Topiramate
- Product NDC
- 0480-2356
- Requested package NDC
- 0480-2356-99
- 11-digit product format
- 004802356
- Labeler code
- 0480
- Product ID
- 0480-2356_38168585-df97-4809-8f00-a61122c7259f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Topiramate
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals, Inc.
- Application
- ANDA206210
- Marketing category
- ANDA
- Marketing start
- 2023-05-03
- Substance
- TOPIRAMATE
- Active strength
- 25 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
- 2027-12-31
- Current FDA listing
- Yes
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| unfinished package | package | 0480-2356 | 0480-2356-99 | UNFINISHED | Active or certified unfinished drug listing | 2026-08-03 |
Observed NDC auxiliary status history#
Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.
| Captured / source date | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-12-14 21:27 UTC · source 2025-12-05 | unfinished package | package | 0480-2356 | 0480-2356-99 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | a6255e0c9aa5… | a0211a219f2e… | |
| 2025-08-26 23:59 UTC · source 2025-08-26 | unfinished package | package | 0480-2356 | 0480-2356-99 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 1d862106b807… | 00c93037cd84… | |
| 2025-05-15 14:59 UTC · source 2025-05-14 | unfinished package | package | 0480-2356 | 0480-2356-99 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 390b4c401c3f… | 2c692c2daee3… | |
| 2025-04-01 07:37 UTC · source 2025-03-31 | unfinished package | package | 0480-2356 | 0480-2356-99 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | e30019b0c005… | a3f0b14938b7… | |
| 2025-03-01 13:19 UTC · source 2025-02-28 | unfinished package | package | 0480-2356 | 0480-2356-99 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | bbbc9f937eca… | 946b9c97cf81… | |
| 2025-02-27 05:24 UTC · source 2025-02-26 | unfinished package | package | 0480-2356 | 0480-2356-99 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | f268b84574a6… | 26285f5ac5df… | |
| 2025-02-01 13:13 UTC · source 2025-01-31 | unfinished package | package | 0480-2356 | 0480-2356-99 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | f764e8902f78… | 92046438deef… | |
| 2025-01-20 13:05 UTC · source 2025-01-17 | unfinished package | package | 0480-2356 | 0480-2356-99 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 68b1e3bced9e… | 98a755eb8bc6… | |
| 2024-11-29 20:42 UTC · source 2024-11-29 | unfinished package | package | 0480-2356 | 0480-2356-99 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 05c55d027831… | ca05dca9dc4c… | |
| 2024-11-09 02:36 UTC · source 2024-11-08 | unfinished package | package | 0480-2356 | 0480-2356-99 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 48b4f40e6753… | c7c7a00d2afa… | |
| 2024-10-09 02:27 UTC · source 2024-10-08 | unfinished package | package | 0480-2356 | 0480-2356-99 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 27f29a85d7e4… | 1372111e901f… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | unfinished package | package | 0480-2356 | 0480-2356-99 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 8d62ce987f31… | 9fe9ef23e30d… | |
| 2024-05-28 21:11 UTC · source 2024-05-28 | unfinished package | package | 0480-2356 | 0480-2356-99 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | d1e113ab4d42… | 063ee3eb0a1d… | |
| 2024-05-15 03:51 UTC · source 2024-05-14 | unfinished package | package | 0480-2356 | 0480-2356-99 | UNFINISHED | Active or certified unfinished drug listing | unfinished / ndc_unfinished.zip | 50b4072663b7… | eae3003ed65e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A206210-001 | TOPIRAMATE | TOPIRAMATE | 25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-03-10 | |
| A206210-002 | TOPIRAMATE | TOPIRAMATE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-03-10 | |
| A206210-003 | TOPIRAMATE | TOPIRAMATE | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-03-10 | |
| A206210-004 | TOPIRAMATE | TOPIRAMATE | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-03-10 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A206210-001 | AB1 |
| A206210-002 | AB1 |
| A206210-003 | AB1 |
| A206210-004 | AB1 |
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 | A206210-001 | TOPIRAMATE | 25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-03-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A206210-002 | TOPIRAMATE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-03-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A206210-003 | TOPIRAMATE | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-03-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A206210-004 | TOPIRAMATE | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-03-10 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206210-001 | TOPIRAMATE | 25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-03-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206210-002 | TOPIRAMATE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-03-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206210-003 | TOPIRAMATE | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-03-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206210-004 | TOPIRAMATE | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-03-10 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206210-001 | TOPIRAMATE | 25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-03-10 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206210-002 | TOPIRAMATE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-03-10 