NDC 80425-0208-01 - 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
- 80425-0208
- Requested NDC
- 80425-0208-01
- Package NDCs from labels
- 80425-0208-1, 80425-0208-2, 80425-0208-3, 80425-0208-01
- 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 |
|---|---|---|---|---|---|---|
| 80425-0208-1 | Topiramate | 60 in 1 BOTTLE | TABLET | 60 | 3 | |
| 80425-0208-2 | Topiramate | 30 in 1 BOTTLE | TABLET | 30 | 3 | |
| 80425-0208-3 | Topiramate | 90 in 1 BOTTLE | TABLET | 90 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 80425-0208 | TOPIRAMATE TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC] | 3 | Current NDC, Legacy NDC, 3 package rows | 20250101_eca774cf-2e4e-7642-e053-2a95a90a847d.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 80425-0208-1 | EA - Each | 80425-0208 | 51098446-252b-47dd-815c-48f7a3c9f1c4 | 1 | 2023-04-07 |
| 80425-0208-2 | EA - Each | 80425-0208 | f3740312-abf9-4506-b6bf-54643e594011 | 1 | 2023-06-06 |
| 80425-0208-3 | EA - Each | 80425-0208 | f818edb6-3f4d-46b9-8ae8-2ab2543caeca | 1 | 2023-06-06 |
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 | NuCare Pharmaceuticals,Inc. | 9ddb8451-a455-87ec-e053-2995a90a5e5e | 2024-06-20 | Warnings, Adverse reactions | 151226 0H73WJJ391 |
| topiramate | TOPIRAMATE | NuCare Pharmaceuticals,Inc. | 816566bf-b909-606f-e053-2a91aa0ab8c9 | 2024-06-14 | Warnings, Adverse reactions | 151226 0H73WJJ391 |
| topiramate | TOPIRAMATE | NuCare Pharmaceuticals,Inc. | 87dc077b-2c84-522b-e053-2995a90a68bc | 2024-06-14 | Warnings, Adverse reactions | 199889 0H73WJJ391 |
| topiramate | TOPIRAMATE | Advanced Rx of Tennessee, LLC | 1a16d6a9-3dd1-ede8-e063-6294a90afe75 | 2024-06-04 | Warnings, Adverse reactions | 199889 0H73WJJ391 |
| Topiramate | TOPIRAMATE | Bryant Ranch Prepack | 78ef4e4e-d391-4417-952b-06202d5000d8 | 2024-04-05 | Warnings, Adverse reactions | ANDA076343 199889 0H73WJJ391 |
| Topiramate | TOPIRAMATE | Advanced Rx Pharmacy of Tennessee, LLC | 10a9e6fa-4d55-6b5c-e063-6294a90a608c | 2024-02-05 | Warnings, Adverse reactions | ANDA076343 199889 0H73WJJ391 |
| Topiramate | TOPIRAMATE | A-S Medication Solutions | 93da6674-14dc-4c8d-9424-03e4b2b41479 | 2023-12-12 | Warnings, Adverse reactions | ANDA076343 199889 0H73WJJ391 |
| topiramate | TOPIRAMATE | A-S Medication Solutions | f7f2d1bc-9c65-4798-826f-6902b3ec81dc | 2023-11-24 | Warnings, Adverse reactions | 199888 0H73WJJ391 |
| Topiramate | TOPIRAMATE | Zydus Lifesciences Limited | 9a943af0-1c6d-43c2-830a-f303baa16124 | 2023-11-08 | 0H73WJJ391 | |
| Topiramate | TOPIRAMATE | Zydus Lifesciences Limited | 57b5d67b-b29b-4c18-a53d-51d5374f3be3 | 2023-09-28 | 0H73WJJ391 | |
| Topiramate | TOPIRAMATE | Proficient Rx LP | 8bd03bb2-3b9b-4707-a9a4-5618ddc3832f | 2023-07-01 | Warnings, Adverse reactions | 151226 0H73WJJ391 |
| Topiramate | TOPIRAMATE | Proficient Rx LP | 2917ba32-3355-4d64-966a-8518e6fafdbe | 2023-06-01 | Warnings, Adverse reactions | ANDA076343 199888 0H73WJJ391 |
| topiramate | TOPIRAMATE | Proficient Rx LP | 80481455-7ad7-4f44-8113-b8b61d8581a0 | 2022-11-01 | Warnings, Adverse reactions | 199888 0H73WJJ391 |
| TOPIRAMATE | TOPIRAMATE | Proficient Rx LP | a30c583a-4b0a-43a6-ae76-19b1a5e916ca | 2022-10-01 | Warnings, Adverse reactions | 151226 199889 199888 0H73WJJ391 |
| Topiramate | TOPIRAMATE | Asclemed USA, Inc. | 4e476c33-3590-4c6f-981d-915623cdacf0 | 2022-09-09 | Warnings, Adverse reactions | ANDA076343 199890 151226 199889 199888 0H73WJJ391 |
| Topiramate | TOPIRAMATE | Proficient Rx LP | e382a731-ef73-4990-bc74-ffc3a91ff3ba | 2022-06-01 | Warnings, Adverse reactions | 199888 0H73WJJ391 |
| Topiramate | TOPIRAMATE | Proficient Rx LP | 57ac12ed-27f0-4f5c-96ae-a7433714b429 | 2022-05-02 | Warnings, Adverse reactions | ANDA076343 151226 0H73WJJ391 |
| Topiramate | TOPIRAMATE | Aphena Pharma Solutions - Tennessee, LLC | 3b18b43c-0de2-4acf-b0d5-f1b601d496de | 2021-05-03 | Warnings, Adverse reactions | 199890 151226 199889 199888 0H73WJJ391 |
| Topiramate | TOPIRAMATE | Proficient Rx LP | e9c4e279-0ef9-4e96-8741-dfe7556953d9 | 2021-01-01 | Warnings, Adverse reactions | 151226 0H73WJJ391 |
| Topiramate | TOPIRAMATE | Proficient Rx LP | a712d050-d5de-4685-a80a-548ab080fdb7 | 2021-01-01 | Warnings, Adverse reactions | 199888 0H73WJJ391 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.