Topiramate

Product NDC
43063-729
11-digit product format
430630729
Labeler code
43063
Product ID
43063-729_39f936c5-d108-6804-e063-6394a90add94
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Topiramate
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA076343
Marketing category
ANDA
Marketing start
2014-06-12
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 42.

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
A076343-001TOPIRAMATETOPIRAMATE25MGTABLET / ORALAB2009-03-27
A076343-002TOPIRAMATETOPIRAMATE50MGTABLET / ORALAB2009-03-27
A076343-003TOPIRAMATETOPIRAMATE100MGTABLET / ORALAB2009-03-27
A076343-004TOPIRAMATETOPIRAMATE200MGTABLET / 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
A076343-001AB
A076343-002AB
A076343-003AB
A076343-004AB

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 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A076343-001TOPIRAMATE25MGTABLET / ORALAB2009-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07A076343-002TOPIRAMATE50MGTABLET / ORALAB2009-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07A076343-003TOPIRAMATE100MGTABLET / ORALAB2009-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07A076343-004TOPIRAMATE200MGTABLET / ORALAB2009-03-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076343-001TOPIRAMATE25MGTABLET / ORALAB2009-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076343-002TOPIRAMATE50MGTABLET / ORALAB2009-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076343-003TOPIRAMATE100MGTABLET / ORALAB2009-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076343-004TOPIRAMATE200MGTABLET / ORALAB2009-03-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076343-001TOPIRAMATE25MGTABLET / ORALAB2009-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076343-002TOPIRAMATE50MGTABLET / ORALAB2009-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076343-003TOPIRAMATE100MGTABLET / ORALAB2009-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076343-004TOPIRAMATE200MGTABLET / ORALAB2009-03-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A076343-001TOPIRAMATE25MGTABLET / ORALAB2009-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076343-002TOPIRAMATE50MGTABLET / ORALAB2009-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076343-003TOPIRAMATE100MGTABLET / ORALAB2009-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076343-004TOPIRAMATE200MGTABLET / ORALAB2009-03-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076343-001TOPIRAMATE25MGTABLET / ORALAB2009-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076343-002TOPIRAMATE50MGTABLET / ORALAB2009-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076343-003TOPIRAMATE100MGTABLET / ORALAB2009-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076343-004TOPIRAMATE200MGTABLET / ORALAB2009-03-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076343-001TOPIRAMATE25MGTABLET / ORALAB2009-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076343-002TOPIRAMATE50MGTABLET / ORALAB2009-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076343-003TOPIRAMATE100MGTABLET / ORALAB2009-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076343-004TOPIRAMATE200MGTABLET / ORALAB2009-03-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076343-001TOPIRAMATE25MGTABLET / ORALAB2009-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076343-002TOPIRAMATE50MGTABLET / ORALAB2009-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076343-003TOPIRAMATE100MGTABLET / ORALAB2009-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076343-004TOPIRAMATE200MGTABLET / ORALAB2009-03-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076343-001TOPIRAMATE25MGTABLET / ORALAB2009-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076343-002TOPIRAMATE50MGTABLET / ORALAB2009-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076343-003TOPIRAMATE100MGTABLET / ORALAB2009-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076343-004TOPIRAMATE200MGTABLET / ORALAB2009-03-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076343-001TOPIRAMATE25MGTABLET / ORALAB2009-03-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076343-002TOPIRAMATE50MGTABLET / ORALAB2009-03-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076343-003TOPIRAMATE100MGTABLET / ORALAB2009-03-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076343-004TOPIRAMATE200MGTABLET / ORALAB2009-03-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076343-001TOPIRAMATE25MGTABLET / ORALAB2009-03-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076343-002TOPIRAMATE50MGTABLET / ORALAB2009-03-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076343-003TOPIRAMATE100MGTABLET / ORALAB2009-03-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076343-004TOPIRAMATE200MGTABLET / ORALAB2009-03-27d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A076343-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076343-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076343-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076343-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076343-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076343-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076343-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076343-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076343-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076343-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076343-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076343-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076343-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076343-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076343-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076343-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076343-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076343-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076343-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076343-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076343-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076343-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076343-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076343-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076343-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076343-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076343-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076343-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076343-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076343-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076343-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076343-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076343-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076343-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076343-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076343-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076343-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076343-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076343-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076343-004AB1d8e5a09893c0…

