TOPIRAMATE

Product NDC
13668-033
Requested package NDC
13668-033-31
11-digit product format
136680033
Labeler code
13668
Product ID
13668-033_16ea5453-3213-4fef-9918-92f5c7179798
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
topiramate
Dosage form
TABLET
Route
ORAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA079153
Marketing category
ANDA
Marketing start
2009-03-27
Marketing end
0000-00-00
Substance
TOPIRAMATE
Active strength
100 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
2024-12-31
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.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage13668-03313668-033-31DDiscontinued by firm2026-08-03

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.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A079153-001TOPIRAMATETOPIRAMATE25MGTABLET / ORAL2009-03-27
A079153-002TOPIRAMATETOPIRAMATE50MGTABLET / ORAL2009-03-27
A079153-003TOPIRAMATETOPIRAMATE100MGTABLET / ORAL2009-03-27
A079153-004TOPIRAMATETOPIRAMATE200MGTABLET / ORAL2009-03-27

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.

Product history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A079153-001TOPIRAMATE25MGTABLET / ORAL2009-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079153-002TOPIRAMATE50MGTABLET / ORAL2009-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079153-003TOPIRAMATE100MGTABLET / ORAL2009-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079153-004TOPIRAMATE200MGTABLET / ORAL2009-03-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079153-001TOPIRAMATE25MGTABLET / ORAL2009-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079153-002TOPIRAMATE50MGTABLET / ORAL2009-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079153-003TOPIRAMATE100MGTABLET / ORAL2009-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079153-004TOPIRAMATE200MGTABLET / ORAL2009-03-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A079153-001TOPIRAMATE25MGTABLET / ORAL2009-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079153-002TOPIRAMATE50MGTABLET / ORAL2009-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079153-003TOPIRAMATE100MGTABLET / ORAL2009-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079153-004TOPIRAMATE200MGTABLET / ORAL2009-03-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079153-001TOPIRAMATE25MGTABLET / ORAL2009-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079153-002TOPIRAMATE50MGTABLET / ORAL2009-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079153-003TOPIRAMATE100MGTABLET / ORAL2009-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079153-004TOPIRAMATE200MGTABLET / ORAL2009-03-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079153-001TOPIRAMATE25MGTABLET / ORAL2009-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079153-002TOPIRAMATE50MGTABLET / ORAL2009-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079153-003TOPIRAMATE100MGTABLET / ORAL2009-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079153-004TOPIRAMATE200MGTABLET / ORAL2009-03-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079153-001TOPIRAMATE25MGTABLET / ORAL2009-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079153-002TOPIRAMATE50MGTABLET / ORAL2009-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079153-003TOPIRAMATE100MGTABLET / ORAL2009-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079153-004TOPIRAMATE200MGTABLET / ORAL2009-03-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079153-001TOPIRAMATE25MGTABLET / ORAL2009-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079153-002TOPIRAMATE50MGTABLET / ORAL2009-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079153-003TOPIRAMATE100MGTABLET / ORAL2009-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079153-004TOPIRAMATE200MGTABLET / ORAL2009-03-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079153-001TOPIRAMATE25MGTABLET / ORAL2009-03-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079153-002TOPIRAMATE50MGTABLET / ORAL2009-03-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079153-003TOPIRAMATE100MGTABLET / ORAL2009-03-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079153-004TOPIRAMATE200MGTABLET / ORAL2009-03-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079153-001TOPIRAMATE25MGTABLET / ORAL2009-03-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079153-002TOPIRAMATE50MGTABLET / ORAL2009-03-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079153-003TOPIRAMATE100MGTABLET / ORAL2009-03-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079153-004TOPIRAMATE200MGTABLET / ORAL2009-03-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A079153-001TOPIRAMATE25MGTABLET / ORAL2009-03-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A079153-002TOPIRAMATE50MGTABLET / ORAL2009-03-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A079153-003TOPIRAMATE100MGTABLET / ORAL2009-03-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A079153-004TOPIRAMATE200MGTABLET / ORAL2009-03-27d06236e962d9…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A079153-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A079153-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A079153-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A079153-004AB174a2ff9319b5…
