FDA.reportPublic FDA data

NDC 55111-533-79 - Divalproex 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
55111-533
Requested NDC
55111-533-79
Package NDCs from labels
55111-533-30, 55111-533-60, 55111-533-01, 55111-533-05, 55111-533-79, 55111-533-78
Manufacturer
NCS HealthCare of KY, LLC dba Vangard Labs
Effective date
2026-09-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Divalproex Sodium - NCS HealthCare of KY, LLC dba Vangard LabsNCS HealthCare of KY, LLC dba Vangard Labs2026-09-18HUMAN PRESCRIPTION DRUG LABEL
Divalproex Sodium - Major PharmaceuticalsMajor Pharmaceuticals2026-07-23HUMAN PRESCRIPTION DRUG LABEL
Divalproex Sodium - Dr. Reddy's Laboratories Ltd | Dr. Reddy's Laboratories Limite - FTO 3Dr. Reddy's Laboratories Ltd | Dr. Reddy's Laboratories Limite - FTO 32026-07-07HUMAN PRESCRIPTION DRUG LABEL
Divalproex Sodium - REMEDYREPACK INC.REMEDYREPACK INC.2026-07-02HUMAN PRESCRIPTION DRUG LABEL
Divalproex Sodium - Coupler LLCCoupler LLC2026-06-01HUMAN PRESCRIPTION DRUG LABEL
Divalproex Sodium - REMEDYREPACK INC.REMEDYREPACK INC.2022-06-10HUMAN PRESCRIPTION DRUG LABEL
Divalproex Sodium - Safecor Health, LLCSafecor Health, LLC2022-01-26HUMAN PRESCRIPTION DRUG LABEL
Divalproex Sodium - A-S Medication SolutionsA-S Medication Solutions2018-08-07HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55111-533-01Divalproex Sodium100 in 1 BOTTLETABLET, EXTENDED RELEASE10027
55111-533-05Divalproex Sodium500 in 1 BOTTLETABLET, EXTENDED RELEASE50027
55111-533-30Divalproex Sodium30 in 1 BOTTLETABLET, EXTENDED RELEASE3027
55111-533-60Divalproex Sodium60 in 1 BOTTLETABLET, EXTENDED RELEASE6027
55111-533-78Divalproex Sodium10 in 1 CARTONTABLET, EXTENDED RELEASE1027
55111-533-79Divalproex Sodium10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE1027

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-533DIVALPROEX SODIUM TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LTD]26Current NDC, Legacy NDC, 6 package rows20250504_2e35f833-1cf7-12eb-9567-7a191e32e138.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-533-01EA - Each55111-533c478261d-9125-44ed-a3a2-b737d3373d9312013-09-04
55111-533-05EA - Each55111-533d4335507-dcdd-4e0d-bb88-c4efff7d82e612013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
divalproex sodiumACTIVE INGREDIENT644VL95AO6DIVALPROEX SODIUM TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LTD]12
valproic acidACTIVE MOIETY614OI1Z5WIDIVALPROEX SODIUM TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LTD]12
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UDIVALPROEX SODIUM TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LTD]12
hydroxyethyl cellulose (2000 CPS AT 1%)INACTIVE INGREDIENTS38J6RZN16DIVALPROEX SODIUM TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LTD]12
hypromellosesINACTIVE INGREDIENT3NXW29V3WODIVALPROEX SODIUM TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LTD]12
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XDIVALPROEX SODIUM TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LTD]12
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQDIVALPROEX SODIUM TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LTD]12
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4DIVALPROEX SODIUM TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LTD]12
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPDIVALPROEX SODIUM TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LTD]12
DIVALPROEX SODIUMACTIVE INGREDIENT644VL95AO6DIVALPROEX SODIUM TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]4
VALPROIC ACIDACTIVE MOIETY614OI1Z5WIDIVALPROEX SODIUM TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIVALPROEX SODIUM TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]4
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)INACTIVE INGREDIENTS38J6RZN16DIVALPROEX SODIUM TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODIVALPROEX SODIUM TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDIVALPROEX SODIUM TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]4
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQDIVALPROEX SODIUM TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIVALPROEX SODIUM TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDIVALPROEX SODIUM TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]4

