NDC 80425-0195-02 - 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
- 80425-0195
- Requested NDC
- 80425-0195-02
- Package NDCs from labels
- 80425-0195-2, 80425-0195-3, 80425-0195-02
- 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 |
|---|---|---|---|---|---|---|
| 80425-0195-2 | Topiramate | 60 in 1 BOTTLE | TABLET | 60 | 5 | |
| 80425-0195-3 | Topiramate | 90 in 1 BOTTLE | TABLET | 90 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 80425-0195 | TOPIRAMATE TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20250101_d8dff98f-185e-77ba-e053-2995a90aed2f.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 80425-0195-2 | EA - Each | 80425-0195 | 93ccb419-c341-4c50-99ab-cfb455853905 | 1 | 2023-04-07 |
| 80425-0195-3 | EA - Each | 80425-0195 | 58844c2c-fcbf-48f4-8a0a-e2d76c35ce46 | 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 |
|---|---|---|---|---|---|---|
| Topiramate | TOPIRAMATE | REMEDYREPACK INC. | 3f99b26b-79b9-4efb-aa2c-2868e1e126c8 | 2026-09-04 | Warnings, Adverse reactions | 151226 0H73WJJ391 |
| QUDEXY XR | TOPIRAMATE | Upsher-Smith Laboratories, LLC | 46f54677-3a22-4c38-9b92-923020164e15 | 2026-09-03 | Warnings, Adverse reactions | 0H73WJJ391 |
| topiramate | TOPIRAMATE | REMEDYREPACK INC. | 0c0a6774-e234-47a5-866e-462cfd99744c | 2026-09-01 | Warnings, Adverse reactions | 0H73WJJ391 |
| topiramate | TOPIRAMATE | Coupler LLC | 59f39dea-f29b-d6c6-e063-6294a90a5b74 | 2026-08-26 | Warnings, Adverse reactions | 199889 0H73WJJ391 |
| topiramate | TOPIRAMATE | Coupler LLC | 5826cb22-3559-171b-e063-6394a90ad594 | 2026-08-03 | Warnings, Adverse reactions | 199889 0H73WJJ391 |
| Topiramate | TOPIRAMATE | REMEDYREPACK INC. | 610d4df7-703f-4070-9adc-3e57ca05a2f1 | 2026-07-31 | Warnings, Adverse reactions | 199889 0H73WJJ391 |
| Topiramate | TOPIRAMATE | REMEDYREPACK INC. | c90d81a9-a87b-48b0-8cf1-172b82e30127 | 2026-07-31 | Warnings, Adverse reactions | ANDA076343 199888 0H73WJJ391 |
| Topiramate | TOPIRAMATE | PD-Rx Pharmaceuticals, Inc. | 4833f2e8-16b7-406f-937a-55bc978bf92c | 2026-07-29 | Warnings, Adverse reactions | 151226 0H73WJJ391 |
| Topiramate | TOPIRAMATE | REMEDYREPACK INC. | 44095c2b-2e90-45d2-ab45-d0961c41550d | 2026-07-20 | Warnings, Adverse reactions | ANDA076343 199889 0H73WJJ391 |
| topiramate | TOPIRAMATE | REMEDYREPACK INC. | 7e0834ee-920b-496f-954d-f9d81c3ba2d6 | 2026-07-17 | Warnings, Adverse reactions | 199889 0H73WJJ391 |
| Topiramate | TOPIRAMATE | REMEDYREPACK INC. | b71c09c5-43dd-4d98-9ab6-0b0c99908cac | 2026-07-09 | Warnings, Adverse reactions | ANDA076343 199890 0H73WJJ391 |
| Topiramate | TOPIRAMATE | REMEDYREPACK INC. | f8aaf403-0e15-4bbb-b88b-253d93439688 | 2026-07-09 | Warnings, Adverse reactions | ANDA076343 151226 0H73WJJ391 |
| Topiramate | TOPIRAMATE | Unit Dose Solutions, Inc. | 562f3fec-489b-4662-e063-6294a90a4ea2 | 2026-07-09 | Warnings, Adverse reactions | 199888 0H73WJJ391 |
| topiramate | TOPIRAMATE | REMEDYREPACK INC. | 0366164b-1846-443d-9564-dbe52d8d9b65 | 2026-07-08 | Warnings, Adverse reactions | 199890 0H73WJJ391 |
| Topiramate | TOPIRAMATE | PD-Rx Pharmaceuticals, Inc. | e846124d-e9e6-42c7-83f1-5df170d3f70b | 2026-07-07 | Warnings, Adverse reactions | 199889 0H73WJJ391 |
| Topiramate | TOPIRAMATE | Coupler LLC | 55f2aca4-b961-a746-e063-6294a90ae8ce | 2026-07-06 | Warnings, Adverse reactions | ANDA076343 199889 0H73WJJ391 |
| Topiramate | TOPIRAMATE | REMEDYREPACK INC. | 0cf388dc-d8f1-4478-bf5f-e64638ee5801 | 2026-06-29 | Warnings, Adverse reactions | ANDA076343 199888 0H73WJJ391 |
| topiramate | TOPIRAMATE | St. Mary's Medical Park Pharmacy | 92637f92-9d7c-c246-e053-2995a90a0347 | 2026-06-26 | Warnings, Adverse reactions | 151226 0H73WJJ391 |
| topiramate | TOPIRAMATE | St. Mary's Medical Park Pharmacy | 9221403c-467f-738e-e053-2995a90ac8fd | 2026-06-26 | Warnings, Adverse reactions | 199888 0H73WJJ391 |
| Topiramate | TOPIRAMATE | Bryant Ranch Prepack | 47ef2964-3a41-4bfd-86fb-d44560b9961f | 2026-06-24 | Warnings, Adverse reactions | 199890 0H73WJJ391 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.