topiramate

Product NDC
50090-2102
11-digit product format
500902102
Labeler code
50090
Product ID
50090-2102_5c0321da-e5aa-4817-bf12-3212f9becaa0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
topiramate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090162
Marketing category
ANDA
Marketing start
2013-07-01
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
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…

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 · 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
ndc (product): 50090-2102
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
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOPIRAMATE25 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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
151226Internal RxNorm lookup
199888Internal RxNorm lookup
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
a5cffe7a-fdee-487a-bafb-a2d43e76c23cAvailable 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
50090-2102-0topiramate60 in 1 BOTTLETABLET, FILM COATED6025
50090-2102-1topiramate90 in 1 BOTTLETABLET, FILM COATED9025
50090-2102-2topiramate30 in 1 BOTTLETABLET, FILM COATED3025

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2102-0EA - Each50090-2102816f0417-c5a9-47bd-a944-d3859c2e617912019-02-13
50090-2102-1EA - Each50090-2102aacddd0c-d707-43b7-8d4f-06f937b0a24c12018-12-13
50090-2102-2EA - Each50090-2102ec9e3ce4-a78d-4724-8b28-4e296782591b12019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2102TOPIRAMATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]22Current NDC, Legacy NDC, 3 package rows20241010_a5cffe7a-fdee-487a-bafb-a2d43e76c23c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199889topiramate 100 MG Oral TabletPSNa5cffe7a-fdee-487a-bafb-a2d43e76c23c25
199888topiramate 25 MG Oral TabletPSNa5cffe7a-fdee-487a-bafb-a2d43e76c23c25
151226topiramate 50 MG Oral TabletPSNa5cffe7a-fdee-487a-bafb-a2d43e76c23c25
199889topiramate 100 MG Oral TabletSCDa5cffe7a-fdee-487a-bafb-a2d43e76c23c25
199888topiramate 25 MG Oral TabletSCDa5cffe7a-fdee-487a-bafb-a2d43e76c23c25
151226topiramate 50 MG Oral TabletSCDa5cffe7a-fdee-487a-bafb-a2d43e76c23c25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-2102-05009021020060 TABLET, FILM COATED in 1 BOTTLE (50090-2102-0) 2015-10-130000-00-00NoNoCurrent
50090-2102-15009021020190 TABLET, FILM COATED in 1 BOTTLE (50090-2102-1) 2015-10-130000-00-00NoNoCurrent
50090-2102-25009021020230 TABLET, FILM COATED in 1 BOTTLE (50090-2102-2) 2015-10-130000-00-00NoNoCurrent