FDA.reportPublic FDA data

NDC 80425-0495-03 - 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
80425-0495-03
Package NDCs from labels
80425-0495-1, 80425-0495-2, 80425-0495-3, 80425-0495-03
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 1 of 111 · 2,219 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TopiramateTOPIRAMATEREMEDYREPACK INC.610d4df7-703f-4070-9adc-3e57ca05a2f12026-07-30Warnings, Adverse reactionsExact identifier
rxcui: 199889
unii: 0H73WJJ391
TopiramateTOPIRAMATEPD-Rx Pharmaceuticals, Inc.4833f2e8-16b7-406f-937a-55bc978bf92c2026-07-29Warnings, Adverse reactionsExact identifier
rxcui: 151226
unii: 0H73WJJ391
True Coast SPF 50 Mineral SunscreenZINC OXIDE 18%, TITANIUM DIOXIDE 6%Foshan Sugar Max Cosmetics CO.,Ltd5379466d-8d14-5fc2-e063-6394a90abd7e2026-07-22WarningsExact identifier
unii: 15FIX9V2JP
Droptics Dry Eye ReliefCARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80Droptics LLC29d7614b-f4b7-48e2-97c5-d1bff27731d22026-07-22WarningsExact identifier
unii: 6OZP39ZG8H
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE571f23e9-1126-e32d-e063-6294a90a99512026-07-21WarningsExact identifier
unii: 15FIX9V2JP
MENS SPF50 ALL IN ONE SUNSCREENMENS SPF50 ALL IN ONE SUNSCREENLance (Guangzhou) Biological Technology Co., Ltd.57074480-77fd-cc06-e063-6294a90a28d42026-07-20WarningsExact identifier
unii: 15FIX9V2JP
TopiramateTOPIRAMATEREMEDYREPACK INC.44095c2b-2e90-45d2-ab45-d0961c41550d2026-07-20Warnings, Adverse reactionsExact identifier
rxcui: 199889
unii: 0H73WJJ391
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc5711364c-f9b4-bfa6-e063-6294a90ace4a2026-07-20WarningsExact identifier
unii: 15FIX9V2JP
topiramateTOPIRAMATEREMEDYREPACK INC.7e0834ee-920b-496f-954d-f9d81c3ba2d62026-07-17Warnings, Adverse reactionsExact identifier
rxcui: 199889
unii: 0H73WJJ391
TopiramateTOPIRAMATEREMEDYREPACK INC.b71c09c5-43dd-4d98-9ab6-0b0c99908cac2026-07-09Warnings, Adverse reactionsExact identifier
rxcui: 199890
unii: 0H73WJJ391
TopiramateTOPIRAMATEREMEDYREPACK INC.f8aaf403-0e15-4bbb-b88b-253d934396882026-07-09Warnings, Adverse reactionsExact identifier
rxcui: 151226
unii: 0H73WJJ391
TopiramateTOPIRAMATEUnit Dose Solutions, Inc.562f3fec-489b-4662-e063-6294a90a4ea22026-07-09Warnings, Adverse reactionsExact identifier
rxcui: 199888
unii: 0H73WJJ391
Bombee Honey Daily Glow Shield SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDEABT ASIA Inc.56112dff-b091-7a56-e063-6294a90a77d32026-07-08WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25- shade BB3 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.4a233350-729a-1e0c-e063-6394a90ad48c2026-07-08WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25- shade BB9 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.4a23f72b-4c33-a100-e063-6294a90ac6322026-07-08WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25- shade BB10 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.4a241d80-b9d2-ea93-e063-6294a90ab3662026-07-08WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25- shade BB8 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.4a23f728-a824-48a6-e063-6394a90acae72026-07-08WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25- shade BB4 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.4a23653a-2481-bd15-e063-6394a90a71332026-07-08WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25- shade BB5 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.4a238f2d-efa9-01d1-e063-6294a90aae6f2026-07-08WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25- shade BB1 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.4a2105a7-6ae8-ed6e-e063-6394a90a3d072026-07-08WarningsExact identifier
unii: 15FIX9V2JP