Package NDCs from labels
- 80425-0288-1, 80425-0288-2, 80425-0288-3, 80425-0288-4, 80425-0288-01
- 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 |
|---|---|---|---|
| Topiramate - 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 |
|---|---|---|---|---|---|---|
| 80425-0288-1 | Topiramate | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 3 | |
| 80425-0288-2 | Topiramate | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | 3 | |
| 80425-0288-3 | Topiramate | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | 3 | |
| 80425-0288-4 | Topiramate | 270 in 1 BOTTLE | TABLET, FILM COATED | 270 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 80425-0288 | TOPIRAMATE TABLET, FILM COATED [ADVANCED RX PHARMACY OF TENNESSEE, LLC] | 3 | Current NDC, 4 package rows | 20250102_f781ada8-f90d-b233-e053-6394a90a87ff.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 80425-0288-1 | EA - Each | 80425-0288 | 9fbfba24-cf2a-4e1a-80a5-67637f87c9c7 | 1 | 2023-04-07 |
| 80425-0288-2 | EA - Each | 80425-0288 | 36543b72-ad68-45cd-9599-fb59429f30b5 | 1 | 2023-04-07 |
| 80425-0288-3 | EA - Each | 80425-0288 | 00c10f76-0d12-4caa-9194-58853a5a9c36 | 1 | 2023-04-07 |
| 80425-0288-4 | EA - Each | 80425-0288 | a332c281-bc27-4da9-9192-db431088f371 | 1 | 2023-09-05 |
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 |
|---|---|---|---|---|---|---|
| Topiramate | TOPIRAMATE | Upsher-Smith Laboratories, LLC | 691d276c-9cc1-4d39-828f-0f44d7ef6328 | 2026-05-15 | Warnings, Adverse reactions | 0H73WJJ391 |
| Topiramate | TOPIRAMATE | Vitruvias Therapeutics, Inc. | a9d7c5ef-daf9-4f97-8673-7f4a2007f408 | 2026-05-07 | Warnings, Adverse reactions | 0H73WJJ391 |
| TOPIRAMATE | TOPIRAMATE | Glenmark Pharmaceuticals Inc., USA | 54bfabce-1f8a-40ee-8b55-efce8fe6fbf1 | 2026-04-30 | Warnings, Adverse reactions | 0H73WJJ391 |
| topiramate | TOPIRAMATE | Coupler LLC | 50b10a3d-883c-8891-e063-6394a90a86a1 | 2026-04-30 | Warnings, Adverse reactions | ANDA090162 151226 0H73WJJ391 |
| Topiramate | TOPIRAMATE | Glenmark Pharmaceuticals Inc., USA | 872927eb-0b61-44bb-9892-3c700b6f2181 | 2026-04-29 | Warnings, Adverse reactions | 0H73WJJ391 |
| topiramate | TOPIRAMATE | Quallent Pharmaceuticals Health LLC | 9dae6824-6913-42de-b98a-cdcb0d3b4a46 | 2026-04-25 | Warnings, Adverse reactions | 151226 199889 199888 0H73WJJ391 |
| Qsymia | PHENTERMINE AND TOPIRAMATE | Vivus LLC | 40dd5602-53da-45ac-bb4b-15789aba40f9 | 2026-04-22 | Warnings, Adverse reactions | 0H73WJJ391 |
| topiramate | TOPIRAMATE | Zydus Pharmaceuticals USA Inc. | e4886adf-199d-4b19-a4ef-75f8f94cb54e | 2026-04-22 | Warnings, Adverse reactions | 0H73WJJ391 |
| Topiramate | TOPIRAMATE | Ajanta Pharma USA Inc. | b94629e3-ae2e-473e-b2f5-06e32ee19aa9 | 2026-04-20 | Warnings, Adverse reactions | 0H73WJJ391 |
| Topiramate | TOPIRAMATE | Zydus Pharmaceuticals USA Inc. | a5ca2fce-bd2d-40db-b963-e3ec27c8bf23 | 2026-04-16 | Warnings, Adverse reactions | 0H73WJJ391 |
| topiramate | TOPIRAMATE | Zydus Pharmaceuticals USA Inc. | 67dcdd6e-48bc-418e-a887-805929d83ce0 | 2026-04-15 | Warnings, Adverse reactions | 199890 151226 199889 199888 0H73WJJ391 |
| Topiramate | TOPIRAMATE | Glenmark Pharmaceuticals Inc., USA | 35312f49-decf-428d-bf5f-4215b762ed3c | 2026-04-10 | Warnings, Adverse reactions | 199890 151226 199889 199888 0H73WJJ391 |
| topiramate | TOPIRAMATE | Unichem Pharmaceuticals (USA), Inc. | 6ee00e82-799d-445e-b658-a9712c49a28e | 2026-04-06 | Warnings, Adverse reactions | ANDA090162 29300-115 199890 151226 199889 199888 961973db-b7ab-40fa-ad75-4163738def9b 6ee00e82-799d-445e-b658-a9712c49a28e 0H73WJJ391 |
| Topiramate | TOPIRAMATE | Advagen Pharma Ltd | 48169bbc-4fb2-4bc4-9bdd-de71bf7722df | 2026-04-03 | Warnings, Adverse reactions | 0H73WJJ391 |
| Topiramate | TOPIRAMATE | Teva Pharmaceuticals, Inc. | 4f20155f-05b9-40ec-af34-3b58aa8d60d4 | 2026-04-01 | Warnings, Adverse reactions | 0H73WJJ391 |
| Phentermine and Topiramate Extended-Release | PHENTERMINE AND TOPIRAMATE EXTENDED-RELEASE | Dr.Reddys Laboratories Inc | 260c3f90-163d-0bdd-1099-55d18a900e68 | 2026-03-31 | Warnings, Adverse reactions | 0H73WJJ391 |
| Topiramate | TOPIRAMATE | Zydus Pharmaceuticals USA Inc. | f72774dd-c7eb-41f9-9837-02baf77cc523 | 2026-03-30 | Warnings, Adverse reactions | 0H73WJJ391 |
| Topiramate | TOPIRAMATE | Lupin Pharmaceuticals, Inc. | e310afcd-1260-434e-a994-34549c789d99 | 2026-03-30 | Warnings, Adverse reactions | 0H73WJJ391 |
| Topiramate | TOPIRAMATE | Aurobindo Pharma Limited | 32b48ea0-a215-43b8-83b4-a5435a686d68 | 2026-03-24 | Warnings, Adverse reactions | 199890 151226 199889 199888 0H73WJJ391 |
| TOPIRAMATE | TOPIRAMATE | Aurobindo Pharma Limited | d1588c37-9da9-4ccb-b78a-64234938a115 | 2026-03-24 | Warnings, Adverse reactions | 0H73WJJ391 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.