FDA.reportPublic FDA data

topiramate

Product NDC
50090-5309
11-digit product format
500905309
Labeler code
50090
Product ID
50090-5309_3a4d1f5a-8e48-45a1-944a-5e49c6db501c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
topiramate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078235
Marketing category
ANDA
Marketing start
2009-03-27
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
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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A078235-001TOPIRAMATE25MGTABLET / ORALAB2009-03-27a50c72e98297…
2026-08-01 22:54:322026-06A078235-002TOPIRAMATE50MGTABLET / ORALAB2009-03-27a50c72e98297…
2026-08-01 22:54:322026-06A078235-003TOPIRAMATE100MGTABLET / ORALAB2009-03-27a50c72e98297…
2026-08-01 22:54:322026-06A078235-004TOPIRAMATE200MGTABLET / ORALAB2009-03-27a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A078235-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A078235-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A078235-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A078235-004AB1a50c72e98297…

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 · 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
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

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
674c2c2e-014a-43a1-91a7-7214ffc4b1d7Available 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
50090-5309-0topiramate60 in 1 BOTTLETABLET, FILM COATED6010
50090-5309-1topiramate30 in 1 BOTTLETABLET, FILM COATED3010
50090-5309-2topiramate90 in 1 BOTTLETABLET, FILM COATED9010
50090-5309-3topiramate180 in 1 BOTTLETABLET, FILM COATED18010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5309-0EA - Each50090-53093913e61d-12af-4aee-b1c6-a6480d7efa2512023-01-09
50090-5309-1EA - Each50090-530931342113-e492-432b-9cfb-197ae7e0bd3412023-01-09
50090-5309-2EA - Each50090-53091014de82-c8aa-4fd7-a9d2-b2ac75497cb012023-01-09
50090-5309-3EA - Each50090-53097c3070b0-bf19-4e9c-93e9-cce107ba13c612023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5309TOPIRAMATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]8Current NDC, Legacy NDC, 4 package rows20230912_674c2c2e-014a-43a1-91a7-7214ffc4b1d7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199889topiramate 100 MG Oral TabletPSN674c2c2e-014a-43a1-91a7-7214ffc4b1d710
199889topiramate 100 MG Oral TabletSCD674c2c2e-014a-43a1-91a7-7214ffc4b1d710

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5309-05009053090060 TABLET, FILM COATED in 1 BOTTLE (50090-5309-0) 2020-10-280000-00-00NoNoCurrent
50090-5309-15009053090130 TABLET, FILM COATED in 1 BOTTLE (50090-5309-1) 2020-10-280000-00-00NoNoCurrent
50090-5309-25009053090290 TABLET, FILM COATED in 1 BOTTLE (50090-5309-2) 2020-10-280000-00-00NoNoCurrent
50090-5309-350090530903180 TABLET, FILM COATED in 1 BOTTLE (50090-5309-3) 2022-03-100000-00-00NoNoCurrent