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206210-003 | TOPIRAMATE | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-03-10 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206210-004 | TOPIRAMATE | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-03-10 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206210-001 | TOPIRAMATE | 25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-03-10 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206210-002 | TOPIRAMATE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-03-10 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206210-003 | TOPIRAMATE | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-03-10 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206210-004 | TOPIRAMATE | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-03-10 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206210-001 | TOPIRAMATE | 25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-03-10 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206210-002 | TOPIRAMATE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-03-10 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206210-003 | TOPIRAMATE | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-03-10 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206210-004 | TOPIRAMATE | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-03-10 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206210-001 | TOPIRAMATE | 25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-03-10 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206210-002 | TOPIRAMATE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-03-10 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206210-003 | TOPIRAMATE | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-03-10 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206210-004 | TOPIRAMATE | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-03-10 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206210-001 | TOPIRAMATE | 25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-03-10 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206210-002 | TOPIRAMATE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-03-10 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206210-003 | TOPIRAMATE | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-03-10 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206210-004 | TOPIRAMATE | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-03-10 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206210-001 | TOPIRAMATE | 25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-03-10 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206210-002 | TOPIRAMATE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-03-10 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206210-003 | TOPIRAMATE | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-03-10 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206210-004 | TOPIRAMATE | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-03-10 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206210-001 | TOPIRAMATE | 25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-03-10 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206210-002 | TOPIRAMATE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-03-10 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206210-003 | TOPIRAMATE | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-03-10 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206210-004 | TOPIRAMATE | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-03-10 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A206210-001 | TOPIRAMATE | 25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-03-10 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A206210-002 | TOPIRAMATE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-03-10 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A206210-003 | TOPIRAMATE | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-03-10 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A206210-004 | TOPIRAMATE | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2023-03-10 | 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 | A206210-001 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A206210-002 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A206210-003 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A206210-004 | AB1 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206210-001 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206210-002 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206210-003 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206210-004 | AB1 | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A206210-001 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A206210-002 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A206210-003 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A206210-004 | AB1 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206210-001 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206210-002 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206210-003 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206210-004 | AB1 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206210-001 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206210-002 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206210-003 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206210-004 | AB1 | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206210-001 