FDA.reportPublic FDA data

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 36 of 113 · 2,241 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Essential Brazilian Spa LLC3bc8593d-fc6c-04aa-e063-6394a90a6d562025-12-15WarningsExact identifier
unii: 15FIX9V2JP
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEMantra Wellness Spa3389b0a3-40f9-b411-e063-6394a90a99592025-12-15Exact identifier
unii: 15FIX9V2JP
Non Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEMILESTHETICS LLC39959db9-5ee1-a27c-e063-6394a90a1e102025-12-15Exact identifier
unii: 15FIX9V2JP
Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEMILESTHETICS LLC3995f556-20fe-3e64-e063-6294a90a5efe2025-12-15Exact identifier
unii: 15FIX9V2JP
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEMILESTHETICS LLC3995385b-b10b-ca5c-e063-6294a90af43f2025-12-15Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEMILESTHETICS LLC3994aa84-30b4-3dc4-e063-6394a90a23e72025-12-15Exact identifier
unii: 15FIX9V2JP
Non Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEMILESTHETICS LLC39947913-f1cc-25d2-e063-6294a90a42292025-12-15Exact identifier
unii: 15FIX9V2JP
Solar Shield TintedTITANIUM DIOXIDE, ZINC OXIDEDENISE BELL SKIN CARE396eb781-5947-3665-e063-6294a90a38dd2025-12-15Exact identifier
unii: 15FIX9V2JP
Mineral Primer tinted SPF40TITANIUM DIOXIDE, ZINC OXIDEOracle Esthetics, LLC3542d8d3-35a3-7d63-e063-6394a90a6fd12025-12-15Exact identifier
unii: 15FIX9V2JP
Mineral Primer non-tinted SPF40TITANIUM DIOXIDE, ZINC OXIDEOracle Esthetics, LLC354357de-1a85-3bdb-e063-6294a90aa9a22025-12-15Exact identifier
unii: 15FIX9V2JP
Mineral Primer tinted SPF40TITANIUM DIOXIDE, ZINC OXIDEOracle Esthetics, LLC35433254-1dc8-a8f3-e063-6394a90a29f02025-12-15Exact identifier
unii: 15FIX9V2JP
Complexion Correction Primer Sunscreen clearTITANIUM DIOXIDE, ZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY357eee3c-1c21-5efb-e063-6294a90a4bb72025-12-15Exact identifier
unii: 15FIX9V2JP
Complexion Correction Tinted Primer SunscreenTITANIUM DIOXIDE, ZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY357e75ec-473e-df76-e063-6294a90a70c72025-12-15Exact identifier
unii: 15FIX9V2JP
Complexion Correction Tinted Primer SunscreenTITANIUM DIOXIDE, ZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY357f2f62-904a-2234-e063-6394a90aee722025-12-15Exact identifier
unii: 15FIX9V2JP
Complexion Correction Primer Sunscreen clearTITANIUM DIOXIDE, ZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY357ff025-84ad-6d77-e063-6394a90aad952025-12-15Exact identifier
unii: 15FIX9V2JP
Complexion Correction Tinted Primer SunscreenTITANIUM DIOXIDE, ZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY358021a2-235b-825b-e063-6394a90a76f52025-12-15Exact identifier
unii: 15FIX9V2JP
Tinted Physical DefenseTITANIUM DIOXIDE, ZINC OXIDEATLANTA DERMOTOLOGY VEIN & RESEARCH CENTER35477ed2-0875-58d5-e063-6294a90a3d5d2025-12-15Exact identifier
unii: 15FIX9V2JP
Tinted Facial SunscreenTITANIUM DIOXIDE, ZINC OXIDEHELTON SKIN & LASER INSTITUTE35a97770-2db9-99aa-e063-6294a90a459a2025-12-15Exact identifier
unii: 15FIX9V2JP
Non-Tinted Sports StickTITANIUM DIOXIDE, ZINC OXIDEHELTON SKIN & LASER INSTITUTE35aa833a-19a1-99e9-e063-6394a90a840f2025-12-15Exact identifier
unii: 15FIX9V2JP
Tinted Facial PrimerTITANIUM DIOXIDE, ZINC OXIDEBEE NATURALS36c3352e-fa51-19ad-e063-6394a90a591b2025-12-15Exact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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