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
9e516204-8f39-43c9-9f7e-d9777586f321Available 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
43063-729-07Topiramate7 in 1 BOTTLE, PLASTICTABLET722
43063-729-21Topiramate21 in 1 BOTTLE, PLASTICTABLET2122
43063-729-28Topiramate28 in 1 BOTTLE, PLASTICTABLET2822
43063-729-30Topiramate30 in 1 BOTTLE, PLASTICTABLET3022
43063-729-60Topiramate60 in 1 BOTTLE, PLASTICTABLET6022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-729-07EA - Each43063-72905866845-4947-4b89-929e-4cfa467ea27112018-04-19
43063-729-21EA - Each43063-7299cdd4f54-f228-4ce1-b495-f487d7bdee4012017-03-06
43063-729-28EA - Each43063-729dda3a49a-5790-49db-bbca-d9ea42a80fc112017-03-06
43063-729-30EA - Each43063-729ae2af2c1-7823-43f8-98f0-5c5fc752bebf12018-02-20
43063-729-60EA - Each43063-72962a628ab-748d-4f82-b4c5-c445db696dc012017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-729TOPIRAMATE TABLET [PD-RX PHARMACEUTICALS, INC.]21Current NDC, Legacy NDC, 5 package rows20250123_9e516204-8f39-43c9-9f7e-d9777586f321.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 · 29 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TopiramateTOPIRAMATEREMEDYREPACK INC.c90d81a9-a87b-48b0-8cf1-172b82e301272026-07-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076343
application number: ANDA076343
TopiramateTOPIRAMATEREMEDYREPACK INC.44095c2b-2e90-45d2-ab45-d0961c41550d2026-07-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076343
application number: ANDA076343
TopiramateTOPIRAMATEREMEDYREPACK INC.b71c09c5-43dd-4d98-9ab6-0b0c99908cac2026-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076343
application number: ANDA076343
TopiramateTOPIRAMATEREMEDYREPACK INC.f8aaf403-0e15-4bbb-b88b-253d934396882026-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076343
application number: ANDA076343
TopiramateTOPIRAMATECoupler LLC55f2aca4-b961-a746-e063-6294a90ae8ce2026-07-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076343
application number: ANDA076343
TopiramateTOPIRAMATEREMEDYREPACK INC.0cf388dc-d8f1-4478-bf5f-e64638ee58012026-06-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076343
application number: ANDA076343
TopiramateTOPIRAMATEC164cb1f7-1a41-675f-e063-6294a90ae0dd2026-03-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076343
application number: ANDA076343
TopiramateTOPIRAMATEA-S Medication Solutions7f1e4475-6326-47a3-a317-b04b74b7c1092026-02-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076343
application number: ANDA076343
TopiramateTOPIRAMATEA-S Medication Solutions55e71f43-1cd5-4efc-9641-fda0a09c30f02026-02-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076343
application number: ANDA076343
TopiramateTOPIRAMATENorthwind Health Company, LLCca45d478-7214-5bc7-e053-2995a90aa6012026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076343
application number: ANDA076343
TopiramateTOPIRAMATEPD-Rx Pharmaceuticals, Inc.1f327383-beb3-4d15-add6-5f1c749f2b3f2025-11-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076343
application number: ANDA076343
TopiramateTOPIRAMATENuCare Pharmaceuticals, Inc.490f109f-30cb-0790-e054-00144ff88e882025-07-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076343
application number: ANDA076343
TopiramateTOPIRAMATEPD-Rx Pharmaceuticals, Inc.9e516204-8f39-43c9-9f7e-d9777586f3212025-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076343
application number: ANDA076343
ndc (product): 43063-729
TopiramateTOPIRAMATEPD-Rx Pharmaceuticals, Inc.e39d2549-b489-426d-b576-741537e112e72025-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076343
application number: ANDA076343
TopiramateTOPIRAMATEA-S Medication Solutionsf16b14a2-297f-4adb-8d7a-5f43785faef72025-06-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076343
application number: ANDA076343
TopiramateTOPIRAMATEA-S Medication Solutionsea0bcab1-cfe1-491c-875e-8c865449557e2025-04-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076343
application number: ANDA076343
TopiramateTOPIRAMATECipla USA Inc.ca4ec248-285d-4066-8f89-5ed0c538c4c92025-04-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076343
application number: ANDA076343
TopiramateTOPIRAMATEProficient Rx LPd63b64dd-b420-4283-9bac-92ba43c9f4292025-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076343
application number: ANDA076343
TopiramateTOPIRAMATEAdvanced Rx Pharmacy of Tennessee, LLCeca774cf-2e4e-7642-e053-2a95a90a847d2024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076343
application number: ANDA076343
TopiramateTOPIRAMATEAdvanced Rx Pharmacy of Tennessee, LLCd8dff98f-185e-77ba-e053-2995a90aed2f2024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076343
application number: ANDA076343

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199889topiramate 100 MG Oral TabletPSN9e516204-8f39-43c9-9f7e-d9777586f32122
199889topiramate 100 MG Oral TabletSCD9e516204-8f39-43c9-9f7e-d9777586f32122

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-729-07430630729077 TABLET in 1 BOTTLE, PLASTIC (43063-729-07) 7 tablet2018-03-070000-00-00NoNoCurrent
43063-729-214306307292121 TABLET in 1 BOTTLE, PLASTIC (43063-729-21) 21 tablet2017-01-310000-00-00NoNoCurrent
43063-729-284306307292828 TABLET in 1 BOTTLE, PLASTIC (43063-729-28) 28 tablet2016-12-280000-00-00NoNoCurrent
43063-729-304306307293030 TABLET in 1 BOTTLE, PLASTIC (43063-729-30) 30 tablet2017-12-310000-00-00NoNoCurrent
43063-729-604306307296060 TABLET in 1 BOTTLE, PLASTIC (43063-729-60) 60 tablet2016-11-290000-00-00NoNoCurrent