topiramate

Product NDC
68788-8835
11-digit product format
687888835
Labeler code
68788
Product ID
68788-8835_bbf0f882-1dcc-415d-82bb-acc64f4dc2bc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
topiramate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA090162
Marketing category
ANDA
Marketing start
2025-02-21
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
2026-12-31
Current FDA listing
Yes

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
A090162-001TOPIRAMATETOPIRAMATE25MGTABLET / ORALAB2009-03-27
A090162-002TOPIRAMATETOPIRAMATE50MGTABLET / ORALAB2009-03-27
A090162-003TOPIRAMATETOPIRAMATE100MGTABLET / ORALAB2009-03-27
A090162-004TOPIRAMATETOPIRAMATE200MGTABLET / ORALAB2013-02-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090162-001AB
A090162-002AB
A090162-003AB
A090162-004AB

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 UTC2026-02A090162-001TOPIRAMATE25MGTABLET / ORALAB2009-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090162-002TOPIRAMATE50MGTABLET / ORALAB2009-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090162-003TOPIRAMATE100MGTABLET / ORALAB2009-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090162-004TOPIRAMATE200MGTABLET / ORALAB2013-02-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090162-001TOPIRAMATE25MGTABLET / ORALAB2009-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090162-002TOPIRAMATE50MGTABLET / ORALAB2009-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090162-003TOPIRAMATE100MGTABLET / ORALAB2009-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090162-004TOPIRAMATE200MGTABLET / ORALAB2013-02-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A090162-001TOPIRAMATE25MGTABLET / ORALAB2009-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090162-002TOPIRAMATE50MGTABLET / ORALAB2009-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090162-003TOPIRAMATE100MGTABLET / ORALAB2009-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090162-004TOPIRAMATE200MGTABLET / ORALAB2013-02-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090162-001TOPIRAMATE25MGTABLET / ORALAB2009-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090162-002TOPIRAMATE50MGTABLET / ORALAB2009-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090162-003TOPIRAMATE100MGTABLET / ORALAB2009-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090162-004TOPIRAMATE200MGTABLET / ORALAB2013-02-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090162-001TOPIRAMATE25MGTABLET / ORALAB2009-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090162-002TOPIRAMATE50MGTABLET / ORALAB2009-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090162-003TOPIRAMATE100MGTABLET / ORALAB2009-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090162-004TOPIRAMATE200MGTABLET / ORALAB2013-02-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090162-001TOPIRAMATE25MGTABLET / ORALAB2009-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090162-002TOPIRAMATE50MGTABLET / ORALAB2009-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090162-003TOPIRAMATE100MGTABLET / ORALAB2009-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090162-004TOPIRAMATE200MGTABLET / ORALAB2013-02-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090162-001TOPIRAMATE25MGTABLET / ORALAB2009-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090162-002TOPIRAMATE50MGTABLET / ORALAB2009-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090162-003TOPIRAMATE100MGTABLET / ORALAB2009-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090162-004TOPIRAMATE200MGTABLET / ORALAB2013-02-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090162-001TOPIRAMATE25MGTABLET / ORALAB2009-03-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090162-002TOPIRAMATE50MGTABLET / ORALAB2009-03-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090162-003TOPIRAMATE100MGTABLET / ORALAB2009-03-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090162-004TOPIRAMATE200MGTABLET / ORALAB2013-02-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090162-001TOPIRAMATE25MGTABLET / ORALAB2009-03-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090162-002TOPIRAMATE50MGTABLET / ORALAB2009-03-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090162-003TOPIRAMATE100MGTABLET / ORALAB2009-03-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090162-004TOPIRAMATE200MGTABLET / ORALAB2013-02-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090162-001TOPIRAMATE25MGTABLET / ORALAB2009-03-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A090162-002TOPIRAMATE50MGTABLET / ORALAB2009-03-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A090162-003TOPIRAMATE100MGTABLET / ORALAB2009-03-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A090162-004TOPIRAMATE200MGTABLET / ORALAB2013-02-19d06236e962d9…

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 UTC2026-02A090162-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090162-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090162-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090162-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090162-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090162-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090162-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090162-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090162-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090162-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090162-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090162-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090162-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090162-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090162-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090162-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090162-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090162-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090162-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090162-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090162-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090162-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090162-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090162-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090162-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090162-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090162-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090162-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090162-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090162-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090162-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090162-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090162-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090162-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090162-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090162-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090162-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090162-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090162-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090162-004AB1d06236e962d9…

