TOPIRAMATE

Product NDC
63187-059
11-digit product format
631870059
Labeler code
63187
Product ID
63187-059_f68b2272-7a9d-4838-89ff-a10064e49015
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TOPIRAMATE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA090278
Marketing category
ANDA
Marketing start
2009-03-27
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
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
A090278-001TOPIRAMATETOPIRAMATE25MGTABLET / ORALAB2009-03-27
A090278-002TOPIRAMATETOPIRAMATE50MGTABLET / ORALAB2009-03-27
A090278-003TOPIRAMATETOPIRAMATE100MGTABLET / ORALAB2009-03-27
A090278-004TOPIRAMATETOPIRAMATE200MGTABLET / ORAL2009-03-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A090278-001AB
A090278-002AB
A090278-003AB

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 3 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090278-001TOPIRAMATE25MGTABLET / ORALAB2009-03-2787673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090278-002TOPIRAMATE50MGTABLET / ORALAB2009-03-2787673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090278-003TOPIRAMATE100MGTABLET / ORALAB2009-03-2787673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090278-004TOPIRAMATE200MGTABLET / ORALAB2009-03-2787673890dc5c…
2021-03-12 10:30 UTC2021-03A090278-001TOPIRAMATE25MGTABLET / ORALAB2009-03-275aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A090278-002TOPIRAMATE50MGTABLET / ORALAB2009-03-275aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A090278-003TOPIRAMATE100MGTABLET / ORALAB2009-03-275aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A090278-004TOPIRAMATE200MGTABLET / ORALAB2009-03-275aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090278-001TOPIRAMATE25MGTABLET / ORALAB2009-03-278869cabd3fbd…
2020-12-22 03:56 UTC2020-12A090278-002TOPIRAMATE50MGTABLET / ORALAB2009-03-278869cabd3fbd…
2020-12-22 03:56 UTC2020-12A090278-003TOPIRAMATE100MGTABLET / ORALAB2009-03-278869cabd3fbd…
2020-12-22 03:56 UTC2020-12A090278-004TOPIRAMATE200MGTABLET / ORALAB2009-03-278869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090278-001TOPIRAMATE25MGTABLET / ORALAB2009-03-27c0c555d07b60…
2020-11-12 02:37 UTC2020-11A090278-002TOPIRAMATE50MGTABLET / ORALAB2009-03-27c0c555d07b60…
2020-11-12 02:37 UTC2020-11A090278-003TOPIRAMATE100MGTABLET / ORALAB2009-03-27c0c555d07b60…
2020-11-12 02:37 UTC2020-11A090278-004TOPIRAMATE200MGTABLET / ORALAB2009-03-27c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090278-001TOPIRAMATE25MGTABLET / ORALAB2009-03-273f01610625f2…
2019-12-14 00:12 UTC2019-12A090278-002TOPIRAMATE50MGTABLET / ORALAB2009-03-273f01610625f2…
2019-12-14 00:12 UTC2019-12A090278-003TOPIRAMATE100MGTABLET / ORALAB2009-03-273f01610625f2…
2019-12-14 00:12 UTC2019-12A090278-004TOPIRAMATE200MGTABLET / ORALAB2009-03-273f01610625f2…
2019-09-15 20:21 UTC2019-09A090278-001TOPIRAMATE25MGTABLET / ORALAB2009-03-27b00525d2431f…
2019-09-15 20:21 UTC2019-09A090278-002TOPIRAMATE50MGTABLET / ORALAB2009-03-27b00525d2431f…
2019-09-15 20:21 UTC2019-09A090278-003TOPIRAMATE100MGTABLET / ORALAB2009-03-27b00525d2431f…
2019-09-15 20:21 UTC2019-09A090278-004TOPIRAMATE200MGTABLET / ORALAB2009-03-27b00525d2431f…
2019-07-19 19:46 UTC2019-07A090278-001TOPIRAMATE25MGTABLET / ORALAB2009-03-27ea99ee380514…
2019-07-19 19:46 UTC2019-07A090278-002TOPIRAMATE50MGTABLET / ORALAB2009-03-27ea99ee380514…
2019-07-19 19:46 UTC2019-07A090278-003TOPIRAMATE100MGTABLET / ORALAB2009-03-27ea99ee380514…
2019-07-19 19:46 UTC2019-07A090278-004TOPIRAMATE200MGTABLET / ORALAB2009-03-27ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090278-001TOPIRAMATE25MGTABLET / ORALAB2009-03-276a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090278-002TOPIRAMATE50MGTABLET / ORALAB2009-03-276a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090278-003TOPIRAMATE100MGTABLET / ORALAB2009-03-276a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090278-004TOPIRAMATE200MGTABLET / ORALAB2009-03-276a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090278-001TOPIRAMATE25MGTABLET / ORALAB2009-03-271c564ffb4f44…
2024-02-18 07:12 UTC2024-02A090278-002TOPIRAMATE50MGTABLET / ORALAB2009-03-271c564ffb4f44…
2024-02-18 07:12 UTC2024-02A090278-003TOPIRAMATE100MGTABLET / ORALAB2009-03-271c564ffb4f44…
2024-02-18 07:12 UTC2024-02A090278-004TOPIRAMATE200MGTABLET / ORALAB2009-03-271c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090278-001TOPIRAMATE25MGTABLET / ORALAB2009-03-27ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A090278-002TOPIRAMATE50MGTABLET / ORALAB2009-03-27ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A090278-003TOPIRAMATE100MGTABLET / ORALAB2009-03-27ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A090278-004TOPIRAMATE200MGTABLET / ORALAB2009-03-27ea1830bbd6c7…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 160 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A090278-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090278-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090278-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090278-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090278-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090278-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090278-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090278-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090278-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090278-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090278-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090278-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090278-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090278-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090278-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090278-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090278-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090278-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090278-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090278-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090278-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090278-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090278-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090278-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090278-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090278-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090278-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090278-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090278-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090278-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090278-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090278-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090278-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090278-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090278-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090278-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090278-004AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090278-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090278-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090278-003AB179d66fd596c7…

