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 | Advanced Rx of Tennessee, LLC | 30ca2fce-4e4c-439e-e063-6294a90af076 | 2025-03-20 | Warnings, Adverse reactions | ANDA090162 151226 0H73WJJ391 |
| topiramate | TOPIRAMATE | Preferred Pharmaceuticals Inc. | bbf0f882-1dcc-415d-82bb-acc64f4dc2bc | 2025-02-21 | Warnings, Adverse reactions | ANDA090162 199889 0H73WJJ391 |
| topiramate | TOPIRAMATE | Preferred Pharmaceuticals Inc. | 288d6b40-8c87-4f16-85a7-86166b5ac77f | 2025-02-14 | Warnings, Adverse reactions | ANDA090162 151226 0H73WJJ391 |
| topiramate | TOPIRAMATE | Advanced Rx of Tennessee, LLC | 2cf7ce9e-afc2-f94e-e063-6394a90a35d0 | 2025-01-30 | Warnings, Adverse reactions | ANDA090162 199889 0H73WJJ391 |
| topiramate | TOPIRAMATE | Preferred Pharmaceuticals Inc. | 521be3f1-3ee7-45c7-9f0c-17e08b6c8fca | 2025-01-21 | Warnings, Adverse reactions | ANDA090162 199888 0H73WJJ391 |
| Topiramate | TOPIRAMATE | Proficient Rx LP | d63b64dd-b420-4283-9bac-92ba43c9f429 | 2025-01-01 | Warnings, Adverse reactions | 199889 0H73WJJ391 |
| Topiramate | TOPIRAMATE | Advanced Rx Pharmacy of Tennessee, LLC | eca774cf-2e4e-7642-e053-2a95a90a847d | 2024-12-31 | Warnings, Adverse reactions | 199888 0H73WJJ391 |
| Topiramate | TOPIRAMATE | Advanced Rx Pharmacy of Tennessee, LLC | d8dff98f-185e-77ba-e053-2995a90aed2f | 2024-12-31 | Warnings, Adverse reactions | 151226 0H73WJJ391 |
| Topiramate | TOPIRAMATE | Advanced Rx Pharmacy of Tennessee, LLC | f16065c0-9949-9ac4-e053-2995a90a3b02 | 2024-12-31 | Warnings, Adverse reactions | ANDA090162 151226 0H73WJJ391 |
| Topiramate | TOPIRAMATE | Advanced Rx Pharmacy of Tennessee, LLC | f781ada8-f90d-b233-e053-6394a90a87ff | 2024-12-31 | Warnings, Adverse reactions | ANDA090162 80425-0288-3 80425-0288-4 80425-0288-2 80425-0288-1 80425-0288 80425028801 199888 2a9bfe6a-6d66-b262-e063-6294a90a1cf3 f781ada8-f90d-b233-e053-6394a90a87ff 0H73WJJ391 |
| topiramate | TOPIRAMATE | Zydus Lifesciences Limited | 6f9d59e3-d10d-48f3-af01-83ba3e1e3a2b | 2024-10-25 | 0H73WJJ391 | |
| topiramate | TOPIRAMATE | A-S Medication Solutions | 8706a35d-5c39-4daf-b83a-65f3d630e043 | 2024-08-21 | Warnings, Adverse reactions | ANDA090162 199888 0H73WJJ391 |
| Topiramate | TOPIRAMATE | Bryant Ranch Prepack | 61390be3-7553-4cb5-b5da-7571ed7d4b17 | 2024-08-20 | Warnings, Adverse reactions | 199888 0H73WJJ391 |
| Topiramate | TOPIRAMATE | Bryant Ranch Prepack | ffaacad8-4594-45a8-b292-02a84cd0c35b | 2024-08-20 | Warnings, Adverse reactions | 151226 0H73WJJ391 |
| Topiramate | TOPIRAMATE | Advanced Rx Pharmacy of Tennessee, LLC | b353e7fb-b976-96d8-e053-2995a90a110a | 2024-08-14 | Warnings, Adverse reactions | 151226 0H73WJJ391 |
| topiramate | TOPIRAMATE | Zydus Lifesciences Limited | 57016639-89fe-43ad-89c4-5e7a756dddec | 2024-08-14 | 199890 151226 199889 199888 0H73WJJ391 | |
| topiramate | TOPIRAMATE | Bryant Ranch Prepack | 654f7c48-8c5d-4b97-88d6-397696f82b6a | 2024-08-08 | Warnings, Adverse reactions | ANDA090162 199888 0H73WJJ391 |
| topiramate | TOPIRAMATE | NuCare Pharmaceuticals,Inc. | 1ef1c408-30f7-51ee-e063-6394a90ac880 | 2024-08-05 | Warnings, Adverse reactions | ANDA090162 199888 0H73WJJ391 |
| Topiramate | TOPIRAMATE | Bryant Ranch Prepack | e9cb3c29-098c-405f-a200-b436ac7fa1a2 | 2024-07-24 | Warnings, Adverse reactions | 199890 0H73WJJ391 |
| Topiramate | TOPIRAMATE | NuCare Pharmaceuticals, Inc. | 4a656a9f-8eb8-69b7-e054-00144ff8d46c | 2024-07-19 | Warnings, Adverse reactions | 199889 0H73WJJ391 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.