Topiramate
- Product NDC
- 12634-453
- 11-digit product format
- 126340453
- Labeler code
- 12634
- Product ID
- 12634-453_35ba1f4c-d50f-0bd5-e054-00144ff88e88
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Topiramate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Apotheca Inc.
- Application
- ANDA090278
- Marketing category
- ANDA
- Marketing start
- 2014-12-15
- Marketing end
- 0000-00-00
- Substance
- TOPIRAMATE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- 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 product | product | 12634-453 | I | Inactivated by FDA | 2026-08-03 | ||
| excluded package | package | 12634-453 | 12634-453-00 | I | Inactivated by FDA | 2026-08-03 | |
| excluded package | package | 12634-453 | 12634-453-01 | I | Inactivated by FDA | 2026-08-03 | |
| excluded package | package | 12634-453 | 12634-453-09 | I | Inactivated by FDA | 2026-08-03 | |
| excluded package | package | 12634-453 | 12634-453-40 | I | Inactivated by FDA | 2026-08-03 | |
| excluded package | package | 12634-453 | 12634-453-42 | I | Inactivated by FDA | 2026-08-03 | |
| excluded package | package | 12634-453 | 12634-453-45 | I | Inactivated by FDA | 2026-08-03 | |
| excluded package | package | 12634-453 | 12634-453-50 | I | Inactivated by FDA | 2026-08-03 | |
| excluded package | package | 12634-453 | 12634-453-52 | I | Inactivated by FDA | 2026-08-03 | |
| excluded package | package | 12634-453 | 12634-453-54 | I | Inactivated by FDA | 2026-08-03 | |
| excluded package | package | 12634-453 | 12634-453-57 | I | Inactivated by FDA | 2026-08-03 | |
| excluded package | package | 12634-453 | 12634-453-59 | I | Inactivated by FDA | 2026-08-03 | |
| excluded package | package | 12634-453 | 12634-453-60 | I | Inactivated by FDA | 2026-08-03 | |
| excluded package | package | 12634-453 | 12634-453-61 | I | Inactivated by FDA | 2026-08-03 | |
| excluded package | package | 12634-453 | 12634-453-63 | I | Inactivated by FDA | 2026-08-03 | |
| excluded package | package | 12634-453 | 12634-453-66 | I | Inactivated by FDA | 2026-08-03 | |
| excluded package | package | 12634-453 | 12634-453-67 | I | Inactivated by FDA | 2026-08-03 | |
| excluded package | package | 12634-453 | 12634-453-69 | I | Inactivated by FDA | 2026-08-03 | |
| excluded package | package | 12634-453 | 12634-453-71 | I | Inactivated by FDA | 2026-08-03 | |
| excluded package | package | 12634-453 | 12634-453-74 | I | Inactivated by FDA | 2026-08-03 | |
| excluded package | package | 12634-453 | 12634-453-78 | I | Inactivated by FDA | 2026-08-03 | |
| excluded package | package | 12634-453 | 12634-453-79 | I | Inactivated by FDA | 2026-08-03 | |
| excluded package | package | 12634-453 | 12634-453-80 | I | Inactivated by FDA | 2026-08-03 | |
| excluded package | package | 12634-453 | 12634-453-81 | I | Inactivated by FDA | 2026-08-03 | |
| excluded package | package | 12634-453 | 12634-453-82 | I | Inactivated by FDA | 2026-08-03 | |
| excluded package | package | 12634-453 | 12634-453-84 | I | Inactivated by FDA | 2026-08-03 | |
| excluded package | package | 12634-453 | 12634-453-85 | I | Inactivated by FDA | 2026-08-03 | |
| excluded package | package | 12634-453 | 12634-453-90 | I | Inactivated by FDA | 2026-08-03 | |
| excluded package | package | 12634-453 | 12634-453-91 | I | Inactivated by FDA | 2026-08-03 | |
| excluded package | package | 12634-453 | 12634-453-92 | I | Inactivated by FDA | 2026-08-03 | |
| excluded package | package | 12634-453 | 12634-453-93 | I | Inactivated by FDA | 2026-08-03 | |
| excluded package | package | 12634-453 | 12634-453-94 | I | Inactivated by FDA | 2026-08-03 | |
| excluded package | package | 12634-453 | 12634-453-95 | I | Inactivated by FDA | 2026-08-03 | |
| excluded package | package | 12634-453 | 12634-453-96 | I | Inactivated by FDA | 2026-08-03 | |
| excluded package | package | 12634-453 | 12634-453-97 | I | Inactivated by FDA | 2026-08-03 | |
| excluded package | package | 12634-453 | 12634-453-98 | I | Inactivated by FDA | 2026-08-03 | |
