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 15 of 114 · 2,274 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Perfect Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESKIN PERFECT MEDICAL4b47e7cb-17d6-6a7c-e063-6294a90abbea2026-02-20WarningsExact identifier
unii: 15FIX9V2JP
Allay Skin Solutions Protect Nourish Mineral Sunscreen SPF 42TITANIUM DIOXIDE, ZINC OXIDEALLAY SKIN SOLUTIONS LLC425bf1d7-f2cf-4237-9047-dd53054acd1c2026-02-18WarningsExact identifier
unii: 15FIX9V2JP
Hermes Plein Air-Baume de Teint Perfecteur Naturel-Enhancing Complexion Balm 85 TAMARINTITANIUM DIOXIDES.A. COMPTOIR NOUVEAU DE LA PARFUMERIEdacff3dc-49d7-6416-e053-2a95a90a85c62026-02-18WarningsExact identifier
unii: 15FIX9V2JP
AfloraMULTIVITAMINOncora Pharma, LLC38e463d1-f608-7cb5-e063-6294a90a4abb2026-02-12Warnings, Adverse reactionsExact identifier
unii: 3A3U0GI71G
FolixiaMULTIVITAMINOncora Pharma, LLC413945b5-116b-d8b6-e063-6394a90a55e82026-02-12Warnings, Adverse reactionsExact identifier
unii: 3A3U0GI71G
NutralynMULTIVITAMINOncora Pharma, LLC33da017b-1e8c-d41c-e063-6394a90aab8c2026-02-12Warnings, Adverse reactionsExact identifier
unii: 3A3U0GI71G
FolatenMULTIVITAMINOncora Pharma, LLC93086235-2c33-424d-b0c3-2130319885812026-02-12Warnings, Adverse reactionsExact identifier
unii: 3A3U0GI71G
Alumier MD Clear Shield Broad Spectrum SPF 42 SunscreenTITANIUM DIOXIDE, ZINC OXIDEAlumier Labsa9c970c8-b6e3-b0a1-e053-2a95a90a89c72026-02-09WarningsExact identifier
unii: 15FIX9V2JP
Droptics Performance Eye DropsNAPHAZOLINE HYDROCHLORIDE, PROPYLENE GLYCOLDroptics LLC20fd6822-a7fd-4593-92bb-0a07260893e22026-02-09WarningsExact identifier
unii: 6DC9Q167V3
Hampton Sun SPF 50 MineralZINC OXIDE 19.5% TITANIUM DIOXIDE 4.00%S&C Hampton Sun LLCd6c33436-042e-44e8-8b55-98be6e2468792026-02-06WarningsExact identifier
unii: 15FIX9V2JP
SHISEIDO WASO COLOR-SMART DAY MOISTURIZEROCTINOXATE, TITANIUM DIOXIDEShiseido Americas Corporationf291f077-1c72-48fc-bb19-c20bdeaaa5962026-02-06WarningsExact identifier
unii: 15FIX9V2JP
SHISEIDO WASO COLOR-SMART DAY MOISTURIZEROCTINOXATE, TITANIUM DIOXIDEShiseido Americas Corporation54f63dd8-e77f-42e4-a6d3-61ab7beecf502026-02-06WarningsExact identifier
unii: 15FIX9V2JP
SEYTU Body SunscreenTITANIUM DIOXIDE AND ZINC OXIDEOmnilife USA, Inc.c411e9a6-b2ea-446b-a886-b92c61736e6c2026-02-05WarningsExact identifier
unii: 15FIX9V2JP
SEYTU Facial SunscreenTITANIUM DIOXIDE AND ZINC OXIDEOmnilife USA, Inc.96fd37fb-c3ff-413f-b2c8-50754f320ecc2026-02-05WarningsExact identifier
unii: 15FIX9V2JP
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 BambooOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SASebfe03e7-614f-44b1-b1f1-78edc7e274cc2026-02-05WarningsExact identifier
unii: 15FIX9V2JP
SHISEIDO URBAN ENVIRONMENT oil-free MINERAL SUNSCREEN SPF 42TITANIUM DIOXIDE AND ZINC OXIDESHISEIDO AMERICAS CORPORATION86630e82-f249-4866-82dd-3e21feb266c42026-02-04WarningsExact identifier
unii: 15FIX9V2JP
Dr.Oracle AIR FIT DEFENSE SOOTHING SUNSCREENHOMOSALATE, OCTYL SALICYLATE, TITANIUM DIOXIDE, ZINC OXIDEOracle Cosmetic Co., Ltd.21424f78-f8d5-6a9b-e063-6294a90ab7dc2026-02-02WarningsExact identifier
unii: 15FIX9V2JP
Phenytoin SodiumPHENYTOIN SODIUMProficient Rx LPf4353734-29b0-4027-824d-2fc97f778c672026-02-01Warnings, Adverse reactionsExact identifier
rxcui: 855671
unii: 4182431BJH
Reef safe unscented SPF 50 mineral sunscreen 01TITANIUM DIOXIDE, ZINC OXIDECosmuses Cosmetics (Ningbo) Co., Ltd.49a77ad4-508c-9617-e063-6394a90a56232026-01-30WarningsExact identifier
unii: 15FIX9V2JP
JOSIE MARAN ARGAN SUN MILK MINERAL SUNSCREEN BROAD SPECTRUM SPF 33TITANIUM DIOXIDE AND ZINC OXIDECosmetic Solutions LLCd65ae1c9-dff5-4612-b8be-fa59bba03b812026-01-30WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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