FDA.reportPublic FDA data

NDC 80425-0495-01 - 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
80425-0495
Requested NDC
80425-0495-01
Package NDCs from labels
80425-0495-1, 80425-0495-2, 80425-0495-3, 80425-0495-01
Manufacturer
Advanced Rx of Tennessee, LLC
Effective date
2025-03-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
topiramate - Advanced Rx of Tennessee, LLCAdvanced Rx of Tennessee, LLC2025-03-20HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0495-1topiramate30 in 1 BOTTLE, PLASTICTABLET, FILM COATED301
80425-0495-2topiramate60 in 1 BOTTLE, PLASTICTABLET, FILM COATED601
80425-0495-3topiramate90 in 1 BOTTLE, PLASTICTABLET, FILM COATED901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0495TOPIRAMATE TABLET, FILM COATED [ADVANCED RX OF TENNESSEE, LLC]1Current NDC, 3 package rows20250322_30ca2fce-4e4c-439e-e063-6294a90af076.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0495-1EA - Each80425-04952da220a8-f666-4d97-95c2-1d5fc82b1c9c12025-05-14
80425-0495-2EA - Each80425-0495cfc77618-4d96-4e27-8ca8-f6aa9bae8f5812025-05-14
80425-0495-3EA - Each80425-0495709ac46c-7c41-409a-8f99-b0e48219e1bc12025-05-14

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 4 of 109 · 2,170 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Coral Isle SPF 50 Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDERocky Mountain5515f562-62d9-c6ee-e063-6294a90a9ea62026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Delicate Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc551928b4-74bb-3f6c-e063-6294a90a6b832026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Alabaster Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc5519290c-b040-6a37-e063-6394a90a8a1d2026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Soft Bisque Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc551ab7d1-dd2f-c6d8-e063-6394a90aff652026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Alabaster Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc551b8c21-3afc-c804-e063-6294a90a51562026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Bare Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f20b2-9a2e-70f3-e063-6394a90a93372026-06-25WarningsExact identifier
unii: 15FIX9V2JP
TopiramateTOPIRAMATEBryant Ranch Prepack47ef2964-3a41-4bfd-86fb-d44560b9961f2026-06-24Warnings, Adverse reactionsExact identifier
rxcui: 199890
unii: 0H73WJJ391
topiramateTOPIRAMATEBryant Ranch Prepack8abe45eb-cc75-4625-ae3d-5b2a038c49072026-06-24Warnings, Adverse reactionsExact identifier
rxcui: 199890
unii: 0H73WJJ391
TopiramateTOPIRAMATEBryant Ranch Prepack484c132f-3d3d-4218-b22f-82e9b56cc2f42026-06-24Warnings, Adverse reactionsExact identifier
rxcui: 199889
unii: 0H73WJJ391
BROAD SPECTRUM SPF 50 UNIVERSAL TINTED SUNSCREENTITANIUM DIOXIDEShantou Woodsleep Biotechnology Co., Ltd.54fc80b7-8f6c-e2be-e063-6394a90a4b592026-06-24WarningsExact identifier
unii: 15FIX9V2JP
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
Cerave Developed with Dermatologists Hydrating Sunscreen SPF 30 Body Lightweight, non-greasy feel 3 essential ceramides Mineral SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc54ecaea7-dafe-9694-e063-6394a90ae3b52026-06-23WarningsExact identifier
unii: 15FIX9V2JP
RYDEEN UV CLEARSUNSCREENGuangzhou Oupeng Cosmetics Co., Ltd.548000cd-1655-aeb3-e063-6294a90ad0042026-06-22WarningsExact identifier
unii: 15FIX9V2JP
Good Instincts Proper Sunscreen SPF 50ZINC OXIDE, TITANIUM DIOXIDEInhabit Brands, Inc82d2af99-7c42-4ce5-94e0-b2ac60b8db1b2026-06-22WarningsExact identifier
unii: 15FIX9V2JP
ESPOIR BE VELVET COVER CUSHIONHOMOSALATE, TITANIUM DIOXIDEESPOIR Corporation54ce2420-4ac0-eb51-e063-6294a90a2de92026-06-21WarningsExact identifier
unii: 15FIX9V2JP
BABIES KIDSSUN PROTECTIONMINERAL SUNSCREENPANERGYTEK USA INC3a554118-b71d-a844-e063-6294a90a699f2026-06-20WarningsExact identifier
unii: 15FIX9V2JP
Rohto Cool ReliefNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companydc8f1ff3-87ae-47ca-815f-5a0e34f8cf302026-06-19WarningsExact identifier
unii: 6OZP39ZG8H

Reported adverse events (FAERS/openFDA)#

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