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 4 of 144 · 2,868 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SmogstatECHINACEA (ANGUSTIFOLIA), HYPERICUM PERFORATUM, HYDRASTIS CANADENSIS, SYMPHYTUM OFFICINALE, ARSENICUM ALBUM, CARBO VEGETABILIS, CAUSTICUM, KALI CARBONICUM, NATRUM SULPHURICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEAEnergique, Inc.59f63e2b-24fa-43a0-8334-02e6729c6ac12026-07-31WarningsExact identifier
unii: ETJ7Z6XBU4
Muscle IcePHYTOLACCA DECANDRA, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, SYMPHYTUM OFFICINALE, MAGNESIA PHOSPHORICA, SILICEA, MENTHOL (CRYSTALS)Peaceful Mountain, Inc.03b6e2a9-f335-4ae2-9011-80bd019afb722026-07-30WarningsExact identifier
unii: ETJ7Z6XBU4
BioplasmaSILICON DIOXIDE,POTASSIUM CHLORIDE,SODIUM SULFATE,FERROSOFERRIC PHOSPHATE,MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE,SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE,TRIBASIC CALCIUM PHOSPHATE,POTASSIUM PHOSPHATE, DIBASIC,POTASSIUM SULFATE,SODIUM CHLORIDE,CALCIUM SULFATE ANHYDROUS,CALCIUM FLUORIDEHyland's Inc.dd0a7ed2-d112-4b96-e053-2995a90ac6b62026-07-30WarningsExact identifier
unii: ETJ7Z6XBU4
ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 110-COCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEBEL STAR S.A.575fb2c3-e332-8a3b-e063-6394a90a9fd92026-07-24WarningsExact identifier
unii: 15FIX9V2JP
Divalproex SodiumDIVALPROEX SODIUMREMEDYREPACK INC.0339e27d-3dbf-4c37-a14e-f53557c08e192026-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 644VL95AO6
Divalproex SodiumDIVALPROEX SODIUMMajor Pharmaceuticals4ef6c5fd-42b2-4419-9b5a-e6d63571e3a02026-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA090161
ndc (package): 0904-6363-61
ndc (package): 0904-6363-45
ndc (product): 0904-6363
rxcui: 1099563
spl id: eb833df2-e815-473b-a0bd-a2cb8e4a024c
spl set id: 4ef6c5fd-42b2-4419-9b5a-e6d63571e3a0
unii: 644VL95AO6
True Coast SPF 50 Mineral SunscreenZINC OXIDE 18%, TITANIUM DIOXIDE 6%Foshan Sugar Max Cosmetics CO.,Ltd5379466d-8d14-5fc2-e063-6394a90abd7e2026-07-22WarningsExact identifier
unii: 15FIX9V2JP
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE571f23e9-1126-e32d-e063-6294a90a99512026-07-21WarningsExact identifier
unii: 15FIX9V2JP
Divalproex SodiumDIVALPROEX SODIUMREMEDYREPACK INC.5926c3ff-c995-4789-941c-d38aa7db94dc2026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 644VL95AO6
MENS SPF50 ALL IN ONE SUNSCREENMENS SPF50 ALL IN ONE SUNSCREENLance (Guangzhou) Biological Technology Co., Ltd.57074480-77fd-cc06-e063-6294a90a28d42026-07-20WarningsExact identifier
unii: 15FIX9V2JP
Divalproex SodiumDIVALPROEX SODIUMPD-Rx Pharmaceuticals, Inc.90225548-85a8-4ea7-95d3-e8231c36fe5a2026-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 644VL95AO6
Divalproex SodiumDIVALPROEX SODIUMPD-Rx Pharmaceuticals, Inc.a67855ff-a879-43f0-bca3-94c304348bf52026-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 644VL95AO6
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc5711364c-f9b4-bfa6-e063-6294a90ace4a2026-07-20WarningsExact identifier
unii: 15FIX9V2JP
Divalproex sodiumDIVALPROEX SODIUMPD-Rx Pharmaceuticals, Inc.392df14f-4d65-4be9-973b-1f0ce1013d8f2026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1099563
unii: 644VL95AO6
PridICHTHAMMOL, CALCIUM SULFIDE, CALENDULA OFFICINALIS FLOWERING TOP, ARNICA MONTANA, ECHINACEA ANGUSTIFOLIA, SILICON DIOXIDE, SULFURHyland's Inc.49689eeb-7790-07f1-e063-6294a90a2df22026-07-16WarningsExact identifier
unii: ETJ7Z6XBU4
Leg Cramps PMOYSTER SHELL CALCIUM CARBONATE, CRUDE, CAUSTICUM, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, COPPER, LYCOPODIUM CLAVATUM SPORE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, SILICON DIOXIDE, AND SULFURHyland's Inc.b0574a7e-88fa-417e-b6d5-60ced59eba472026-07-15WarningsExact identifier
unii: ETJ7Z6XBU4
Jacksons Cell Salts SILICA 12X 12SILICEAZettl Health Inc.5647dafc-1fff-6a25-e063-6294a90a8b4f2026-07-10Exact identifier
unii: ETJ7Z6XBU4
Bombee Honey Daily Glow Shield SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDEABT ASIA Inc.56112dff-b091-7a56-e063-6294a90a77d32026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Divalproex SodiumDIVALPROEX SODIUMREMEDYREPACK INC.3b41cd15-9981-4d44-9c4b-e84168d864532026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1099563
unii: 644VL95AO6
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DERMIO DERMATOLOGY LLC562f5b0d-6a10-305d-e063-6394a90a59802026-07-08WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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