topiramate

Product NDC
70518-1180
Requested package NDC
70518-1180-0
11-digit product format
705181180
Labeler code
70518
Product ID
70518-1180_5230d81d-b6b2-4cc4-e063-6294a90a31e6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
topiramate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA078235
Marketing category
ANDA
Marketing start
2018-05-14
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70518-118070518-1180-0DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70518-118070518-1180-0DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70518-118070518-1180-0DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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…

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
2f5b1b0b-fd8a-4c4e-a85a-519ca841a0dbAvailable 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
70518-1180-0topiramate30 in 1 BLISTER PACKTABLET, FILM COATED3019
70518-1180-1topiramate100 in 1 BOXTABLET, FILM COATED10019
70518-1180-2topiramate1 in 1 POUCHTABLET, FILM COATED119
70518-1180-3topiramate30 in 1 BOXTABLET, FILM COATED3019

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1180TOPIRAMATE TABLET, FILM COATED [REMEDYREPACK INC.]13Current NDC, Legacy NDC, 4 package rows20250508_2f5b1b0b-fd8a-4c4e-a85a-519ca841a0db.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 · 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
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
ndc (package): 70518-1180-0
ndc (product): 70518-1180
ndc11 (package): 70518118000
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
151226topiramate 50 MG Oral TabletPSN2f5b1b0b-fd8a-4c4e-a85a-519ca841a0db19
151226topiramate 50 MG Oral TabletSCD2f5b1b0b-fd8a-4c4e-a85a-519ca841a0db19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-1180-07051811800030 TABLET, FILM COATED in 1 BLISTER PACK (70518-1180-0) 2018-05-140000-00-00NoNoCurrent