Additional Listing Data#

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

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 · 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
a30c583a-4b0a-43a6-ae76-19b1a5e916caAvailable 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
63187-059-30TOPIRAMATE30 in 1 BOTTLETABLET, FILM COATED305
63187-059-90TOPIRAMATE90 in 1 BOTTLETABLET, FILM COATED905

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOPIRAMATEACTIVE INGREDIENT0H73WJJ391TOPIRAMATE TABLET, FILM COATED [PROFICIENT RX LP]2
TOPIRAMATEACTIVE MOIETY0H73WJJ391TOPIRAMATE TABLET, FILM COATED [PROFICIENT RX LP]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTOPIRAMATE TABLET, FILM COATED [PROFICIENT RX LP]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTOPIRAMATE TABLET, FILM COATED [PROFICIENT RX LP]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTOPIRAMATE TABLET, FILM COATED [PROFICIENT RX LP]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTOPIRAMATE TABLET, FILM COATED [PROFICIENT RX LP]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TOPIRAMATE TABLET, FILM COATED [PROFICIENT RX LP]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATOPIRAMATE TABLET, FILM COATED [PROFICIENT RX LP]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990TOPIRAMATE TABLET, FILM COATED [PROFICIENT RX LP]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TOPIRAMATE TABLET, FILM COATED [PROFICIENT RX LP]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTOPIRAMATE TABLET, FILM COATED [PROFICIENT RX LP]2
TALCINACTIVE INGREDIENT7SEV7J4R1UTOPIRAMATE TABLET, FILM COATED [PROFICIENT RX LP]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTOPIRAMATE TABLET, FILM COATED [PROFICIENT RX LP]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-059TOPIRAMATE TABLET, FILM COATED [PROFICIENT RX LP]5Current NDC, Legacy NDC, 2 package rows20221012_a30c583a-4b0a-43a6-ae76-19b1a5e916ca.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 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TopiramateTOPIRAMATEPD-Rx Pharmaceuticals, Inc.e846124d-e9e6-42c7-83f1-5df170d3f70b2026-07-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090278
application number: ANDA090278
TopiramateTOPIRAMATEBryant Ranch Prepack47ef2964-3a41-4bfd-86fb-d44560b9961f2026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090278
application number: ANDA090278
TopiramateTOPIRAMATEBryant Ranch Prepack484c132f-3d3d-4218-b22f-82e9b56cc2f42026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090278
application number: ANDA090278
TopiramateTOPIRAMATEPD-Rx Pharmaceuticals, Inc.1b847969-2124-4350-94b0-ef5ba707673b2026-06-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090278
application number: ANDA090278
TopiramateTOPIRAMATEPD-Rx Pharmaceuticals, Inc.021005ab-6a00-40d8-9aee-20c91613b4d52026-06-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090278
application number: ANDA090278
TopiramateTOPIRAMATESun Pharmaceutical Industries, Inc.3c909a53-ae66-4b28-a741-b60bb25a69cf2026-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090278
application number: ANDA090278
TopiramateTOPIRAMATEBryant Ranch Prepack61390be3-7553-4cb5-b5da-7571ed7d4b172024-08-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090278
application number: ANDA090278
TopiramateTOPIRAMATEBryant Ranch Prepackffaacad8-4594-45a8-b292-02a84cd0c35b2024-08-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090278
application number: ANDA090278
TopiramateTOPIRAMATENuCare Pharmaceuticals,Inc.9ddb8451-a455-87ec-e053-2995a90a5e5e2024-06-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090278
application number: ANDA090278
TopiramateTOPIRAMATEProficient Rx LP8bd03bb2-3b9b-4707-a9a4-5618ddc3832f2023-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090278
application number: ANDA090278
TOPIRAMATETOPIRAMATEProficient Rx LPa30c583a-4b0a-43a6-ae76-19b1a5e916ca2022-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090278
application number: ANDA090278
ndc (product): 63187-059
TopiramateTOPIRAMATEProficient Rx LPe382a731-ef73-4990-bc74-ffc3a91ff3ba2022-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090278
application number: ANDA090278
TopiramateTOPIRAMATEProficient Rx LP7d6752ce-7a56-4b04-ab15-cbd40aa5cc942019-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090278
application number: ANDA090278
TopiramateTOPIRAMATESun Pharmaceutical Industries, Inc.2d9513e0-2fb8-46c9-bbd6-b03efd31c3ef2018-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090278
application number: ANDA090278

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199889topiramate 100 MG Oral TabletPSNa30c583a-4b0a-43a6-ae76-19b1a5e916ca5
199888topiramate 25 MG Oral TabletPSNa30c583a-4b0a-43a6-ae76-19b1a5e916ca5
151226topiramate 50 MG Oral TabletPSNa30c583a-4b0a-43a6-ae76-19b1a5e916ca5
199889topiramate 100 MG Oral TabletSCDa30c583a-4b0a-43a6-ae76-19b1a5e916ca5
199888topiramate 25 MG Oral TabletSCDa30c583a-4b0a-43a6-ae76-19b1a5e916ca5
151226topiramate 50 MG Oral TabletSCDa30c583a-4b0a-43a6-ae76-19b1a5e916ca5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-059-306318700593030 TABLET, FILM COATED in 1 BOTTLE (63187-059-30) 2019-01-010000-00-00NoNoCurrent
63187-059-906318700599090 TABLET, FILM COATED in 1 BOTTLE (63187-059-90) 2019-01-010000-00-00NoNoCurrent