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 | A-S Medication Solutions | c6918801-f22c-4ba4-a396-da484d4334ca | 2025-11-07 | Warnings, Adverse reactions | ANDA090162 151226 0H73WJJ391 |
| Topiramate | TOPIRAMATE | NCS HealthCare of KY, LLC dba Vangard Labs | 444464fb-6a95-4e10-99a7-fdbc7dbb4c48 | 2025-10-31 | Warnings, Adverse reactions | 151226 199889 199888 0H73WJJ391 |
| Topiramate | TOPIRAMATE | American Health Packaging | 1af94c80-2b17-409a-98f6-ce00f942351d | 2025-09-30 | Warnings, Adverse reactions | 199890 151226 199889 199888 0H73WJJ391 |
| topiramate | TOPIRAMATE | Major Pharmaceuticals | 6fb00bd8-c49e-46ef-9d6b-1b602e1d11d8 | 2025-08-25 | Warnings, Adverse reactions | 199889 199888 0H73WJJ391 |
| topiramate | TOPIRAMATE | A-S Medication Solutions | 674c2c2e-014a-43a1-91a7-7214ffc4b1d7 | 2025-08-13 | Warnings, Adverse reactions | 199889 0H73WJJ391 |
| Topiramate | TOPIRAMATE | NuCare Pharmaceuticals, Inc. | 490f109f-30cb-0790-e054-00144ff88e88 | 2025-07-24 | Warnings, Adverse reactions | 199888 0H73WJJ391 |
| Topiramate | TOPIRAMATE | PD-Rx Pharmaceuticals, Inc. | 9e516204-8f39-43c9-9f7e-d9777586f321 | 2025-07-15 | Warnings, Adverse reactions | 199889 0H73WJJ391 |
| Topiramate | TOPIRAMATE | PD-Rx Pharmaceuticals, Inc. | e39d2549-b489-426d-b576-741537e112e7 | 2025-07-15 | Warnings, Adverse reactions | 151226 0H73WJJ391 |
| TOPIRAMATE | TOPIRAMATE | XLCare Pharmaceuticals, Inc. | 546103e1-ea6e-466b-b0de-b1ff8c494512 | 2025-07-02 | Warnings, Adverse reactions | 199890 151226 199889 199888 0H73WJJ391 |
| Topiramate | TOPIRAMATE | A-S Medication Solutions | f16b14a2-297f-4adb-8d7a-5f43785faef7 | 2025-06-09 | Warnings, Adverse reactions | 151226 199889 0H73WJJ391 |
| TOPIRAMATE | TOPIRAMATE | Camber Pharmaceuticals, Inc. | cefbc5f4-ef5f-4732-ab96-a69a183f0b6b | 2025-05-22 | Warnings, Adverse reactions | 199890 151226 199889 199888 0H73WJJ391 |
| topiramate | TOPIRAMATE | Bryant Ranch Prepack | 49701840-5a32-4ac1-8b07-5c61decacb95 | 2025-05-01 | Warnings, Adverse reactions | ANDA090162 199888 0H73WJJ391 |
| topiramate | TOPIRAMATE | Bryant Ranch Prepack | bf732c34-9078-496a-8093-f68594e76fcb | 2025-05-01 | Warnings, Adverse reactions | ANDA090162 151226 0H73WJJ391 |
| topiramate | TOPIRAMATE | Bryant Ranch Prepack | 02cac021-e135-483f-bb5d-f3696eef0682 | 2025-05-01 | Warnings, Adverse reactions | ANDA090162 199889 0H73WJJ391 |
| topiramate | TOPIRAMATE | Bryant Ranch Prepack | c320999e-b940-44d8-bf31-2fb78835ac2d | 2025-05-01 | Warnings, Adverse reactions | ANDA090162 199890 0H73WJJ391 |
| Topiramate | TOPIRAMATE | A-S Medication Solutions | ea0bcab1-cfe1-491c-875e-8c865449557e | 2025-04-29 | Warnings, Adverse reactions | 151226 0H73WJJ391 |
| topiramate | TOPIRAMATE | Bryant Ranch Prepack | 073d075d-d019-4834-b55d-9b9587914975 | 2025-04-16 | Warnings, Adverse reactions | ANDA090162 151226 0H73WJJ391 |
| Topiramate | TOPIRAMATE | Cipla USA Inc. | 4087eb3c-96e9-4d0a-b80b-663e1c86d256 | 2025-04-14 | Warnings, Adverse reactions | 199890 151226 199889 199888 0H73WJJ391 |
| Topiramate | TOPIRAMATE | EXELAN PHARMACEUTICALS INC. | 690baf58-1ec9-463e-99b7-d601362ea56b | 2025-04-14 | Warnings, Adverse reactions | 199890 151226 199889 199888 0H73WJJ391 |
| Topiramate | TOPIRAMATE | Cipla USA Inc. | ca4ec248-285d-4066-8f89-5ed0c538c4c9 | 2025-04-09 | Warnings, Adverse reactions | 199890 151226 199889 199888 0H73WJJ391 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.