topiramate

Product NDC
60760-577
11-digit product format
607600577
Labeler code
60760
Product ID
60760-577_4bd575ae-1a71-7ab9-e063-6394a90a7185
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
topiramate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
ST. MARY'S MEDICAL PARK PHARMACY
Application
ANDA078235
Marketing category
ANDA
Marketing start
2019-09-11
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
2027-12-31
Current FDA listing
Yes

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.

Historic NDC status page 1 of 1 · 5 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage60760-57760760-577-60DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage60760-57760760-577-60DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage60760-57760760-577-60DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage60760-57760760-577-60DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage60760-57760760-577-60DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…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
A078235-001TOPIRAMATETOPIRAMATE25MGTABLET / ORALAB2009-03-27
A078235-002TOPIRAMATETOPIRAMATE50MGTABLET / ORALAB2009-03-27
A078235-003TOPIRAMATETOPIRAMATE100MGTABLET / ORALAB2009-03-27
A078235-004TOPIRAMATETOPIRAMATE200MGTABLET / 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
A078235-001AB
A078235-002AB
A078235-003AB
A078235-004AB

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 · 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 UTC2026-02A078235-001TOPIRAMATE25MGTABLET / ORALAB2009-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078235-002TOPIRAMATE50MGTABLET / ORALAB2009-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078235-003TOPIRAMATE100MGTABLET / ORALAB2009-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078235-004TOPIRAMATE200MGTABLET / ORALAB2009-03-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078235-001TOPIRAMATE25MGTABLET / ORALAB2009-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078235-002TOPIRAMATE50MGTABLET / ORALAB2009-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078235-003TOPIRAMATE100MGTABLET / ORALAB2009-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078235-004TOPIRAMATE200MGTABLET / ORALAB2009-03-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A078235-001TOPIRAMATE25MGTABLET / ORALAB2009-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078235-002TOPIRAMATE50MGTABLET / ORALAB2009-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078235-003TOPIRAMATE100MGTABLET / ORALAB2009-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078235-004TOPIRAMATE200MGTABLET / ORALAB2009-03-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078235-001TOPIRAMATE25MGTABLET / ORALAB2009-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078235-002TOPIRAMATE50MGTABLET / ORALAB2009-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078235-003TOPIRAMATE100MGTABLET / ORALAB2009-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078235-004TOPIRAMATE200MGTABLET / ORALAB2009-03-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078235-001TOPIRAMATE25MGTABLET / ORALAB2009-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078235-002TOPIRAMATE50MGTABLET / ORALAB2009-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078235-003TOPIRAMATE100MGTABLET / ORALAB2009-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078235-004TOPIRAMATE200MGTABLET / ORALAB2009-03-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078235-001TOPIRAMATE25MGTABLET / ORALAB2009-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078235-002TOPIRAMATE50MGTABLET / ORALAB2009-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078235-003TOPIRAMATE100MGTABLET / ORALAB2009-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078235-004TOPIRAMATE200MGTABLET / ORALAB2009-03-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078235-001TOPIRAMATE25MGTABLET / ORALAB2009-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078235-002TOPIRAMATE50MGTABLET / ORALAB2009-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078235-003TOPIRAMATE100MGTABLET / ORALAB2009-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078235-004TOPIRAMATE200MGTABLET / ORALAB2009-03-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078235-001TOPIRAMATE25MGTABLET / ORALAB2009-03-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078235-002TOPIRAMATE50MGTABLET / ORALAB2009-03-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078235-003TOPIRAMATE100MGTABLET / ORALAB2009-03-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078235-004TOPIRAMATE200MGTABLET / ORALAB2009-03-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078235-001TOPIRAMATE25MGTABLET / ORALAB2009-03-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078235-002TOPIRAMATE50MGTABLET / ORALAB2009-03-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078235-003TOPIRAMATE100MGTABLET / ORALAB2009-03-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078235-004TOPIRAMATE200MGTABLET / ORALAB2009-03-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078235-001TOPIRAMATE25MGTABLET / ORALAB2009-03-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A078235-002TOPIRAMATE50MGTABLET / ORALAB2009-03-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A078235-003TOPIRAMATE100MGTABLET / ORALAB2009-03-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A078235-004TOPIRAMATE200MGTABLET / ORALAB2009-03-27d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A078235-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078235-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078235-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078235-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078235-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078235-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078235-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078235-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078235-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078235-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078235-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078235-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078235-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078235-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078235-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078235-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078235-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078235-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078235-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078235-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078235-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078235-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078235-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078235-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078235-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078235-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078235-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078235-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078235-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078235-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078235-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078235-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078235-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078235-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078235-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078235-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078235-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078235-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078235-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078235-004AB1d06236e962d9…

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.

