FDA.reportPublic FDA data

NDC 68084-342-11 - 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
68084-342
Requested NDC
68084-342-11
Package NDCs from labels
68084-342-11, 68084-342-01
Manufacturer
Cardinal Health 107, LLC
Effective date
2026-10-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
topiramate - Cardinal Health 107, LLCCardinal Health 107, LLC2026-10-06HUMAN PRESCRIPTION DRUG LABEL
Topiramate - American Health PackagingAmerican Health Packaging2025-09-30HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68084-342-01Topiramate100 in 1 BOX, UNIT-DOSETABLET, FILM COATED10019
68084-342-11Topiramate1 in 1 BLISTER PACKTABLET, FILM COATED119

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-342TOPIRAMATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]18Current NDC, Legacy NDC, 2 package rows20241109_1af94c80-2b17-409a-98f6-ce00f942351d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-342-01EA - Each68084-3425b9b670c-335d-4f87-994a-5a0bb43cfe0512012-07-24
68084-342-11EA - Each68084-342570d579c-f26a-41eb-b83c-3d0af27e44f912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOPIRAMATEACTIVE INGREDIENT0H73WJJ391TOPIRAMATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]9
TOPIRAMATEACTIVE MOIETY0H73WJJ391TOPIRAMATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]9
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTOPIRAMATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]9
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTOPIRAMATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]9
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTOPIRAMATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TOPIRAMATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]9
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATOPIRAMATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]9
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TOPIRAMATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]9
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TOPIRAMATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]9
TALCINACTIVE INGREDIENT7SEV7J4R1UTOPIRAMATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]9
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTOPIRAMATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]9

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 9 of 140 · 2,786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ANESSA PERFECT UV SUNSCREEN SKINCARE MILK GBZINC OXIDE OCTOCRYLENE ETHYLHEXYL SALICYLATE HOMOSALATE TITANIUM DIOXIDEHONGKONG JIAHE INTERNATIONAL HOLDING LIMITED5354af18-50c4-5fba-e063-6394a90ace392026-06-03WarningsExact identifier
unii: 15FIX9V2JP
BM Silicea Icing SugarSILICEA ICING SUGARTotal Operations Management LLC DBA:Bestmade Natural Products Micro535ba100-627f-36b4-e063-6394a90a33732026-06-03WarningsExact identifier
unii: ETJ7Z6XBU4
Rohto Digi-EyeHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDEThe Mentholatum Company5d6f37b9-b568-4cb6-92de-eb40779f3f8c2026-06-03WarningsExact identifier
unii: 3NXW29V3WO
ATOMY BB SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEATOMY CO., LTD.b0cd27ee-4917-4800-bcdf-c6e14b28c1d12026-06-02WarningsExact identifier
unii: 15FIX9V2JP
Atomy Sunscreen White Broad Spectrum SPF 50 PLUSHOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDEATOMY CO., LTD.ad0b9091-a990-45bf-93f4-d886be1bbffe2026-06-02WarningsExact identifier
unii: 15FIX9V2JP
Atomy Sunscreen Beige Broad Spectrum SPF 50 PLUSHOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDEATOMY CO., LTD.994d5680-284e-4faf-a29b-4d28f8d46e8f2026-06-02WarningsExact identifier
unii: 15FIX9V2JP
Matte Veil Tinted Broad Spectrum Sunscreen SPF 40ZINC OXIDE, TITANIUM DIOXIDEPrivate Label Skin Carea8d60212-18a7-42af-8bb3-bfcff7690a492026-06-02WarningsExact identifier
unii: 15FIX9V2JP
The Mineral Melt SPF30ZINC OXIDE, TITANIUM DIOXIDEDune Suncare Inc.2114fc3b-c8ce-45d2-8a82-4dc54f0adaf32026-06-02WarningsExact identifier
unii: 15FIX9V2JP
TopiramateTOPIRAMATESun Pharmaceutical Industries, Inc.3c909a53-ae66-4b28-a741-b60bb25a69cf2026-06-01Warnings, Adverse reactionsExact identifier
rxcui: 199890
rxcui: 151226
rxcui: 199889
rxcui: 199888
unii: 0H73WJJ391
LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS UV AIR MINERAL SERUM SUNSCREEN BROAD SPECTRUM SPF 50TITANIUM DIOXIDE AND ZINC OXIDELOreal USA Products Inca1acb789-5bf4-4447-b3c5-4a7d4d3013a72026-06-01WarningsExact identifier
unii: 15FIX9V2JP
BM Tooth RemineralizationCALC PHOS, CALC FLUOR, SILICEABM Private Limited5331dc40-2ac8-5fce-e063-6394a90a58752026-06-01WarningsExact identifier
unii: ETJ7Z6XBU4
TopiramateTOPIRAMATEPar Health USA, LLC9ac09563-5967-498c-93ae-675a7f4efc482026-05-29Warnings, Adverse reactionsExact identifier
unii: 0H73WJJ391
KIEHLS DERMATOLOGIST SOLUTIONS BETTER SCREEN MINER ALL UV SERUM BROAD SPECTRUM SPF 50 PLUS MINERAL SUNSCREENTITANIUM DIOXIDE AND ZINC OXIDELOreal USA Products Inc294e6049-12b5-4b45-ae00-8ee1d9d2a1a42026-05-29WarningsExact identifier
unii: 15FIX9V2JP
TopiramateTOPIRAMATEPar Health USA, LLC11e0924b-fbee-4ec4-b1e4-22d7683b21ee2026-05-27Warnings, Adverse reactionsExact identifier
unii: 0H73WJJ391
O HUI DAY SHIELD PERFECT SUN BLACK BROAD SPECTRUM SPF 50 SUNSCREENOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDELG H&H Co., Ltd.52ba9423-8b9b-38f7-e063-6394a90a95da2026-05-26WarningsExact identifier
unii: 15FIX9V2JP
topiramateTOPIRAMATECoupler LLC52ba9c4f-e7d0-4352-e063-6394a90af7e22026-05-26Warnings, Adverse reactionsExact identifier
rxcui: 199888
unii: 0H73WJJ391
topiramateTOPIRAMATEREMEDYREPACK INC.6f461f84-bfad-44fa-a2bd-5ea1566444b52026-05-21Warnings, Adverse reactionsExact identifier
application number: ANDA078235
rxcui: 151226
unii: 0H73WJJ391
topiramateTOPIRAMATEREMEDYREPACK INC.b7539f52-06e9-4663-b401-92f5f83653cc2026-05-21Warnings, Adverse reactionsExact identifier
application number: ANDA078235
rxcui: 199889
unii: 0H73WJJ391
Mineral SPF 30 MoisturizerMINERAL SPF 30 MOISTURIZERDont Run Out Inc (DBA: Public Goods)52462e7e-0c2c-6b64-e063-6394a90a42302026-05-21WarningsExact identifier
unii: 15FIX9V2JP
DRMTLGY Radiance PowderTITANIUM DIOXIDE, ZINC OXIDEDRMTLGY15bda8d5-8c3c-6ba5-e063-6394a90a82d92026-05-21WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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