TOPIRAMATE

Product NDC
61919-172
Requested package NDC
61919-172-90
11-digit product format
619190172
Labeler code
61919
Product ID
61919-172_9cad60e1-340f-1b7e-e053-2995a90a2a2b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TOPIRAMATE
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA079162
Marketing category
ANDA
Marketing start
2014-01-01
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
2021-12-31
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 packagepackage61919-17261919-172-90IInactivated by FDA2026-10-05

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 · 16 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08IInactivated by FDA1332a3947898…d4bfe170f9cd…
2019-12-08 06:16 UTC · source 2019-12-05EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A079162-001TOPIRAMATETOPIRAMATE25MGTABLET / ORALAB2009-03-27
A079162-002TOPIRAMATETOPIRAMATE50MGTABLET / ORALAB2009-03-27
A079162-003TOPIRAMATETOPIRAMATE100MGTABLET / ORALAB2009-03-27
A079162-004TOPIRAMATETOPIRAMATE200MGTABLET / ORALAB2009-03-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A079162-001AB
A079162-002AB
A079162-003AB
A079162-004AB

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 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A079162-001TOPIRAMATE25MGTABLET / ORALAB2009-03-2784e616aacf4f…
2026-09-14 22:38:342026-08A079162-002TOPIRAMATE50MGTABLET / ORALAB2009-03-2784e616aacf4f…
2026-09-14 22:38:342026-08A079162-003TOPIRAMATE100MGTABLET / ORALAB2009-03-2784e616aacf4f…
2026-09-14 22:38:342026-08A079162-004TOPIRAMATE200MGTABLET / ORALAB2009-03-2784e616aacf4f…
2026-08-18 06:07:402026-07A079162-001TOPIRAMATE25MGTABLET / ORALAB2009-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07A079162-002TOPIRAMATE50MGTABLET / ORALAB2009-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07A079162-003TOPIRAMATE100MGTABLET / ORALAB2009-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07A079162-004TOPIRAMATE200MGTABLET / ORALAB2009-03-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A079162-001TOPIRAMATE25MGTABLET / ORALAB2009-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079162-002TOPIRAMATE50MGTABLET / ORALAB2009-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079162-003TOPIRAMATE100MGTABLET / ORALAB2009-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079162-004TOPIRAMATE200MGTABLET / ORALAB2009-03-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079162-001TOPIRAMATE25MGTABLET / ORALAB2009-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079162-002TOPIRAMATE50MGTABLET / ORALAB2009-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079162-003TOPIRAMATE100MGTABLET / ORALAB2009-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079162-004TOPIRAMATE200MGTABLET / ORALAB2009-03-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A079162-001TOPIRAMATE25MGTABLET / ORALAB2009-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079162-002TOPIRAMATE50MGTABLET / ORALAB2009-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079162-003TOPIRAMATE100MGTABLET / ORALAB2009-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079162-004TOPIRAMATE200MGTABLET / ORALAB2009-03-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079162-001TOPIRAMATE25MGTABLET / ORALAB2009-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079162-002TOPIRAMATE50MGTABLET / ORALAB2009-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079162-003TOPIRAMATE100MGTABLET / ORALAB2009-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079162-004TOPIRAMATE200MGTABLET / ORALAB2009-03-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079162-001TOPIRAMATE25MGTABLET / ORALAB2009-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079162-002TOPIRAMATE50MGTABLET / ORALAB2009-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079162-003TOPIRAMATE100MGTABLET / ORALAB2009-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079162-004TOPIRAMATE200MGTABLET / ORALAB2009-03-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079162-001TOPIRAMATE25MGTABLET / ORALAB2009-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079162-002TOPIRAMATE50MGTABLET / ORALAB2009-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079162-003TOPIRAMATE100MGTABLET / ORALAB2009-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079162-004TOPIRAMATE200MGTABLET / ORALAB2009-03-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079162-001TOPIRAMATE25MGTABLET / ORALAB2009-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079162-002TOPIRAMATE50MGTABLET / ORALAB2009-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079162-003TOPIRAMATE100MGTABLET / ORALAB2009-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079162-004TOPIRAMATE200MGTABLET / ORALAB2009-03-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079162-001TOPIRAMATE25MGTABLET / ORALAB2009-03-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079162-002TOPIRAMATE50MGTABLET / ORALAB2009-03-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079162-003TOPIRAMATE100MGTABLET / ORALAB2009-03-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079162-004TOPIRAMATE200MGTABLET / ORALAB2009-03-275bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A079162-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A079162-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A079162-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A079162-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A079162-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A079162-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A079162-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A079162-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A079162-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079162-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079162-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079162-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079162-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079162-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079162-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079162-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A079162-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079162-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079162-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079162-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079162-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079162-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079162-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079162-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079162-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079162-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079162-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079162-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079162-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079162-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079162-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079162-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079162-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079162-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079162-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079162-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079162-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079162-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079162-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079162-004AB15bbf6a4d5a75…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-172-602023-01-30C16284748780-1f386c64a-14f7-0266-e053-dadaa90a7c1aTOPIRAMATE
61919-172-722023-01-30C16284748780-1f386c64a-14f7-0266-e053-dadaa90a7c1aTOPIRAMATE
61919-172-902023-01-30C16284748780-1f386c64a-14f7-0266-e053-dadaa90a7c1aTOPIRAMATE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-172-60TOPIRAMATE60 in 1 BOTTLETABLET606
61919-172-72TOPIRAMATE72 in 1 BOTTLETABLET726
61919-172-90TOPIRAMATE90 in 1 BOTTLETABLET906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-172-60EA - Each61919-17242aebbb2-1890-4a1b-8ade-5773a1cd41af12016-09-02
61919-172-72EA - Each61919-1729de3dc9c-7acc-4d3e-b3ae-8965f35931f812016-09-02
61919-172-90EA - Each61919-17231933657-42fa-4c57-b9e8-ab5fb4eb19f812016-09-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOPIRAMATEACTIVE INGREDIENT0H73WJJ391TOPIRAMATE TABLET [DIRECT RX]4
TOPIRAMATEACTIVE MOIETY0H73WJJ391TOPIRAMATE TABLET [DIRECT RX]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTOPIRAMATE TABLET [DIRECT RX]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTOPIRAMATE TABLET [DIRECT RX]4
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82TOPIRAMATE TABLET [DIRECT RX]4
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6TOPIRAMATE TABLET [DIRECT RX]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTOPIRAMATE TABLET [DIRECT RX]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TOPIRAMATE TABLET [DIRECT RX]4
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQTOPIRAMATE TABLET [DIRECT RX]4
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTOPIRAMATE TABLET [DIRECT RX]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TOPIRAMATE TABLET [DIRECT RX]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TOPIRAMATE TABLET [DIRECT RX]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTOPIRAMATE TABLET [DIRECT RX]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-172TOPIRAMATE TABLET [DIRECT RX]6Legacy NDC, 3 package rows20200122_4ce9b4dd-bcff-4157-a859-aa816e2b1226.zip

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.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TopiramateTOPIRAMATECipla USA Inc.4087eb3c-96e9-4d0a-b80b-663e1c86d2562025-04-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079162
application number: ANDA079162
TopiramateTOPIRAMATEEXELAN PHARMACEUTICALS INC.690baf58-1ec9-463e-99b7-d601362ea56b2025-04-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079162
application number: ANDA079162
TopiramateTOPIRAMATEAphena Pharma Solutions - Tennessee, LLC3b18b43c-0de2-4acf-b0d5-f1b601d496de2021-05-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079162
application number: ANDA079162
TopiramateTOPIRAMATEProficient Rx LPe9c4e279-0ef9-4e96-8741-dfe7556953d92021-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079162
application number: ANDA079162

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
151226topiramate 50 MG Oral TabletPSN4ce9b4dd-bcff-4157-a859-aa816e2b12266
151226topiramate 50 MG Oral TabletSCD4ce9b4dd-bcff-4157-a859-aa816e2b12266

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-172-906191901729090 TABLET in 1 BOTTLE (61919-172-90) 90 tablet2014-01-010000-00-00NoNoCurrent