2020-12-22 03:56 UTC2020-12A079153-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A079153-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A079153-003AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A079153-004AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A079153-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A079153-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A079153-003AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A079153-004AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A079153-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A079153-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A079153-003AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A079153-004AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A079153-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A079153-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A079153-003AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A079153-004AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A079153-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A079153-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A079153-003AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A079153-004AB1ea99ee380514…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e5b1b0ba-27f8-4d5d-8943-8aed080fdedcProduct name420260306
6c26dd6d-01b5-4a80-b096-b3a6f7ca6077Product name220250623
cb966f54-bbf0-40fb-b581-80c6648d510cProduct name420250623
6e2fb0d7-40d7-e97c-1375-fa022ff20193Product name420250305
3d272a3f-17c0-421d-bc43-3cbdb719258dProduct name120250303
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-033-01EA - Each13668-033651dde5d-6e53-4c77-8270-699106da630512012-07-24
13668-033-05EA - Each13668-033de867dd9-963d-401f-b806-1f271a14af6512012-07-24
13668-033-60EA - Each13668-033fed986bf-73c7-4385-8e5b-c832f1d117d312012-07-24
13668-033-64EA - Each13668-0335a669728-2f9e-4934-b467-e14fa47f2ca312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOPIRAMATEACTIVE INGREDIENT0H73WJJ391TOPIRAMATE TABLET [TORRENT PHARMACEUTICALS LIMITED]10
TOPIRAMATEACTIVE MOIETY0H73WJJ391TOPIRAMATE TABLET [TORRENT PHARMACEUTICALS LIMITED]10
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTOPIRAMATE TABLET [TORRENT PHARMACEUTICALS LIMITED]10
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TOPIRAMATE TABLET [TORRENT PHARMACEUTICALS LIMITED]10
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675TOPIRAMATE TABLET [TORRENT PHARMACEUTICALS LIMITED]10
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTOPIRAMATE TABLET [TORRENT PHARMACEUTICALS LIMITED]10
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTOPIRAMATE TABLET [TORRENT PHARMACEUTICALS LIMITED]10
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTOPIRAMATE TABLET [TORRENT PHARMACEUTICALS LIMITED]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TOPIRAMATE TABLET [TORRENT PHARMACEUTICALS LIMITED]10
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQTOPIRAMATE TABLET [TORRENT PHARMACEUTICALS LIMITED]10
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TOPIRAMATE TABLET [TORRENT PHARMACEUTICALS LIMITED]10
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJTOPIRAMATE TABLET [TORRENT PHARMACEUTICALS LIMITED]10
TALCINACTIVE INGREDIENT7SEV7J4R1UTOPIRAMATE TABLET [TORRENT PHARMACEUTICALS LIMITED]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTOPIRAMATE TABLET [TORRENT PHARMACEUTICALS LIMITED]10
TOPIRAMATEACTIVE INGREDIENT0H73WJJ391TOPIRAMATE TABLET [STAT RX USA LLC]3
TOPIRAMATEACTIVE MOIETY0H73WJJ391TOPIRAMATE TABLET [STAT RX USA LLC]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTOPIRAMATE TABLET [STAT RX USA LLC]3
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TOPIRAMATE TABLET [STAT RX USA LLC]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTOPIRAMATE TABLET [STAT RX USA LLC]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTOPIRAMATE TABLET [STAT RX USA LLC]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTOPIRAMATE TABLET [STAT RX USA LLC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TOPIRAMATE TABLET [STAT RX USA LLC]3
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQTOPIRAMATE TABLET [STAT RX USA LLC]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TOPIRAMATE TABLET [STAT RX USA LLC]3
TALCINACTIVE INGREDIENT7SEV7J4R1UTOPIRAMATE TABLET [STAT RX USA LLC]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTOPIRAMATE TABLET [STAT RX USA LLC]3
TOPIRAMATEACTIVE INGREDIENT0H73WJJ391TOPIRAMATE (TOPIRAMATE TABLET) TABLET [DIRECT RX]1
TOPIRAMATEACTIVE MOIETY0H73WJJ391TOPIRAMATE (TOPIRAMATE TABLET) TABLET [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTOPIRAMATE (TOPIRAMATE TABLET) TABLET [DIRECT RX]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TOPIRAMATE (TOPIRAMATE TABLET) TABLET [DIRECT RX]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTOPIRAMATE (TOPIRAMATE TABLET) TABLET [DIRECT RX]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTOPIRAMATE (TOPIRAMATE TABLET) TABLET [DIRECT RX]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTOPIRAMATE (TOPIRAMATE TABLET) TABLET [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TOPIRAMATE (TOPIRAMATE TABLET) TABLET [DIRECT RX]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQTOPIRAMATE (TOPIRAMATE TABLET) TABLET [DIRECT RX]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TOPIRAMATE (TOPIRAMATE TABLET) TABLET [DIRECT RX]1
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJTOPIRAMATE (TOPIRAMATE TABLET) TABLET [DIRECT RX]1
TALCINACTIVE INGREDIENT7SEV7J4R1UTOPIRAMATE (TOPIRAMATE TABLET) TABLET [DIRECT RX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTOPIRAMATE (TOPIRAMATE TABLET) TABLET [DIRECT RX]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199889topiramate 100 MG Oral TabletPSNefd1106b-d369-4651-b703-b0985ce93b793
199888topiramate 25 MG Oral TabletPSNefd1106b-d369-4651-b703-b0985ce93b793
151226topiramate 50 MG Oral TabletPSNefd1106b-d369-4651-b703-b0985ce93b793
199889topiramate 100 MG Oral TabletSCDefd1106b-d369-4651-b703-b0985ce93b793
199888topiramate 25 MG Oral TabletSCDefd1106b-d369-4651-b703-b0985ce93b793
151226topiramate 50 MG Oral TabletSCDefd1106b-d369-4651-b703-b0985ce93b793
199889topiramate 100 MG Oral TabletPSN0f686676-8d66-4f29-966c-0a31e2eee90c1
199889topiramate 100 MG Oral TabletSCD0f686676-8d66-4f29-966c-0a31e2eee90c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13668-033-31136680033312500 TABLET in 1 BOTTLE (13668-033-31) 2500 tablet2009-03-270000-00-00NoNoCurrent