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 7 of 144 · 2,868 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Divalproex SodiumDIVALPROEX SODIUMUnit Dose Solutions, Inc.547d8305-bfc5-f4da-e063-6294a90a61062026-06-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 644VL95AO6
Divalproex SodiumDIVALPROEX SODIUMCardinal Health 107, LLC4fc50afb-67f3-4bf3-9ec3-cc12734f47fd2026-06-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 644VL95AO6
GlowBiotics Tinted Sunscreen SPF 30ZINC OXIDERum Brands, LLC544dba29-4785-4ab6-e063-6394a90a17b32026-06-16WarningsExact identifier
unii: 15FIX9V2JP
Societe Prime and DefendZINC OXIDE SUNSCREENSociete Clinical Skincare5439bd31-5ee1-9bca-e063-6394a90a748c2026-06-16WarningsExact identifier
unii: 15FIX9V2JP
Societe CoverShield Tinted SPFZINC OXIDESociete Clinical Skincare545efbc4-82d4-f126-e063-6294a90a97102026-06-16WarningsExact identifier
unii: 15FIX9V2JP
H-Scars FormulaCALENDULA OFFICINALLIS, SILICEAHealing Natural Oils LLC8433ff00-d815-45e0-b0ec-1448668dd8f82026-06-16WarningsExact identifier
unii: ETJ7Z6XBU4
Divalproex sodiumDIVALPROEX SODIUMNorthStar Rx LLCaab6b411-11e9-4a16-afb6-d471ba4756e92026-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1099569
rxcui: 1099563
unii: 644VL95AO6
E-Z-GAS IIANTACID/ANTIFLATULENTE-Z-EM, INC.4e12e1cb-b033-076d-e054-00144ff8d46c2026-06-15WarningsExact identifier
unii: ETJ7Z6XBU4
Shield by HEALTHY SKIN LAB MD SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEHEALTHY SKIN LAB LIMITED6838b754-9915-48ff-af35-5338dbd06ac42026-06-15WarningsExact identifier
unii: 15FIX9V2JP
BM BIO28 ALCOHOLCALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro544b66c4-49df-556f-e063-6394a90af3ed2026-06-15WarningsExact identifier
unii: ETJ7Z6XBU4
Divalproex sodiumDIVALPROEX SODIUMAphena Pharma Solutions - Tennessee, LLC41e32cd5-1393-4ef1-81cb-8e3795e306822026-06-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1099569
unii: 644VL95AO6
SFL SUNSCREEN - SOL DEFENSE SPF 30TITANIUM DIOXIDE, ZINC OXIDELifeline Medical, Inc5438c185-31c9-c51e-e063-6394a90ae9ef2026-06-14WarningsExact identifier
unii: 15FIX9V2JP
BM Tooth RemineralizationCALC PHOS, CALC FLUOR, SILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro543bc298-ec32-38e9-e063-6394a90aac152026-06-14WarningsExact identifier
unii: ETJ7Z6XBU4
Nail Fungus Control Extra StrengthCALENDULA OFFICINALIS FLOWERING TOP, SILICON DIOXIDE, AND HYPERICUM PERFORATUMForces of Natured02b88a6-1999-4dcd-91b5-fad88a664fcb2026-06-14WarningsExact identifier
unii: ETJ7Z6XBU4
Nerve PainARABICA COFFEE BEAN, SILICON DIOXIDE, AND HYPERICUM PERFORATUMForces of Naturea9c3ba2e-9254-4ccd-9fe9-7a360fdf2bb72026-06-14WarningsExact identifier
unii: ETJ7Z6XBU4
Scar ControlCALENDULA OFFICINALIS FLOWERING TOP, ALLYLTHIOUREA, AND SILICON DIOXIDEForces of Nature595c3423-6b52-48fc-8a95-00b53c1ecc7b2026-06-14WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM186 DROPSARNICA, FERR PHOS, HYPERICUM, IGNATIA, SILICATotal Operations Management LLC DBA:Bestmade Natural Products Micro54243745-bd67-19c1-e063-6394a90a4b722026-06-13WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM186 DROPSARNICA, FERR PHOS, HYPERICUM, IGNATIA, SILICABM Private Limited540d8fbe-3bdb-1b54-e063-6394a90a114d2026-06-12WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM5 DROPSAPIS MELL, BAPTISIA, CONIUM MAC, ECHINACEA, EUPATORIUM PERF, SILICEA, THUJA OCCTotal Operations Management LLC DBA:Bestmade Natural Products Micro540e4ee3-596f-4cea-e063-6294a90a6a602026-06-12WarningsExact identifier
unii: ETJ7Z6XBU4
Sunbetter Daily Mineral Protection Broad Spectrum SPF 75 SunscreenTITANIUM DIOXIDE AND ZINC OXIDESKINBETTER SCIENCE LLC54106748-9810-d3ff-e063-6394a90a5b7a2026-06-12WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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