FDA.reportPublic FDA data

NDC 80425-0288-01 - 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
80425-0288
Requested NDC
80425-0288-01
Package NDCs from labels
80425-0288-1, 80425-0288-2, 80425-0288-3, 80425-0288-4, 80425-0288-01
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
80425-0288-1Topiramate30 in 1 BOTTLETABLET, FILM COATED303
80425-0288-2Topiramate60 in 1 BOTTLETABLET, FILM COATED603
80425-0288-3Topiramate90 in 1 BOTTLETABLET, FILM COATED903
80425-0288-4Topiramate270 in 1 BOTTLETABLET, FILM COATED2703

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0288TOPIRAMATE TABLET, FILM COATED [ADVANCED RX PHARMACY OF TENNESSEE, LLC]3Current NDC, 4 package rows20250102_f781ada8-f90d-b233-e053-6394a90a87ff.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0288-1EA - Each80425-02889fbfba24-cf2a-4e1a-80a5-67637f87c9c712023-04-07
80425-0288-2EA - Each80425-028836543b72-ad68-45cd-9599-fb59429f30b512023-04-07
80425-0288-3EA - Each80425-028800c10f76-0d12-4caa-9194-58853a5a9c3612023-04-07
80425-0288-4EA - Each80425-0288a332c281-bc27-4da9-9192-db431088f37112023-09-05

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 2 of 8 · 147 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TopiramateTOPIRAMATEBryant Ranch Prepack484c132f-3d3d-4218-b22f-82e9b56cc2f42026-06-24Warnings, Adverse reactionsExact identifier
rxcui: 199889
unii: 0H73WJJ391
topiramateTOPIRAMATEBryant Ranch Prepackbffcd213-4f09-4a5b-8ccb-591a68be402b2026-06-24Warnings, Adverse reactionsExact identifier
rxcui: 199889
unii: 0H73WJJ391
topiramateTOPIRAMATEBryant Ranch Prepack57462baf-2f32-4bde-9627-2214c8af93702026-06-24Warnings, Adverse reactionsExact identifier
rxcui: 199888
unii: 0H73WJJ391
topiramateTOPIRAMATEBryant Ranch Prepackca9ce6c1-5a60-467a-9ad5-acc7a9f8ca152026-06-24Warnings, Adverse reactionsExact identifier
rxcui: 151226
unii: 0H73WJJ391
topiramateTOPIRAMATEBryant Ranch Prepack12cd9be8-c5c2-4a16-9164-87963e22a88e2026-06-24Warnings, Adverse reactionsExact identifier
application number: ANDA090162
rxcui: 199889
unii: 0H73WJJ391
TopiramateTOPIRAMATEUpsher-Smith Laboratories, LLCe0d88f34-865c-441b-80e2-e814c9a7d6702026-06-18Warnings, Adverse reactionsExact identifier
unii: 0H73WJJ391
topiramateTOPIRAMATECoupler LLC5461f33d-eaef-dce3-e063-6294a90aeff82026-06-16Warnings, Adverse reactionsExact identifier
rxcui: 199888
unii: 0H73WJJ391
TOPIRAMATETOPIRAMATEKesin Pharma4e914420-a65b-98ba-e063-6394a90a14c42026-06-16Warnings, Adverse reactionsExact identifier
unii: 0H73WJJ391
topiramateTOPIRAMATEAvPAK53c3f980-f05b-c671-e063-6294a90a77d52026-06-09Warnings, Adverse reactionsExact identifier
rxcui: 199890
rxcui: 151226
rxcui: 199889
rxcui: 199888
unii: 0H73WJJ391
TopiramateTOPIRAMATEPD-Rx Pharmaceuticals, Inc.1b847969-2124-4350-94b0-ef5ba707673b2026-06-08Warnings, Adverse reactionsExact identifier
rxcui: 151226
unii: 0H73WJJ391
TopiramateTOPIRAMATEPD-Rx Pharmaceuticals, Inc.021005ab-6a00-40d8-9aee-20c91613b4d52026-06-08Warnings, Adverse reactionsExact identifier
rxcui: 199888
unii: 0H73WJJ391
TopiramateTOPIRAMATESun Pharmaceutical Industries, Inc.3c909a53-ae66-4b28-a741-b60bb25a69cf2026-06-01Warnings, Adverse reactionsExact identifier
rxcui: 199890
rxcui: 151226
rxcui: 199889
rxcui: 199888
unii: 0H73WJJ391
TopiramateTOPIRAMATEPar Health USA, LLC9ac09563-5967-498c-93ae-675a7f4efc482026-05-29Warnings, Adverse reactionsExact identifier
unii: 0H73WJJ391
TopiramateTOPIRAMATEPar Health USA, LLC11e0924b-fbee-4ec4-b1e4-22d7683b21ee2026-05-27Warnings, Adverse reactionsExact identifier
unii: 0H73WJJ391
topiramateTOPIRAMATECoupler LLC52ba9c4f-e7d0-4352-e063-6394a90af7e22026-05-26Warnings, Adverse reactionsExact identifier
application number: ANDA090162
rxcui: 199888
unii: 0H73WJJ391
topiramateTOPIRAMATEREMEDYREPACK INC.6f461f84-bfad-44fa-a2bd-5ea1566444b52026-05-21Warnings, Adverse reactionsExact identifier
rxcui: 151226
unii: 0H73WJJ391
topiramateTOPIRAMATEREMEDYREPACK INC.b7539f52-06e9-4663-b401-92f5f83653cc2026-05-21Warnings, Adverse reactionsExact identifier
rxcui: 199889
unii: 0H73WJJ391
topiramateTOPIRAMATEREMEDYREPACK INC.5ce65b7f-9215-47a8-a784-f87a810bd7e42026-05-19Warnings, Adverse reactionsExact identifier
rxcui: 199888
unii: 0H73WJJ391
topiramateTOPIRAMATEREMEDYREPACK INC.2f5b1b0b-fd8a-4c4e-a85a-519ca841a0db2026-05-19Warnings, Adverse reactionsExact identifier
rxcui: 151226
unii: 0H73WJJ391
phentermine and topiramatePHENTERMINE AND TOPIRAMATEPrasco Laboratories876bd763-13fa-481e-b579-c2fc44dbf3c22026-05-18Warnings, Adverse reactionsExact identifier
unii: 0H73WJJ391

Reported adverse events (FAERS/openFDA)#

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