Additional Listing Data#

Finished product
Yes
Brand name base
topiramate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOPIRAMATE100 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
199889Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
bbf0f882-1dcc-415d-82bb-acc64f4dc2bcAvailable 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
68788-8835-3topiramate30 in 1 BOTTLE, PLASTICTABLET, FILM COATED301
68788-8835-5topiramate15 in 1 BOTTLE, PLASTICTABLET, FILM COATED151
68788-8835-6topiramate60 in 1 BOTTLE, PLASTICTABLET, FILM COATED601
68788-8835-9topiramate90 in 1 BOTTLE, PLASTICTABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8835-3EA - Each68788-883517c54f95-7cbc-4500-955f-c38107f8b5e612025-05-14
68788-8835-5EA - Each68788-8835f4650424-4285-448a-89d3-dacb69561f6f12025-05-14
68788-8835-6EA - Each68788-8835f6eeea89-d22c-434c-8663-760eb3fd9bd512025-05-14
68788-8835-9EA - Each68788-883580a5f73a-b386-45a4-964f-568ce1184b4c12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8835TOPIRAMATE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 4 package rows20250224_bbf0f882-1dcc-415d-82bb-acc64f4dc2bc.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 2 · 30 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
topiramateTOPIRAMATESt. Mary's Medical Park Pharmacy46a305cb-ab73-0bca-e063-6294a90a9b852026-07-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090162
application number: ANDA090162
topiramateTOPIRAMATEBryant Ranch Prepack12cd9be8-c5c2-4a16-9164-87963e22a88e2026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090162
application number: ANDA090162
topiramateTOPIRAMATECoupler LLC52ba9c4f-e7d0-4352-e063-6394a90af7e22026-05-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090162
application number: ANDA090162
topiramateTOPIRAMATECoupler LLC50b10a3d-883c-8891-e063-6394a90a86a12026-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090162
application number: ANDA090162
topiramateTOPIRAMATEUnichem Pharmaceuticals (USA), Inc.6ee00e82-799d-445e-b658-a9712c49a28e2026-04-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090162
application number: ANDA090162
topiramateTOPIRAMATEREMEDYREPACK INC.be14624b-7eb9-4e7a-9274-1bb88270ecbe2026-03-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090162
application number: ANDA090162
topiramateTOPIRAMATEAdvanced Rx of Tennessee, LLC4b1d3130-cf3c-d7da-e063-6294a90a60792026-02-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090162
application number: ANDA090162
topiramateTOPIRAMATEPreferred Pharmaceuticals Inc.68b22d22-c2d3-4e90-b302-56f7cb7314272026-01-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090162
application number: ANDA090162
topiramateTOPIRAMATEA-S Medication Solutionsa5cffe7a-fdee-487a-bafb-a2d43e76c23c2025-11-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090162
application number: ANDA090162
topiramateTOPIRAMATEA-S Medication Solutionsc6918801-f22c-4ba4-a396-da484d4334ca2025-11-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090162
application number: ANDA090162
topiramateTOPIRAMATEBryant Ranch Prepack49701840-5a32-4ac1-8b07-5c61decacb952025-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090162
application number: ANDA090162
topiramateTOPIRAMATEBryant Ranch Prepackbf732c34-9078-496a-8093-f68594e76fcb2025-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090162
application number: ANDA090162
topiramateTOPIRAMATEBryant Ranch Prepack02cac021-e135-483f-bb5d-f3696eef06822025-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090162
application number: ANDA090162
topiramateTOPIRAMATEBryant Ranch Prepackc320999e-b940-44d8-bf31-2fb78835ac2d2025-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090162
application number: ANDA090162
topiramateTOPIRAMATEBryant Ranch Prepack073d075d-d019-4834-b55d-9b95879149752025-04-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090162
application number: ANDA090162
topiramateTOPIRAMATEAdvanced Rx of Tennessee, LLC30ca2fce-4e4c-439e-e063-6294a90af0762025-03-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090162
application number: ANDA090162
topiramateTOPIRAMATEPreferred Pharmaceuticals Inc.bbf0f882-1dcc-415d-82bb-acc64f4dc2bc2025-02-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090162
application number: ANDA090162
ndc (product): 68788-8835
topiramateTOPIRAMATEPreferred Pharmaceuticals Inc.288d6b40-8c87-4f16-85a7-86166b5ac77f2025-02-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090162
application number: ANDA090162
topiramateTOPIRAMATEAdvanced Rx of Tennessee, LLC2cf7ce9e-afc2-f94e-e063-6394a90a35d02025-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090162
application number: ANDA090162
topiramateTOPIRAMATEPreferred Pharmaceuticals Inc.521be3f1-3ee7-45c7-9f0c-17e08b6c8fca2025-01-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090162
application number: ANDA090162

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199889topiramate 100 MG Oral TabletPSNbbf0f882-1dcc-415d-82bb-acc64f4dc2bc1
199889topiramate 100 MG Oral TabletSCDbbf0f882-1dcc-415d-82bb-acc64f4dc2bc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8835-36878888350330 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-8835-3) 2025-02-21NoNoCurrent
68788-8835-56878888350515 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-8835-5) 2025-02-21NoNoCurrent
68788-8835-66878888350660 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-8835-6) 2025-02-21NoNoCurrent
68788-8835-96878888350990 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-8835-9) 2025-02-21NoNoCurrent