FDA.reportPublic FDA data

NDC 80425-0488-01 - 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
80425-0488
Requested NDC
80425-0488-01
Package NDCs from labels
80425-0488-1, 80425-0488-3, 80425-0488-2, 80425-0488-01
Manufacturer
Advanced Rx of Tennessee, LLC
Effective date
2025-01-30
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, LLC2025-01-30HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0488-1topiramate30 in 1 BOTTLE, PLASTICTABLET, FILM COATED301
80425-0488-2topiramate60 in 1 BOTTLE, PLASTICTABLET, FILM COATED601
80425-0488-3topiramate90 in 1 BOTTLE, PLASTICTABLET, FILM COATED901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0488TOPIRAMATE TABLET, FILM COATED [ADVANCED RX OF TENNESSEE, LLC]1Current NDC, 3 package rows20250201_2cf7ce9e-afc2-f94e-e063-6394a90a35d0.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0488-1EA - Each80425-0488ef1e29b7-a571-4a06-a2a7-e2ee95ed0f1e12025-03-04
80425-0488-2EA - Each80425-04886ce3efcf-2639-498b-a074-be14d34cd9eb12025-03-04
80425-0488-3EA - Each80425-0488883fe49c-377f-48a5-9aa0-e0852deb9b3712025-03-04

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 86 of 110 · 2,195 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AMOREPACIFIC COLOR CONTROL CUSHION COMPACT NO.102ZINC OXIDE, OCTINOXATE, AND TITANIUM DIOXIDEAMOREPACIFIC CORPORATION531f60c9-c89a-46bc-8460-d01b2e838e6f2024-10-08WarningsExact identifier
unii: 15FIX9V2JP
AMOREPACIFIC COLOR CONTROL CUSHION COMPACT NO.104OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDEAMOREPACIFIC CORPORATION60964d9f-d96c-4397-b273-6b63d18867222024-10-08WarningsExact identifier
unii: 15FIX9V2JP
IOPE AIR CUSHION Cover 21 VanillaZINC OXIDE, OCTINOXATE, AND TITANIUM DIOXIDEAMOREPACIFIC CORPORATION29d6cc8d-1469-479d-a15a-e78d4e22d4a22024-10-08WarningsExact identifier
unii: 15FIX9V2JP
DermacinRx Skin Moisturizing Ultra SPF 50 SunscreenAVOBENZONE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDEPureTek Corporation86eb06cc-d63f-4500-a52e-14ef99a565322024-10-02WarningsExact identifier
unii: 15FIX9V2JP
TiZO2TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD43bec652-3f2c-4671-8a0c-c4c4a4bfcc7a2024-10-01WarningsExact identifier
unii: 15FIX9V2JP
CalamineCALAMINE AND ZINC OXIDEStrategic Sourcing Services, LLC22173332-9d09-768c-e063-6394a90a94e12024-09-14WarningsExact identifier
unii: 1K09F3G675
Proceuticals Private Label by TiZO tinted mineral sunscreen stickTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, Ltd2179a2ff-9425-5b2c-e063-6294a90a45b62024-09-06WarningsExact identifier
unii: 15FIX9V2JP
EltaMD UV Physical Rosy Tint SPF40TITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc6bc4d2d4-ef62-4ec0-b514-17257603bac22024-09-05WarningsExact identifier
unii: 15FIX9V2JP
Proceuticals Private Label by TiZO non-tinted mineral sunscreen stickTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, Ltd20e86260-d641-c9ac-e063-6394a90ac07d2024-08-30WarningsExact identifier
unii: 15FIX9V2JP
Freaks of Nature Peak Performance SPF50FREAKS OF NATURE PEAK PERFORMANCE SPF50Milbar Laboratories20b18cea-95e9-3527-e063-6294a90a4db42024-08-30WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF30TITANIUM DIOXIDE AND ZINC OXIDEDermio Dermatology LLC204973ce-dba4-8235-e063-6394a90a015c2024-08-22WarningsExact identifier
unii: 15FIX9V2JP
topiramateTOPIRAMATEA-S Medication Solutions8706a35d-5c39-4daf-b83a-65f3d630e0432024-08-21Warnings, Adverse reactionsExact identifier
application number: ANDA090162
rxcui: 199888
unii: 0H73WJJ391
TopiramateTOPIRAMATEBryant Ranch Prepack61390be3-7553-4cb5-b5da-7571ed7d4b172024-08-20Warnings, Adverse reactionsExact identifier
rxcui: 199888
unii: 0H73WJJ391
TopiramateTOPIRAMATEBryant Ranch Prepackffaacad8-4594-45a8-b292-02a84cd0c35b2024-08-20Warnings, Adverse reactionsExact identifier
rxcui: 151226
unii: 0H73WJJ391
MACKENZIES OCEAN SAFE SUNSCREENTITANIUM DIOXIDENaturally Uncommon, LLC1fd0a790-c66c-216f-e063-6294a90ae9712024-08-16WarningsExact identifier
unii: 15FIX9V2JP
TopiramateTOPIRAMATEAdvanced Rx Pharmacy of Tennessee, LLCb353e7fb-b976-96d8-e053-2995a90a110a2024-08-14Warnings, Adverse reactionsExact identifier
rxcui: 151226
unii: 0H73WJJ391
topiramateTOPIRAMATEZydus Lifesciences Limited57016639-89fe-43ad-89c4-5e7a756dddec2024-08-14Exact identifier
rxcui: 199890
rxcui: 151226
rxcui: 199889
rxcui: 199888
unii: 0H73WJJ391
Proceuticals Private Label by TiZO non-tinted foaming mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, Ltd1f4491ab-95b0-cc14-e063-6394a90a73ca2024-08-09WarningsExact identifier
unii: 15FIX9V2JP
topiramateTOPIRAMATEBryant Ranch Prepack654f7c48-8c5d-4b97-88d6-397696f82b6a2024-08-08Warnings, Adverse reactionsExact identifier
application number: ANDA090162
rxcui: 199888
unii: 0H73WJJ391
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 7.5NOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorb737146d-fb50-4ed6-ab5e-6aff3393992a2024-08-07WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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