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 2 of 144 · 2,868 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Cerebellum Thalamus A AurmCEREBELLUM THALAMUS A AURUMUriel Pharmacy Inc.e1c395b8-9221-401f-8980-c91ff88434582026-08-17WarningsExact identifier
unii: ETJ7Z6XBU4
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30HAMBLIN DERMATOLOGY5942e64c-416e-7525-e063-6394a90a28392026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Protect Tinted Mineral SunscreenBROAD SPECTRUM SPF30Opal Day Spa5943413a-48e1-0bdf-e063-6294a90a2fff2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30MedSpa By Beauty Bar LLC5943ba3d-688e-9e9c-e063-6294a90afa9a2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30CORBY, JR., TERRY L.594443fd-8e27-4ec6-e063-6294a90a3ff02026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: B697894SGQ
unii: 3NXW29V3WO
BM BM134 DROPSARSENIC ALBUM, HYDRASTIS, MYRISTICA, NITRIC ACID, PAEONIA, RHUS TOX, SILICEABM Private Limited59023500-89be-cc76-e063-6294a90a6e022026-08-14WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM173 DROPSECHINACEA, EUPHRASIA, NATRUM MUR, RHUS TOX, SILICEA, SULPHUR, URTICA URENBM Private Limited59036ca4-e7bb-bbe7-e063-6394a90a410a2026-08-14WarningsExact identifier
unii: ETJ7Z6XBU4
Divalproex SodiumDIVALPROEX SODIUMCardinal Health 107, LLC5e59609f-d79d-414b-a6fc-7efb1ba5b2002026-08-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 644VL95AO6
divalproex sodiumDIVALPROEX SODIUMBluePoint Laboratories352b4c3c-e419-4827-9e00-febb0164e0f52026-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1099569
rxcui: 1099563
unii: 644VL95AO6
AdaptopathADENOSINUM CYCLOPHOSPHORICUM, ALPHA-LIPOICUM ACIDUM, ARGENTUM METALLICUM, AVENA SATIVA, CAPSICUM ANNUUM, CITRICUM ACIDUM, COENZYME A, CUPRUM METALLICUM, GINKGO BILOBA, GLANDULA SUPRARENALIS SUIS, GLYCYRRHIZA GLABRA, HYPOTHALAMUS (BOVINE), IODIUM, LEDUM PALUSTRE, MANGANUM ACETICUM, NADIDUM, NATRUM CARBONICUM, OLEUM MORRHUAE, PHOSPHORICUM ACIDUM, PICRICUM ACIDUM, RIBOFLAVINUM, SELENIUM METALLICUM SEPIA, SILICEA, THIAMINUM HYDROCHLORICUM, THYROIDINUM (BOVINE), VANADIUM METALLICUMEnergetix Corporation41234598-0cb5-41c2-bfbe-1c15ee9bf5022026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
Agri-ChordARSENICUM ALB, BELLADONNA, CALC CARB, CEANOTHUS, CHELIDONIUM MAJ, CUPRUM SULPH, FUMARICUM AC, GALIUM, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, KALI IOD, LYCOPODIUM, PANCREAS SUIS, PETROLEUM, PHOSPHORICUM AC, PHOSPHORUS, PHYTOLACCA, SARSAPARILLA, SILICEA, SULPHUR, THYROIDINUM, TRIFOLIUM PRAT, XANTHOXYLUM, ZINC PHOSEnergetix Corporation9eb50e9a-3528-4809-bd76-47d99ef03f0e2026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
Drainage-ToneCALCAREA IODATA, CAPSICUM ANNUUM, COENZYME A, ECHINACEA ANGUSTIFOLIA, EQUISETUM ARVENSE, HYDRASTIS CANADENSIS, NADIDUM, NITRICUM ACIDUM, OLEUM MORRHUAE, PETROSELINUM SATIVUM, PHYTOLACCA DECANDRA, SCROPHULARIA NODOSA, SILICEA, SINAPIS ALBA, THUJA OCCIDENTALIS.Energetix Corporation296b455e-27c5-4f6e-929d-c4ee75b7fb0e2026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
HypothalmapathGELSEMIUM, GINKGO, GLYCYRRHIZA, HYDROCOTYLE, HYPOTHALAMUS, PETROSELINUM, PITUITARUM POSTERIUM, PYRIDOXINUM HYDROCHLORICUM, SENNA, SILICEAEnergetix Corporation3c4e2867-4d75-416b-9f3d-e6e500e46f6f2026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
Lipo-ChordACETICUM AC, ACETYLSAL AC, ADRENOCORTICOTROPHIN, ALUMINA, ARSENICUM ALB, BORAGO, CEANOTHUS, CHELIDONIUM MAJ, CHIONANTHUS, CHLORAMPHENICOLUM, CHLORPROMAZINUM, CHOLESTERINUM, CORTISONE ACETICUM, DAMIANA, FOLLICULINUM, FUMARICUM AC, KALI IOD, LYCOPODIUM, NAT SULPHURICUM, NUX VOM, OLEUM MORRHUAE, PETROLEUM, PHENACETINUM, PHOSPHORICUM AC, PHOSPHORUS, PLUMB MET, SACCHARUM OFF, SILICEA, TARAXACUM, THYROIDINUM.Energetix Corporation5c83cbd5-46fb-48a0-a739-ff9c81e7129c2026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
Lymph-Tone IIAESCULUS HIPP, AZADIRACHTA, BARYTA CARB, BERBER VULG, BOLDO, BUFO, CALC CARB, CALC PHOS, COENZYME A, COLLINSONIA, ECHINACEA, FERRUM PHOS, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS, KREOSOTUM, NADIDUM, NAT MUR, PHOS, PHYTOLACCA, PINUS SYL, PITUITARUM POSTERIUM, PIX LIQUIDA, PULSATILLA, SILICEA, STILLINGIA, THUJA OCC.Energetix Corporationc46aa8d3-4aa5-4e07-be3d-d71abc5e24072026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DR. SAMRAO'S OFFICE58b2ca35-11ed-d848-e063-6294a90a5b372026-08-11WarningsExact identifier
unii: 15FIX9V2JP
Lymph-Tone IIIADENOSINUM CYCLOPHOSPHORICUM, ARNICA, BOLDO, CALC IOD, CALENDULA, CARTILAGO SUIS, CEANOTHUS, COENZYME A, ECHINACEA, HAMAMELIS, HEPAR SULPH CALC, HYPOTHALAMUS, NADIDUM, NAJA, NAT SULPHURICUM, PHASEOLUS, PHOS, PHYTOLACCA, PINUS SYL, PITUITARUM POSTERIUM, PYROGENIUM, SILICEA, SULPHUR, THUJA OCC, THYROIDINUM, VISCUMEnergetix Corporation4c9ae54c-ce7d-4276-add7-2922a8f0e3102026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
MetabopathADENOSINUM CYCLOPHOSPHORICUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, BERBERIS VULGARIS, CITRICUM ACIDUM, COENZYME A, DNA, FUMARICUM ACIDUM, GLYCYRRHIZA GLABRA, HEPAR SULPHURIS CALCAREUM, LAPPA MAJOR, MAGNESIA PHOSPHORICA, MANGANUM ACETICUM, NADIDUM, NATRUM MURIATICUM, NATRUM OXALACETICUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PULSATILLA, PYRIDOXINUM HYDROCHLORICUM, RHAMNUS PURSHIANA, RIBOFLAVINUM, RNA, SILICEA, SUCCINICUM ACIDUM, SULPHUR, THIAMINUM HYDROCHLORICUM,Energetix Corporation58bfe670-d308-45a2-8046-7897b62214522026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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