NDC 65862-692-10 - Extended Phenytoin Sodium

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
65862-692
Requested NDC
65862-692-10
Package NDCs from labels
65862-692-01, 65862-692-99, 65862-692-10, 65862-692-78
Manufacturer
REMEDYREPACK INC.
Effective date
2026-06-25
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Extended Phenytoin Sodium - REMEDYREPACK INC.REMEDYREPACK INC.2026-06-25HUMAN PRESCRIPTION DRUG LABEL
Extended Phenytoin Sodium - Bryant Ranch PrepackBryant Ranch Prepack2025-06-11HUMAN PRESCRIPTION DRUG LABEL
Extended Phenytoin Sodium - American Health PackagingAmerican Health Packaging2025-02-06HUMAN PRESCRIPTION DRUG LABEL
Extended Phenytoin Sodium - NCS HealthCare of KY, LLC dba Vangard LabsNCS HealthCare of KY, LLC dba Vangard Labs2024-10-18HUMAN PRESCRIPTION DRUG LABEL
Extended Phenytoin Sodium - Aurobindo Pharma LimitedAurobindo Pharma Limited2023-09-21Human Prescription Drug Label
Extended Phenytoin Sodium - A-S Medication SolutionsA-S Medication Solutions2023-02-06Human Prescription Drug Label
Extended Phenytoin Sodium - Bryant Ranch PrepackBryant Ranch Prepack2022-02-14HUMAN PRESCRIPTION DRUG LABEL
Extended Phenytoin Sodium - A-S Medication SolutionsA-S Medication Solutions2018-05-10Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-692-01Extended Phenytoin Sodium100 in 1 BOTTLECAPSULE10010
65862-692-10Extended Phenytoin Sodium10 in 1 BLISTER PACKCAPSULE1010
65862-692-78Extended Phenytoin Sodium10 in 1 CARTONCAPSULE1010
65862-692-99Extended Phenytoin Sodium1000 in 1 BOTTLECAPSULE100010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-692EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [AUROBINDO PHARMA LIMITED]10Current NDC, Legacy NDC, 4 package rows20231006_5362ea50-38a4-48b4-a85b-d634c3d8b91a.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENYTOIN SODIUMACTIVE INGREDIENT4182431BJHEXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [AUROBINDO PHARMA LIMITED]1
PHENYTOINACTIVE MOIETY6158TKW0C5EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [AUROBINDO PHARMA LIMITED]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UEXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [AUROBINDO PHARMA LIMITED]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [AUROBINDO PHARMA LIMITED]1
GELATININACTIVE INGREDIENT2G86QN327LEXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [AUROBINDO PHARMA LIMITED]1
HYPROMELLOSE 2910 (4000 MPA.S)INACTIVE INGREDIENTRN3152OP35EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [AUROBINDO PHARMA LIMITED]1
MAGNESIUM OXIDEINACTIVE INGREDIENT3A3U0GI71GEXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [AUROBINDO PHARMA LIMITED]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [AUROBINDO PHARMA LIMITED]1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TEXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [AUROBINDO PHARMA LIMITED]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [AUROBINDO PHARMA LIMITED]1
SHELLACINACTIVE INGREDIENT46N107B71OEXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [AUROBINDO PHARMA LIMITED]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JEXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [AUROBINDO PHARMA LIMITED]1
SUCROSEINACTIVE INGREDIENTC151H8M554EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [AUROBINDO PHARMA LIMITED]1
TALCINACTIVE INGREDIENT7SEV7J4R1UEXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [AUROBINDO PHARMA LIMITED]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPEXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [AUROBINDO PHARMA LIMITED]1