Matched openFDA labels page 1 of 2 · 34 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
topiramateTOPIRAMATEREMEDYREPACK INC.7e0834ee-920b-496f-954d-f9d81c3ba2d62026-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078235
application number: ANDA078235
topiramateTOPIRAMATEREMEDYREPACK INC.0366164b-1846-443d-9564-dbe52d8d9b652026-07-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078235
application number: ANDA078235
topiramateTOPIRAMATESt. Mary's Medical Park Pharmacy92637f92-9d7c-c246-e053-2995a90a03472026-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078235
application number: ANDA078235
ndc (product): 60760-577
topiramateTOPIRAMATESt. Mary's Medical Park Pharmacy9221403c-467f-738e-e053-2995a90ac8fd2026-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078235
application number: ANDA078235
topiramateTOPIRAMATEBryant Ranch Prepack8abe45eb-cc75-4625-ae3d-5b2a038c49072026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078235
application number: ANDA078235
topiramateTOPIRAMATEBryant Ranch Prepackbffcd213-4f09-4a5b-8ccb-591a68be402b2026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078235
application number: ANDA078235
topiramateTOPIRAMATEBryant Ranch Prepack57462baf-2f32-4bde-9627-2214c8af93702026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078235
application number: ANDA078235
topiramateTOPIRAMATEBryant Ranch Prepackca9ce6c1-5a60-467a-9ad5-acc7a9f8ca152026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078235
application number: ANDA078235
topiramateTOPIRAMATECoupler LLC5461f33d-eaef-dce3-e063-6294a90aeff82026-06-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078235
application number: ANDA078235
topiramateTOPIRAMATEAvPAK53c3f980-f05b-c671-e063-6294a90a77d52026-06-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078235
application number: ANDA078235
topiramateTOPIRAMATEREMEDYREPACK INC.6f461f84-bfad-44fa-a2bd-5ea1566444b52026-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078235
application number: ANDA078235
topiramateTOPIRAMATEREMEDYREPACK INC.b7539f52-06e9-4663-b401-92f5f83653cc2026-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078235
application number: ANDA078235
topiramateTOPIRAMATEREMEDYREPACK INC.5ce65b7f-9215-47a8-a784-f87a810bd7e42026-05-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078235
application number: ANDA078235
topiramateTOPIRAMATEREMEDYREPACK INC.2f5b1b0b-fd8a-4c4e-a85a-519ca841a0db2026-05-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078235
application number: ANDA078235
topiramateTOPIRAMATEREMEDYREPACK INC.149d20de-f262-4567-aa97-d4d28a1653cb2026-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078235
application number: ANDA078235
topiramateTOPIRAMATEQuallent Pharmaceuticals Health LLC9dae6824-6913-42de-b98a-cdcb0d3b4a462026-04-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078235
application number: ANDA078235
topiramateTOPIRAMATEZydus Pharmaceuticals USA Inc.67dcdd6e-48bc-418e-a887-805929d83ce02026-04-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078235
application number: ANDA078235
topiramateTOPIRAMATENorthwind Health Company, LLCafd4c2b9-b80c-b43a-e053-2995a90ac9232026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078235
application number: ANDA078235
topiramateTOPIRAMATENorthwind Health Company, LLCf3321dc5-0fb7-0d12-e053-2a95a90a96942026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078235
application number: ANDA078235
topiramateTOPIRAMATENorthwind Health Company, LLCffd7be08-050e-dfcb-e053-6394a90ad2862026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078235
application number: ANDA078235

Additional Listing Data#

Finished product
Yes
Brand name base
topiramate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOPIRAMATE50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0H73WJJ391Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
151226Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
92637f92-9d7c-c246-e053-2995a90a0347Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60760-577-60topiramate60 in 1 BOTTLE, PLASTICTABLET, FILM COATED606
60760-577-90topiramate90 in 1 BOTTLE, PLASTICTABLET, FILM COATED906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-577-60EA - Each60760-5771b9978c3-f73e-4fbb-b2e7-861b0ae9e70a12019-10-07
60760-577-90EA - Each60760-57794c260db-af7a-47c6-ac12-1cb4b7a7058f12020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-577TOPIRAMATE TABLET, FILM COATED [ST. MARY'S MEDICAL PARK PHARMACY]5Current NDC, Legacy NDC, 2 package rows20250523_92637f92-9d7c-c246-e053-2995a90a0347.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
151226topiramate 50 MG Oral TabletPSN92637f92-9d7c-c246-e053-2995a90a03476
151226topiramate 50 MG Oral TabletSCD92637f92-9d7c-c246-e053-2995a90a03476

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60760-577-606076005776060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-577-60) 2025-05-130000-00-00NoNoCurrent
60760-577-906076005779090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-577-90) 2020-01-100000-00-00NoNoCurrent