| excluded package | package | 12634-453 | 12634-453-99 | I | Inactivated by FDA | 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 | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-453-94 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-453-50 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-453-66 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-453-42 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-453-00 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-453-97 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-453-71 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-453-54 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-453-79 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-453-81 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-453-45 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-453-80 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-453-82 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-453-93 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-453-74 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-453-67 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-453-91 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-453-57 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-453-78 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-453-90 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-453-09 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-453-84 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-453-99 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-453-96 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-453-98 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-453-69 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-453-01 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-453-40 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-453-61 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-453-85 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-453-59 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-453-52 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-453-63 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-453-95 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-453-60 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 12634-453-92 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 12634-453-94 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 12634-453-50 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 12634-453-66 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 12634-453-42 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 12634-453-00 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 12634-453-97 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 12634-453-71 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 12634-453-54 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 12634-453-79 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 12634-453-81 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 12634-453-45 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 12634-453-80 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 12634-453-82 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 12634-453-93 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 12634-453-74 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 12634-453-67 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 12634-453-91 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 12634-453-57 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 12634-453-78 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 12634-453-90 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 12634-453-09 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 12634-453-84 | f5e01cc5f278… | a2eaf40c39c3… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A090278-001 | TOPIRAMATE | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | |
| A090278-002 | TOPIRAMATE | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | |
| A090278-003 | TOPIRAMATE | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | |
| A090278-004 | TOPIRAMATE | TOPIRAMATE | 200MG | TABLET / ORAL | 2009-03-27 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A090278-001 | AB |
| A090278-002 | AB |
