FDA.reportPublic FDA data

NDC 80425-0208-01 - Topiramate

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
80425-0208
Requested NDC
80425-0208-01
Package NDCs from labels
80425-0208-1, 80425-0208-2, 80425-0208-3, 80425-0208-01
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2024-12-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Topiramate - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0208-1Topiramate60 in 1 BOTTLETABLET603
80425-0208-2Topiramate30 in 1 BOTTLETABLET303
80425-0208-3Topiramate90 in 1 BOTTLETABLET903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0208TOPIRAMATE TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]3Current NDC, Legacy NDC, 3 package rows20250101_eca774cf-2e4e-7642-e053-2a95a90a847d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0208-1EA - Each80425-020851098446-252b-47dd-815c-48f7a3c9f1c412023-04-07
80425-0208-2EA - Each80425-0208f3740312-abf9-4506-b6bf-54643e59401112023-06-06
80425-0208-3EA - Each80425-0208f818edb6-3f4d-46b9-8ae8-2ab2543caeca12023-06-06

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 3 of 8 · 147 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TopiramateTOPIRAMATEUpsher-Smith Laboratories, LLC691d276c-9cc1-4d39-828f-0f44d7ef63282026-05-15Warnings, Adverse reactionsExact identifier
unii: 0H73WJJ391
TopiramateTOPIRAMATEVitruvias Therapeutics, Inc.a9d7c5ef-daf9-4f97-8673-7f4a2007f4082026-05-07Warnings, Adverse reactionsExact identifier
unii: 0H73WJJ391
TOPIRAMATETOPIRAMATEGlenmark Pharmaceuticals Inc., USA54bfabce-1f8a-40ee-8b55-efce8fe6fbf12026-04-30Warnings, Adverse reactionsExact identifier
unii: 0H73WJJ391
topiramateTOPIRAMATECoupler LLC50b10a3d-883c-8891-e063-6394a90a86a12026-04-30Warnings, Adverse reactionsExact identifier
rxcui: 151226
unii: 0H73WJJ391
TopiramateTOPIRAMATEGlenmark Pharmaceuticals Inc., USA872927eb-0b61-44bb-9892-3c700b6f21812026-04-29Warnings, Adverse reactionsExact identifier
unii: 0H73WJJ391
topiramateTOPIRAMATEQuallent Pharmaceuticals Health LLC9dae6824-6913-42de-b98a-cdcb0d3b4a462026-04-25Warnings, Adverse reactionsExact identifier
rxcui: 151226
rxcui: 199889
rxcui: 199888
unii: 0H73WJJ391
QsymiaPHENTERMINE AND TOPIRAMATEVivus LLC40dd5602-53da-45ac-bb4b-15789aba40f92026-04-22Warnings, Adverse reactionsExact identifier
unii: 0H73WJJ391
topiramateTOPIRAMATEZydus Pharmaceuticals USA Inc.e4886adf-199d-4b19-a4ef-75f8f94cb54e2026-04-22Warnings, Adverse reactionsExact identifier
unii: 0H73WJJ391
TopiramateTOPIRAMATEAjanta Pharma USA Inc.b94629e3-ae2e-473e-b2f5-06e32ee19aa92026-04-20Warnings, Adverse reactionsExact identifier
unii: 0H73WJJ391
TopiramateTOPIRAMATEZydus Pharmaceuticals USA Inc.a5ca2fce-bd2d-40db-b963-e3ec27c8bf232026-04-16Warnings, Adverse reactionsExact identifier
unii: 0H73WJJ391
topiramateTOPIRAMATEZydus Pharmaceuticals USA Inc.67dcdd6e-48bc-418e-a887-805929d83ce02026-04-15Warnings, Adverse reactionsExact identifier
rxcui: 199890
rxcui: 151226
rxcui: 199889
rxcui: 199888
unii: 0H73WJJ391
TopiramateTOPIRAMATEGlenmark Pharmaceuticals Inc., USA35312f49-decf-428d-bf5f-4215b762ed3c2026-04-10Warnings, Adverse reactionsExact identifier
rxcui: 199890
rxcui: 151226
rxcui: 199889
rxcui: 199888
unii: 0H73WJJ391
topiramateTOPIRAMATEUnichem Pharmaceuticals (USA), Inc.6ee00e82-799d-445e-b658-a9712c49a28e2026-04-06Warnings, Adverse reactionsExact identifier
rxcui: 199890
rxcui: 151226
rxcui: 199889
rxcui: 199888
unii: 0H73WJJ391
TopiramateTOPIRAMATEAdvagen Pharma Ltd48169bbc-4fb2-4bc4-9bdd-de71bf7722df2026-04-03Warnings, Adverse reactionsExact identifier
unii: 0H73WJJ391
TopiramateTOPIRAMATETeva Pharmaceuticals, Inc.4f20155f-05b9-40ec-af34-3b58aa8d60d42026-04-01Warnings, Adverse reactionsExact identifier
unii: 0H73WJJ391
Phentermine and Topiramate Extended-ReleasePHENTERMINE AND TOPIRAMATE EXTENDED-RELEASEDr.Reddys Laboratories Inc260c3f90-163d-0bdd-1099-55d18a900e682026-03-31Warnings, Adverse reactionsExact identifier
unii: 0H73WJJ391
TopiramateTOPIRAMATEZydus Pharmaceuticals USA Inc.f72774dd-c7eb-41f9-9837-02baf77cc5232026-03-30Warnings, Adverse reactionsExact identifier
unii: 0H73WJJ391
TopiramateTOPIRAMATELupin Pharmaceuticals, Inc.e310afcd-1260-434e-a994-34549c789d992026-03-30Warnings, Adverse reactionsExact identifier
unii: 0H73WJJ391
TopiramateTOPIRAMATEAurobindo Pharma Limited32b48ea0-a215-43b8-83b4-a5435a686d682026-03-24Warnings, Adverse reactionsExact identifier
rxcui: 199890
rxcui: 151226
rxcui: 199889
rxcui: 199888
unii: 0H73WJJ391
TOPIRAMATETOPIRAMATEAurobindo Pharma Limitedd1588c37-9da9-4ccb-b78a-64234938a1152026-03-24Warnings, Adverse reactionsExact identifier
unii: 0H73WJJ391

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.