Topiramate
- Product NDC
- 70518-3460
- Requested package NDC
- 70518-3460-0
- 11-digit product format
- 705183460
- Labeler code
- 70518
- Product ID
- 70518-3460_e4b55905-2c2c-7fdf-e053-2a95a90afd45
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Topiramate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA078462
- Marketing category
- ANDA
- Marketing start
- 2022-07-25
- 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 | 70518-3460 | 70518-3460-0 | 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 | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078462-001 | TOPIRAMATE | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | |
| A078462-002 | TOPIRAMATE | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | |
| A078462-003 | TOPIRAMATE | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | |
| A078462-004 | TOPIRAMATE | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078462-001 | AB |
| A078462-002 | AB |
| A078462-003 | AB |
| A078462-004 | 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 | A078462-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078462-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078462-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078462-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078462-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078462-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078462-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078462-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078462-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078462-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078462-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078462-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078462-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078462-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078462-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078462-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078462-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078462-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078462-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078462-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078462-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078462-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078462-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078462-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078462-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078462-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078462-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078462-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078462-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078462-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078462-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078462-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078462-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078462-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078462-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078462-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078462-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078462-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078462-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078462-004 | 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 | A078462-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078462-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078462-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078462-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078462-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078462-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078462-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078462-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078462-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078462-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078462-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078462-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078462-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078462-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078462-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078462-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078462-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078462-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078462-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078462-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078462-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078462-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078462-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078462-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078462-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078462-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078462-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078462-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078462-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078462-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078462-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078462-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078462-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078462-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078462-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078462-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078462-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078462-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078462-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078462-004 | 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 | PD-Rx Pharmaceuticals, Inc. | 4833f2e8-16b7-406f-937a-55bc978bf92c | 2026-07-29 | Warnings, Adverse reactions | 078462 ANDA078462 |
| Topiramate | TOPIRAMATE | Aurobindo Pharma Limited | 32b48ea0-a215-43b8-83b4-a5435a686d68 | 2026-03-24 | Warnings, Adverse reactions | 078462 ANDA078462 |
| Topiramate | TOPIRAMATE | PD-Rx Pharmaceuticals, Inc. | 5424d59e-74f1-4c3c-b737-79e9776e0b60 | 2026-03-23 | Warnings, Adverse reactions | 078462 ANDA078462 |
| Topiramate | TOPIRAMATE | NCS HealthCare of KY, LLC dba Vangard Labs | 444464fb-6a95-4e10-99a7-fdbc7dbb4c48 | 2025-10-31 | Warnings, Adverse reactions | 078462 ANDA078462 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70518-3460-0 | 70518346000 | 30 POUCH in 1 BOX (70518-3460-0) > 1 TABLET, FILM COATED in 1 POUCH (70518-3460-1) | 30 pouch | 2022-07-25 | 0000-00-00 | No | No | Current |