| A090278-003 | 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 | A090278-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090278-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090278-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090278-004 | TOPIRAMATE | 200MG | TABLET / ORAL | 2009-03-27 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090278-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090278-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090278-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090278-004 | TOPIRAMATE | 200MG | TABLET / ORAL | 2009-03-27 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090278-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090278-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090278-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090278-004 | TOPIRAMATE | 200MG | TABLET / ORAL | 2009-03-27 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090278-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090278-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090278-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090278-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090278-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090278-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090278-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090278-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090278-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090278-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090278-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090278-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090278-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090278-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090278-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090278-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090278-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090278-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090278-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090278-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090278-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090278-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090278-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090278-004 | TOPIRAMATE | 200MG | TABLET / ORAL | AB | 2009-03-27 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090278-001 | TOPIRAMATE | 25MG | TABLET / ORAL | AB | 2009-03-27 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090278-002 | TOPIRAMATE | 50MG | TABLET / ORAL | AB | 2009-03-27 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090278-003 | TOPIRAMATE | 100MG | TABLET / ORAL | AB | 2009-03-27 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090278-004 | 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 | A090278-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090278-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090278-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090278-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090278-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090278-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A090278-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090278-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090278-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090278-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090278-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090278-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090278-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090278-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090278-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090278-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090278-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090278-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090278-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090278-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090278-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090278-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090278-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090278-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090278-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090278-