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206210-002 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206210-003 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206210-004 | AB1 | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206210-001 | AB1 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206210-002 | AB1 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206210-003 | AB1 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206210-004 | AB1 | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206210-001 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206210-002 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206210-003 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206210-004 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206210-001 | AB1 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206210-002 | AB1 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206210-003 | AB1 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206210-004 | AB1 | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A206210-001 | AB1 | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A206210-002 | AB1 | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A206210-003 | AB1 | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A206210-004 | AB1 | 1 | d06236e962d9… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Topiramate | TOPIRAMATE | Teva Pharmaceuticals, Inc. | 4f20155f-05b9-40ec-af34-3b58aa8d60d4 | 2026-04-28 | Warnings, Adverse reactions | 206210 ANDA206210 0480-2356 |
| Topiramate | TOPIRAMATE | AvKARE | 25b377f7-ea89-fb56-e063-6394a90a239d | 2026-01-19 | Warnings, Adverse reactions | 206210 ANDA206210 |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Topiramate
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| TOPIRAMATE | 25 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 0H73WJJ391 | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4f20155f-05b9-40ec-af34-3b58aa8d60d4 | Available on FDA.report |
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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0480-2356-01 | Topiramate | 100 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 100 | 7 | |
| 0480-2356-56 | Topiramate | 30 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 30 | 7 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0480-2356-01 | EA - Each | 0480-2356 | 3d35c3ea-24af-424c-9832-d4171baf50a6 | 1 | 2023-06-06 |
| 0480-2356-56 | EA - Each | 0480-2356 | 8ea69f50-c510-4583-8397-70718c127391 | 1 | 2023-06-06 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1437283 | topiramate 100 MG 24HR Extended Release Oral Capsule | PSN | 4f20155f-05b9-40ec-af34-3b58aa8d60d4 | 7 |
| 1437288 | topiramate 200 MG 24HR Extended Release Oral Capsule | PSN | 4f20155f-05b9-40ec-af34-3b58aa8d60d4 | 7 |
| 1437278 | topiramate 25 MG 24HR Extended Release Oral Capsule | PSN | 4f20155f-05b9-40ec-af34-3b58aa8d60d4 | 7 |
| 1436239 | topiramate 50 MG 24HR Extended Release Oral Capsule | PSN | 4f20155f-05b9-40ec-af34-3b58aa8d60d4 | 7 |
| 1437283 | 24 HR topiramate 100 MG Extended Release Oral Capsule | SCD | 4f20155f-05b9-40ec-af34-3b58aa8d60d4 | 7 |
| 1437288 | 24 HR topiramate 200 MG Extended Release Oral Capsule | SCD | 4f20155f-05b9-40ec-af34-3b58aa8d60d4 | 7 |
| 1437278 | 24 HR topiramate 25 MG Extended Release Oral Capsule | SCD | 4f20155f-05b9-40ec-af34-3b58aa8d60d4 | 7 |
| 1436239 | 24 HR topiramate 50 MG Extended Release Oral Capsule | SCD | 4f20155f-05b9-40ec-af34-3b58aa8d60d4 | 7 |
| 1437283 | topiramate 100 MG 24 HR Extended Release Oral Capsule | SY | 4f20155f-05b9-40ec-af34-3b58aa8d60d4 | 7 |
| 1437288 | topiramate 200 MG 24 HR Extended Release Oral Capsule | SY | 4f20155f-05b9-40ec-af34-3b58aa8d60d4 | 7 |
| 1437278 | topiramate 25 MG 24 HR Extended Release Oral Capsule | SY | 4f20155f-05b9-40ec-af34-3b58aa8d60d4 | 7 |
| 1436239 | topiramate 50 MG 24 HR Extended Release Oral Capsule | SY | 4f20155f-05b9-40ec-af34-3b58aa8d60d4 | 7 |
| 1437283 | topiramate 100 MG 24HR Extended Release Oral Capsule | PSN | 25b377f7-ea89-fb56-e063-6394a90a239d | 2 |
| 1437288 | topiramate 200 MG 24HR Extended Release Oral Capsule | PSN | 25b377f7-ea89-fb56-e063-6394a90a239d | 2 |
| 1437278 | topiramate 25 MG 24HR Extended Release Oral Capsule | PSN | 25b377f7-ea89-fb56-e063-6394a90a239d | 2 |
| 1436239 | topiramate 50 MG 24HR Extended Release Oral Capsule | PSN | 25b377f7-ea89-fb56-e063-6394a90a239d | 2 |
| 1437283 | 24 HR topiramate 100 MG Extended Release Oral Capsule | SCD | 25b377f7-ea89-fb56-e063-6394a90a239d | 2 |
| 1437288 | 24 HR topiramate 200 MG Extended Release Oral Capsule | SCD | 25b377f7-ea89-fb56-e063-6394a90a239d | 2 |
| 1437278 | 24 HR topiramate 25 MG Extended Release Oral Capsule | SCD | 25b377f7-ea89-fb56-e063-6394a90a239d | 2 |
| 1436239 | 24 HR topiramate 50 MG Extended Release Oral Capsule | SCD | 25b377f7-ea89-fb56-e063-6394a90a239d | 2 |
| 1437283 | topiramate 100 MG 24 HR Extended Release Oral Capsule | SY | 25b377f7-ea89-fb56-e063-6394a90a239d | 2 |
| 1437288 | topiramate 200 MG 24 HR Extended Release Oral Capsule | SY | 25b377f7-ea89-fb56-e063-6394a90a239d | 2 |
| 1437278 | topiramate 25 MG 24 HR Extended Release Oral Capsule | SY | 25b377f7-ea89-fb56-e063-6394a90a239d | 2 |
| 1436239 | topiramate 50 MG 24 HR Extended Release Oral Capsule | SY | 25b377f7-ea89-fb56-e063-6394a90a239d | 2 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Status |
|---|---|---|---|---|
| 0480-2356-99 | 00480235699 | 23500 CAPSULE, EXTENDED RELEASE in 1 CONTAINER (0480-2356-99) | 10-MAR-23 | Current |