topiramate
- Product NDC
- 50090-3926
- Requested package NDC
- 50090-3926-0
- 11-digit product format
- 500903926
- Labeler code
- 50090
- Product ID
- 50090-3926_fe5a34c2-c3c9-42a4-89a1-9e4905fd81bc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- topiramate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA078235
- Marketing category
- ANDA
- Marketing start
- 2009-03-27
- Marketing end
- 0000-00-00
- Substance
- TOPIRAMATE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 50090-3926 | 50090-3926-0 | D | Discontinued by firm | 2026-08-03 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 50090-3926 | 50090-3926-0 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 50090-3926 | 50090-3926-0 | D | Discontinued by firm | excluded / ndc_excluded.zip | f5e01cc5f278… | a2eaf40c39c3… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078235-001 | TOPIRAMATE | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | |
| A078235-002 | TOPIRAMATE | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | |
| A078235-003 | TOPIRAMATE | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | |
| A078235-004 | TOPIRAMATE | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078235-001 | AB |
| A078235-002 | AB |
| A078235-003 | AB |
| A078235-004 | AB |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A078235-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078235-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078235-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078235-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078235-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078235-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078235-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078235-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078235-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078235-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078235-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078235-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078235-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078235-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078235-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078235-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078235-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078235-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078235-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078235-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078235-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078235-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078235-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078235-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078235-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078235-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078235-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078235-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078235-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078235-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078235-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078235-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078235-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078235-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078235-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078235-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078235-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078235-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078235-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078235-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A078235-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078235-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078235-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078235-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078235-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078235-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078235-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078235-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078235-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078235-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078235-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078235-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078235-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078235-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078235-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078235-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078235-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078235-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078235-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078235-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078235-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078235-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078235-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078235-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078235-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078235-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078235-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078235-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078235-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078235-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078235-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078235-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078235-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078235-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078235-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078235-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078235-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078235-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078235-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078235-004 | AB | 1 | d06236e962d9… |
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. | 7e0834ee-920b-496f-954d-f9d81c3ba2d6 | 2026-07-17 | Warnings, Adverse reactions | 078235 ANDA078235 |
| topiramate | TOPIRAMATE | REMEDYREPACK INC. | 0366164b-1846-443d-9564-dbe52d8d9b65 | 2026-07-08 | Warnings, Adverse reactions | 078235 ANDA078235 |
| topiramate | TOPIRAMATE | St. Mary's Medical Park Pharmacy | 92637f92-9d7c-c246-e053-2995a90a0347 | 2026-06-26 | Warnings, Adverse reactions | 078235 ANDA078235 |
| topiramate | TOPIRAMATE | St. Mary's Medical Park Pharmacy | 9221403c-467f-738e-e053-2995a90ac8fd | 2026-06-26 | Warnings, Adverse reactions | 078235 ANDA078235 |
| topiramate | TOPIRAMATE | Bryant Ranch Prepack | 8abe45eb-cc75-4625-ae3d-5b2a038c4907 | 2026-06-24 | Warnings, Adverse reactions | 078235 ANDA078235 |
| topiramate | TOPIRAMATE | Bryant Ranch Prepack | bffcd213-4f09-4a5b-8ccb-591a68be402b | 2026-06-24 | Warnings, Adverse reactions | 078235 ANDA078235 |
| topiramate | TOPIRAMATE | Bryant Ranch Prepack | 57462baf-2f32-4bde-9627-2214c8af9370 | 2026-06-24 | Warnings, Adverse reactions | 078235 ANDA078235 |
| topiramate | TOPIRAMATE | Bryant Ranch Prepack | ca9ce6c1-5a60-467a-9ad5-acc7a9f8ca15 | 2026-06-24 | Warnings, Adverse reactions | 078235 ANDA078235 |
| topiramate | TOPIRAMATE | Coupler LLC | 5461f33d-eaef-dce3-e063-6294a90aeff8 | 2026-06-16 | Warnings, Adverse reactions | 078235 ANDA078235 |
| topiramate | TOPIRAMATE | AvPAK | 53c3f980-f05b-c671-e063-6294a90a77d5 | 2026-06-09 | Warnings, Adverse reactions | 078235 ANDA078235 |
| topiramate | TOPIRAMATE | REMEDYREPACK INC. | 6f461f84-bfad-44fa-a2bd-5ea1566444b5 | 2026-05-21 | Warnings, Adverse reactions | 078235 ANDA078235 |
| topiramate | TOPIRAMATE | REMEDYREPACK INC. | b7539f52-06e9-4663-b401-92f5f83653cc | 2026-05-21 | Warnings, Adverse reactions | 078235 ANDA078235 |
| topiramate | TOPIRAMATE | REMEDYREPACK INC. | 5ce65b7f-9215-47a8-a784-f87a810bd7e4 | 2026-05-19 | Warnings, Adverse reactions | 078235 ANDA078235 |
| topiramate | TOPIRAMATE | REMEDYREPACK INC. | 2f5b1b0b-fd8a-4c4e-a85a-519ca841a0db | 2026-05-19 | Warnings, Adverse reactions | 078235 ANDA078235 |
| topiramate | TOPIRAMATE | REMEDYREPACK INC. | 149d20de-f262-4567-aa97-d4d28a1653cb | 2026-04-30 | Warnings, Adverse reactions | 078235 ANDA078235 |
| topiramate | TOPIRAMATE | Quallent Pharmaceuticals Health LLC | 9dae6824-6913-42de-b98a-cdcb0d3b4a46 | 2026-04-25 | Warnings, Adverse reactions | 078235 ANDA078235 |
| topiramate | TOPIRAMATE | Zydus Pharmaceuticals USA Inc. | 67dcdd6e-48bc-418e-a887-805929d83ce0 | 2026-04-15 | Warnings, Adverse reactions | 078235 ANDA078235 |
| topiramate | TOPIRAMATE | Northwind Health Company, LLC | afd4c2b9-b80c-b43a-e053-2995a90ac923 | 2026-01-01 | Warnings, Adverse reactions | 078235 ANDA078235 |
| topiramate | TOPIRAMATE | Northwind Health Company, LLC | f3321dc5-0fb7-0d12-e053-2a95a90a9694 | 2026-01-01 | Warnings, Adverse reactions | 078235 ANDA078235 |
| topiramate | TOPIRAMATE | Northwind Health Company, LLC | ffd7be08-050e-dfcb-e053-6394a90ad286 | 2026-01-01 | Warnings, Adverse reactions | 078235 ANDA078235 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-3926-0 | EA - Each | 50090-3926 | f4df71af-84ff-41c8-b1d1-5fa28df16bab | 1 | 2021-12-08 |
| 50090-3926-1 | EA - Each | 50090-3926 | a9fc12de-b752-4935-a9bf-c24987089266 | 1 | 2021-12-08 |
| 50090-3926-2 | EA - Each | 50090-3926 | 82965331-6f40-46be-8009-3e84715dc425 | 1 | 2021-12-08 |
| 50090-3926-3 | EA - Each | 50090-3926 | ab5eaed9-c79d-49c7-a7a0-8a3bda008a46 | 1 | 2023-01-09 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50090-3926 | TOPIRAMATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] | 14 | Legacy NDC | 20231213_88156c4e-bc29-497d-8110-e59d800ff38a.zip |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 50090-3926-0 | 50090392600 | 60 TABLET, FILM COATED in 1 BOTTLE (50090-3926-0) | 2018-12-07 | 0000-00-00 | No | No | Current |