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090278-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090278-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090278-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090278-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090278-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090278-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090278-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A090278-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A090278-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A090278-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A090278-004 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090278-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090278-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090278-003 | AB | 1 | 79d66fd596c7… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e5b1b0ba-27f8-4d5d-8943-8aed080fdedc | Product name | 4 | 20260306 |
| 6c26dd6d-01b5-4a80-b096-b3a6f7ca6077 | Product name | 2 | 20250623 |
| cb966f54-bbf0-40fb-b581-80c6648d510c | Product name | 4 | 20250623 |
| 6e2fb0d7-40d7-e97c-1375-fa022ff20193 | Product name | 4 | 20250305 |
| 3d272a3f-17c0-421d-bc43-3cbdb719258d | Product name | 1 | 20250303 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 12634-453-00 | Topiramate | 10 in 1 BOTTLE | TABLET | 10 | 4 | |
| 12634-453-01 | Topiramate | 100 in 1 BOTTLE | TABLET | 100 | 4 | |
| 12634-453-09 | Topiramate | 35 in 1 BOTTLE | TABLET | 35 | 4 | |
| 12634-453-40 | Topiramate | 40 in 1 BOTTLE | TABLET | 40 | 4 | |
| 12634-453-42 | Topiramate | 42 in 1 BOTTLE | TABLET | 42 | 4 | |
| 12634-453-45 | Topiramate | 45 in 1 BOTTLE | TABLET | 45 | 4 | |
| 12634-453-50 | Topiramate | 50 in 1 BOTTLE | TABLET | 50 | 4 | |
| 12634-453-52 | Topiramate | 12 in 1 BLISTER PACK | TABLET | 12 | 4 | |
| 12634-453-54 | Topiramate | 14 in 1 BLISTER PACK | TABLET | 14 | 4 | |
| 12634-453-57 | Topiramate | 20 in 1 BLISTER PACK | TABLET | 20 | 4 | |
| 12634-453-59 | Topiramate | 30 in 1 BLISTER PACK | TABLET | 30 | 4 | |
| 12634-453-60 | Topiramate | 60 in 1 BOTTLE | TABLET | 60 | 4 | |
| 12634-453-61 | Topiramate | 10 in 1 BLISTER PACK | TABLET | 10 | 4 | |
| 12634-453-63 | Topiramate | 3 in 1 BOTTLE | TABLET | 3 | 4 | |
| 12634-453-66 | Topiramate | 6 in 1 BLISTER PACK | TABLET | 6 | 4 | |
| 12634-453-67 | Topiramate | 7 in 1 BLISTER PACK | TABLET | 7 | 4 | |
| 12634-453-69 | Topiramate | 9 in 1 BLISTER PACK | TABLET | 9 | 4 | |
| 12634-453-71 | Topiramate | 30 in 1 BOTTLE | TABLET | 30 | 4 | |
| 12634-453-74 | Topiramate | 24 in 1 BOTTLE | TABLET | 24 | 4 | |
| 12634-453-78 | Topiramate | 28 in 1 BOTTLE | TABLET | 28 | 4 | |
| 12634-453-79 | Topiramate | 25 in 1 BOTTLE | TABLET | 25 | 4 | |
| 12634-453-80 | Topiramate | 20 in 1 BOTTLE | TABLET | 20 | 4 | |
| 12634-453-81 | Topiramate | 21 in 1 BOTTLE | TABLET | 21 | 4 | |
| 12634-453-82 | Topiramate | 12 in 1 BOTTLE | TABLET | 12 | 4 | |
| 12634-453-84 | Topiramate | 14 in 1 BOTTLE | TABLET | 14 | 4 | |
| 12634-453-85 | Topiramate | 15 in 1 BOTTLE | TABLET | 15 | 4 | |
| 12634-453-90 | Topiramate | 90 in 1 BOTTLE | TABLET | 90 | 4 | |
| 12634-453-91 | Topiramate | 1 in 1 BLISTER PACK | TABLET | 1 | 4 | |
| 12634-453-92 | Topiramate | 2 in 1 BOTTLE | TABLET | 2 | 4 | |
| 12634-453-93 | Topiramate | 3 in 1 BOTTLE | TABLET | 3 | 4 | |
| 12634-453-94 | Topiramate | 4 in 1 BOTTLE | TABLET | 4 | 4 | |
| 12634-453-95 | Topiramate | 5 in 1 BOTTLE | TABLET | 5 | 4 | |
| 12634-453-96 | Topiramate | 6 in 1 BOTTLE | TABLET | 6 | 4 | |
| 12634-453-97 | Topiramate | 7 in 1 BOTTLE | TABLET | 7 | 4 | |
| 12634-453-98 | Topiramate | 8 in 1 BOTTLE | TABLET | 8 | 4 | |
| 12634-453-99 | Topiramate | 9 in 1 BOTTLE | TABLET | 9 | 4 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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. | e846124d-e9e6-42c7-83f1-5df170d3f70b | 2026-07-07 | Warnings, Adverse reactions | 090278 ANDA090278 |
| Topiramate | TOPIRAMATE | Bryant Ranch Prepack | 47ef2964-3a41-4bfd-86fb-d44560b9961f | 2026-06-24 | Warnings, Adverse reactions | 090278 ANDA090278 |
| Topiramate | TOPIRAMATE | Bryant Ranch Prepack | 484c132f-3d3d-4218-b22f-82e9b56cc2f4 | 2026-06-24 | Warnings, Adverse reactions | 090278 ANDA090278 |
