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 | Proficient Rx LP | 5d9b2c1d-565e-4c43-96ef-e5cd2593d0a8 | 2020-09-01 | Warnings, Adverse reactions | 151226 199889 0H73WJJ391 |
| topiramate | TOPIRAMATE | Proficient Rx LP | cc918c0d-2b1e-4fa0-b4d3-9dbc28718018 | 2020-02-01 | Warnings, Adverse reactions | ANDA090162 151226 0H73WJJ391 |
| topiramate | TOPIRAMATE | Proficient Rx LP | 584e16c5-5ffb-4bfc-ba80-4340afd25e8e | 2020-01-01 | Warnings, Adverse reactions | ANDA090162 199889 0H73WJJ391 |
| Topiramate | TOPIRAMATE | Proficient Rx LP | 7d6752ce-7a56-4b04-ab15-cbd40aa5cc94 | 2019-11-01 | Warnings, Adverse reactions | 199889 0H73WJJ391 |
| Topiramate | TOPIRAMATE | Proficient Rx LP | efc0d85e-fddc-4122-85b2-da2d2cb2f9d8 | 2019-11-01 | Warnings, Adverse reactions | 199890 0H73WJJ391 |
| topiramate | TOPIRAMATE | Proficient Rx LP | 2d6d236b-9808-4e18-b521-e7435d1fd5cc | 2019-10-01 | Warnings, Adverse reactions | ANDA090162 199888 0H73WJJ391 |
| Topiramate | TOPIRAMATE | Sun Pharmaceutical Industries, Inc. | 2d9513e0-2fb8-46c9-bbd6-b03efd31c3ef | 2018-11-01 | Warnings, Adverse reactions | 0H73WJJ391 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.