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 39 of 113 · 2,241 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDECLEARLY BEAUTIFUL SKIN AND ACNE CLINIC LLC35bdc7f4-4e47-ce35-e063-6294a90acf2d2025-12-15Exact identifier
unii: 15FIX9V2JP
Non Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEVIDA HEALTH & WELLNESS LLC3724cb53-0198-c604-e063-6294a90aa64b2025-12-15Exact identifier
unii: 15FIX9V2JP
Untinted Sheer DefenseTITANIUM DIOXIDE, ZINC OXIDEKristina Lerner35be50b7-a9af-29ee-e063-6394a90a45ba2025-12-15Exact identifier
unii: 15FIX9V2JP
Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEVIDA HEALTH & WELLNESS LLC3724ea3c-b018-c125-e063-6394a90a01f12025-12-15Exact identifier
unii: 15FIX9V2JP
Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEVIDA HEALTH & WELLNESS LLC37252429-d692-c05a-e063-6294a90a6af62025-12-15Exact identifier
unii: 15FIX9V2JP
BHSkin Sheer Tinted Zinc and Titanium SPF 40TITANIUM DIOXIDE, ZINC OXIDEDon Mehrabi, M.D. A Professional Medical Corporation423c7e62-ad50-0dc3-e063-6294a90ad05a2025-12-15WarningsExact identifier
unii: 15FIX9V2JP
Tined Mineral Sunscreen Whipped MousseTITANIUM DIOXIDE, ZINC OXIDEESTILO SALON & SPA LLC3699c107-d063-cc6f-e063-6394a90a6ad42025-12-15Exact identifier
unii: 15FIX9V2JP
BHSkin Sheer Tinted Zinc and Titanium SPF 40TITANIUM DIOXIDE, ZINC OXIDEDon Mehrabi, M.D. A Professional Medical Corporation44776529-3aa6-4fa3-b2ce-f624c4cf41bd2025-12-15WarningsExact identifier
unii: 15FIX9V2JP
Tined Mineral Sunscreen Whipped MousseTITANIUM DIOXIDE, ZINC OXIDEESTILO SALON & SPA LLC36999510-88f0-64fc-e063-6294a90a3d092025-12-15Exact identifier
unii: 15FIX9V2JP
Sunshade Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEBELLAGENA SKINCARE STUDIO & SPA37dec631-fdaf-fbdf-e063-6394a90a6c2b2025-12-15Exact identifier
unii: 15FIX9V2JP
Matte Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEEDIT EUROSPA, LLC37527317-0f10-d7e6-e063-6394a90a35a62025-12-15Exact identifier
unii: 15FIX9V2JP
Sunshade Mineral Stick SunscreenTITANIUM DIOXIDE, ZINC OXIDEBELLAGENA SKINCARE STUDIO & SPA37ee31be-bfda-f052-e063-6294a90ac0bb2025-12-15Exact identifier
unii: 15FIX9V2JP
Matte Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEEDIT EUROSPA, LLC3751544d-e093-3d19-e063-6394a90aefc32025-12-15Exact identifier
unii: 15FIX9V2JP
Lip CrackTITANIUM DIOXIDE, ZINC OXIDEBELLAGENA SKINCARE STUDIO & SPA37edc05c-82c3-90fe-e063-6294a90aa6012025-12-15Exact identifier
unii: 15FIX9V2JP
Sunshade Daily Sun DefenseTITANIUM DIOXIDE, ZINC OXIDEBELLAGENA SKINCARE STUDIO & SPA37ee77dc-a96a-5efa-e063-6394a90affda2025-12-15Exact identifier
unii: 15FIX9V2JP
Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEEDIT EUROSPA, LLC37521c60-2fee-861e-e063-6294a90ad69a2025-12-15Exact identifier
unii: 15FIX9V2JP
Mineral Tinted Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEJADEIA LIMITED INC35cf36c1-50c9-e848-e063-6294a90a66582025-12-15Exact identifier
unii: 15FIX9V2JP
Flash Invisible StickTITANIUM DIOXIDE, ZINC OXIDEAEON AESTHETICS LLC35d2489e-4978-4fc3-e063-6294a90adfcc2025-12-15Exact identifier
unii: 15FIX9V2JP
Flash Tinted StickTITANIUM DIOXIDE, ZINC OXIDEAEON AESTHETICS LLC35d28590-e746-7996-e063-6294a90ac7d82025-12-15Exact identifier
unii: 15FIX9V2JP
Mineral Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEJADEIA LIMITED INC35cf03f4-200a-5643-e063-6394a90a9e022025-12-15Exact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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