| Topiramate | TOPIRAMATE | PD-Rx Pharmaceuticals, Inc. | 1b847969-2124-4350-94b0-ef5ba707673b | 2026-06-08 | Warnings, Adverse reactions | 090278 ANDA090278 |
| Topiramate | TOPIRAMATE | PD-Rx Pharmaceuticals, Inc. | 021005ab-6a00-40d8-9aee-20c91613b4d5 | 2026-06-08 | Warnings, Adverse reactions | 090278 ANDA090278 |
| Topiramate | TOPIRAMATE | Sun Pharmaceutical Industries, Inc. | 3c909a53-ae66-4b28-a741-b60bb25a69cf | 2026-06-01 | Warnings, Adverse reactions | 090278 ANDA090278 |
| Topiramate | TOPIRAMATE | Bryant Ranch Prepack | 61390be3-7553-4cb5-b5da-7571ed7d4b17 | 2024-08-20 | Warnings, Adverse reactions | 090278 ANDA090278 |
| Topiramate | TOPIRAMATE | Bryant Ranch Prepack | ffaacad8-4594-45a8-b292-02a84cd0c35b | 2024-08-20 | Warnings, Adverse reactions | 090278 ANDA090278 |
| Topiramate | TOPIRAMATE | NuCare Pharmaceuticals,Inc. | 9ddb8451-a455-87ec-e053-2995a90a5e5e | 2024-06-20 | Warnings, Adverse reactions | 090278 ANDA090278 |
| Topiramate | TOPIRAMATE | Proficient Rx LP | 8bd03bb2-3b9b-4707-a9a4-5618ddc3832f | 2023-07-01 | Warnings, Adverse reactions | 090278 ANDA090278 |
| TOPIRAMATE | TOPIRAMATE | Proficient Rx LP | a30c583a-4b0a-43a6-ae76-19b1a5e916ca | 2022-10-01 | Warnings, Adverse reactions | 090278 ANDA090278 |
| Topiramate | TOPIRAMATE | Proficient Rx LP | e382a731-ef73-4990-bc74-ffc3a91ff3ba | 2022-06-01 | Warnings, Adverse reactions | 090278 ANDA090278 |
| Topiramate | TOPIRAMATE | Proficient Rx LP | 7d6752ce-7a56-4b04-ab15-cbd40aa5cc94 | 2019-11-01 | Warnings, Adverse reactions | 090278 ANDA090278 |
| Topiramate | TOPIRAMATE | Sun Pharmaceutical Industries, Inc. | 2d9513e0-2fb8-46c9-bbd6-b03efd31c3ef | 2018-11-01 | Warnings, Adverse reactions | 090278 ANDA090278 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 151226 | topiramate 50 MG Oral Tablet | PSN | 3ac13777-45fb-45c2-84b8-d56aad796140 | 4 |
| 151226 | topiramate 50 MG Oral Tablet | SCD | 3ac13777-45fb-45c2-84b8-d56aad796140 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 12634-453-00 | 12634045300 | 10 in 1 BOTTLE | Historical |
| 12634-453-01 | 12634045301 | 100 in 1 BOTTLE | Historical |
| 12634-453-09 | 12634045309 | 35 in 1 BOTTLE | Historical |
| 12634-453-40 | 12634045340 | 40 in 1 BOTTLE | Historical |
| 12634-453-42 | 12634045342 | 42 in 1 BOTTLE | Historical |
| 12634-453-45 | 12634045345 | 45 in 1 BOTTLE | Historical |
| 12634-453-50 | 12634045350 | 50 in 1 BOTTLE | Historical |
| 12634-453-52 | 12634045352 | 12 in 1 BLISTER PACK | Historical |
| 12634-453-54 | 12634045354 | 14 in 1 BLISTER PACK | Historical |
| 12634-453-57 | 12634045357 | 20 in 1 BLISTER PACK | Historical |
| 12634-453-59 | 12634045359 | 30 in 1 BLISTER PACK | Historical |
| 12634-453-60 | 12634045360 | 60 in 1 BOTTLE | Historical |
| 12634-453-61 | 12634045361 | 10 in 1 BLISTER PACK | Historical |
| 12634-453-63 | 12634045363 | 3 in 1 BOTTLE | Historical |
| 12634-453-66 | 12634045366 | 6 in 1 BLISTER PACK | Historical |
| 12634-453-67 | 12634045367 | 7 in 1 BLISTER PACK | Historical |
| 12634-453-69 | 12634045369 | 9 in 1 BLISTER PACK | Historical |
| 12634-453-71 | 12634045371 | 30 in 1 BOTTLE | Historical |
| 12634-453-74 | 12634045374 | 24 in 1 BOTTLE | Historical |
| 12634-453-78 | 12634045378 | 28 in 1 BOTTLE | Historical |
| 12634-453-79 | 12634045379 | 25 in 1 BOTTLE | Historical |
| 12634-453-80 | 12634045380 | 20 in 1 BOTTLE | Historical |
| 12634-453-81 | 12634045381 | 21 in 1 BOTTLE | Historical |
| 12634-453-82 | 12634045382 | 12 in 1 BOTTLE | Historical |
| 12634-453-84 | 12634045384 | 14 in 1 BOTTLE | Historical |
| 12634-453-85 | 12634045385 | 15 in 1 BOTTLE | Historical |
| 12634-453-90 | 12634045390 | 90 in 1 BOTTLE | Historical |
| 12634-453-91 | 12634045391 | 1 in 1 BLISTER PACK | Historical |
| 12634-453-92 | 12634045392 | 2 in 1 BOTTLE | Historical |
| 12634-453-93 | 12634045393 | 3 in 1 BOTTLE | Historical |
| 12634-453-94 | 12634045394 | 4 in 1 BOTTLE | Historical |
| 12634-453-95 | 12634045395 | 5 in 1 BOTTLE | Historical |
| 12634-453-96 | 12634045396 | 6 in 1 BOTTLE | Historical |
| 12634-453-97 | 12634045397 | 7 in 1 BOTTLE | Historical |
| 12634-453-98 | 12634045398 | 8 in 1 BOTTLE | Historical |
| 12634-453-99 | 12634045399 | 9 in 1 BOTTLE | Historical |