FDA.reportPublic FDA data

NDC 68382-863-30 - 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
68382-863
Requested NDC
68382-863-30
Package NDCs from labels
68382-863-05, 68382-863-01, 68382-863-16, 68382-863-06, 68382-863-30, 68382-863-78
Manufacturer
Zydus Pharmaceuticals USA Inc. | Zydus Worldwide DMCC | Zydus Lifesciences Limited
Effective date
2026-03-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Topiramate - Zydus Pharmaceuticals USA Inc. | Zydus Worldwide DMCC | Zydus Lifesciences LimitedZydus Pharmaceuticals USA Inc. | Zydus Worldwide DMCC | Zydus Lifesciences Limited2026-03-30HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68382-863-01Topiramate100 in 1 BOTTLECAPSULE, EXTENDED RELEASE10010
68382-863-05Topiramate500 in 1 BOTTLECAPSULE, EXTENDED RELEASE50010
68382-863-06Topiramate30 in 1 BOTTLECAPSULE, EXTENDED RELEASE3010
68382-863-16Topiramate90 in 1 BOTTLECAPSULE, EXTENDED RELEASE9010
68382-863-30Topiramate10 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE1010
68382-863-78Topiramate3 in 1 CARTONCAPSULE, EXTENDED RELEASE310

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-863TOPIRAMATE CAPSULE, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS USA INC.]9Current NDC, Legacy NDC, 6 package rows20250406_f72774dd-c7eb-41f9-9837-02baf77cc523.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-863-06EA - Each68382-8639d2c073b-abe6-4e7c-b893-0bc35c98764912023-02-06

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 122 · 2,434 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
TopiramateTOPIRAMATEREMEDYREPACK INC.3f99b26b-79b9-4efb-aa2c-2868e1e126c82026-09-04Warnings, Adverse reactionsExact identifier
unii: 0H73WJJ391
QUDEXY XRTOPIRAMATEUpsher-Smith Laboratories, LLC46f54677-3a22-4c38-9b92-923020164e152026-09-03Warnings, Adverse reactionsExact identifier
unii: 0H73WJJ391
topiramateTOPIRAMATEREMEDYREPACK INC.0c0a6774-e234-47a5-866e-462cfd99744c2026-09-01Warnings, Adverse reactionsExact identifier
unii: 0H73WJJ391
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
topiramateTOPIRAMATECoupler LLC59f39dea-f29b-d6c6-e063-6294a90a5b742026-08-26Warnings, Adverse reactionsExact identifier
unii: 0H73WJJ391
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
unii: 15FIX9V2JP
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.59d74e3f-e3fa-a7a9-e063-6294a90a76e52026-08-24WarningsExact identifier
unii: 15FIX9V2JP
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: 6DC9Q167V3
Rohto All-In-OneHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATEThe Mentholatum Company43e690e4-b381-46e3-838c-33aef5bdadde2026-08-20WarningsExact identifier
unii: 3NXW29V3WO
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
unii: 6DC9Q167V3
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
unii: 6DC9Q167V3
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30HAMBLIN DERMATOLOGY5942e64c-416e-7525-e063-6394a90a28392026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Protect Tinted Mineral SunscreenBROAD SPECTRUM SPF30Opal Day Spa5943413a-48e1-0bdf-e063-6294a90a2fff2026-08-17WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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