FDA.reportPublic FDA data

NDC 70518-2391-01 - 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
70518-2391
Requested NDC
70518-2391-01
Package NDCs from labels
70518-2391-1, 70518-2391-0, 70518-2391-2, 70518-2391-3, 70518-2391-01
Manufacturer
REMEDYREPACK INC.
Effective date
2026-07-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Topiramate - REMEDYREPACK INC.REMEDYREPACK INC.2026-07-09HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2391-0Topiramate30 in 1 BOXTABLET3011
70518-2391-1Topiramate1 in 1 POUCHTABLET111
70518-2391-2Topiramate30 in 1 BLISTER PACKTABLET3011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2391TOPIRAMATE TABLET [REMEDYREPACK INC.]8Current NDC, Legacy NDC, 3 package rows20250316_b71c09c5-43dd-4d98-9ab6-0b0c99908cac.zip

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 71 of 116 · 2,314 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PowderTITANIUM DIOXIDEOxygen Development LLC08b7eeeb-09ae-ffe6-e063-6294a90aba902025-05-07WarningsExact identifier
unii: 15FIX9V2JP
unii: 1K09F3G675
Vivier Sheer SPF 30 Mineral TintedTITANIUM DIOXIDE, ZINC OXIDEVivier Pharma, Inc.e12e3bcb-4c3d-41be-8e2b-12a817c8b3672025-05-05WarningsExact identifier
unii: 15FIX9V2JP
topiramateTOPIRAMATEBryant Ranch Prepack49701840-5a32-4ac1-8b07-5c61decacb952025-05-01Warnings, Adverse reactionsExact identifier
rxcui: 199888
unii: 0H73WJJ391
topiramateTOPIRAMATEBryant Ranch Prepackbf732c34-9078-496a-8093-f68594e76fcb2025-05-01Warnings, Adverse reactionsExact identifier
rxcui: 151226
unii: 0H73WJJ391
topiramateTOPIRAMATEBryant Ranch Prepack02cac021-e135-483f-bb5d-f3696eef06822025-05-01Warnings, Adverse reactionsExact identifier
rxcui: 199889
unii: 0H73WJJ391
topiramateTOPIRAMATEBryant Ranch Prepackc320999e-b940-44d8-bf31-2fb78835ac2d2025-05-01Warnings, Adverse reactionsExact identifier
rxcui: 199890
unii: 0H73WJJ391
EltaMD UV AOX ElementsZINC OXIDE, TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Incd01756c0-1f82-4e08-b956-8000ecaddfd12025-05-01WarningsExact identifier
unii: 15FIX9V2JP
TopiramateTOPIRAMATEA-S Medication Solutionsea0bcab1-cfe1-491c-875e-8c865449557e2025-04-29Warnings, Adverse reactionsExact identifier
application number: ANDA076343
rxcui: 151226
unii: 0H73WJJ391
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 PorcelainOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS2fbf7f9d-dba7-48f9-b10e-63225e8f13992025-04-25WarningsExact identifier
unii: 15FIX9V2JP
AlgenistOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDESolazyme, Inc.4ece1847-1c94-4bf7-b936-109556a460a72025-04-22WarningsExact identifier
unii: 15FIX9V2JP
Sulwhasoo Perfecting Cushion NO.17N1 VanillaOCTINOXATE, TITANIUM DIOXIDE, AND HOMOSALATEAmorepacific Corporation3350f28e-22b4-904c-e063-6394a90a1c812025-04-21WarningsExact identifier
unii: 15FIX9V2JP
topiramateTOPIRAMATEBryant Ranch Prepack073d075d-d019-4834-b55d-9b95879149752025-04-16Warnings, Adverse reactionsExact identifier
rxcui: 151226
unii: 0H73WJJ391
TopiramateTOPIRAMATECipla USA Inc.4087eb3c-96e9-4d0a-b80b-663e1c86d2562025-04-14Warnings, Adverse reactionsExact identifier
rxcui: 199890
rxcui: 151226
rxcui: 199889
rxcui: 199888
unii: 0H73WJJ391
Cicapair Soothing Color Correcting Treatment Cica Complex Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEHave & Be Co., Ltd.32c1aba6-5e29-aba9-e063-6394a90a8e562025-04-14WarningsExact identifier
unii: 15FIX9V2JP
REPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRYOCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDECLINIQUE LABORATORIES LLC07701e11-8a7e-44c5-b46e-5b48264eacad2025-04-14WarningsExact identifier
unii: 15FIX9V2JP
TopiramateTOPIRAMATEEXELAN PHARMACEUTICALS INC.690baf58-1ec9-463e-99b7-d601362ea56b2025-04-14Warnings, Adverse reactionsExact identifier
rxcui: 199890
rxcui: 151226
rxcui: 199889
rxcui: 199888
unii: 0H73WJJ391
Smoothing Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEDANIEL BEHROOZAN MD A MEDICAL CORPORATION327246c2-9d7a-2d34-e063-6294a90a5fb72025-04-10Exact identifier
unii: 15FIX9V2JP
Clarity Rx Physical Skin Defense SPF 50ZINC OXIDE AND TITANIUM DIOXIDETopiderm, Inc.b5111012-97b9-4908-95a0-d09595f9c4d92025-04-10WarningsExact identifier
unii: 15FIX9V2JP
Tinted Mineral Sunscreen SPF 50ZINC OXIDE AND TITANIUM DIOXIDETopiderm, Inc.13e5085f-df2b-46b2-b063-e58ce43799052025-04-09WarningsExact identifier
unii: 15FIX9V2JP
TopiramateTOPIRAMATECipla USA Inc.ca4ec248-285d-4066-8f89-5ed0c538c4c92025-04-09Warnings, Adverse reactionsExact identifier
application number: ANDA076343
ndc (product): 69097-125
rxcui: 199890
rxcui: 151226
rxcui: 199889
rxcui: 199888
spl id: 71f493d9-3aaa-4b13-8057-012e96e11dbc
spl set id: ca4ec248-285d-4066-8f89-5ed0c538c4c9
unii: 0H73WJJ391

Reported adverse events (FAERS/openFDA)#

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