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 5 of 144 · 2,868 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30Suzanne's Skin2soul LLC562fbaa6-f93a-5ec4-e063-6294a90a96342026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Aussie Betta Tallow Sunscreen SPF50 SPF50TITANIUM DIOXIDE AND ZINC OXIDE SUNSCREENAUSSIE BETTA HEALTHY CARE PTY LTD56007d82-ff5b-6c26-e063-6294a90a09b62026-07-07WarningsExact identifier
unii: 15FIX9V2JP
Artificial TearsARTIFICIAL TEARSAvPAKf18bebf2-1936-658f-e053-2a95a90a50122026-07-07WarningsExact identifier
unii: 3NXW29V3WO
EELHOE Body Coverage PerfectorTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.5610c3b7-456b-3bc1-e063-6394a90a3fa82026-07-07WarningsExact identifier
unii: 15FIX9V2JP
Divalproex SodiumDIVALPROEX SODIUMDr. Reddy's Laboratories Ltdfa823ee0-0c69-6b85-da1e-9bb2e2150ea52026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA090070
ndc (product): 55111-534
rxcui: 1099569
spl id: 65caa41f-3e0b-c418-b098-f4d0d8d9f31d
spl set id: fa823ee0-0c69-6b85-da1e-9bb2e2150ea5
unii: 644VL95AO6
Divalproex SodiumDIVALPROEX SODIUMDr. Reddy's Laboratories Ltd2e35f833-1cf7-12eb-9567-7a191e32e1382026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA090161
ndc (package): 55111-533-79
ndc (package): 55111-533-78
ndc (package): 55111-533-30
ndc (package): 55111-533-01
ndc (package): 55111-533-05
ndc (package): 55111-533-60
ndc (product): 55111-533
ndc11 (package): 55111053379
rxcui: 1099563
spl id: 86498fa3-61af-c27e-9f94-b2a3fb6e16df
spl set id: 2e35f833-1cf7-12eb-9567-7a191e32e138
unii: 644VL95AO6
divalproex sodiumDIVALPROEX SODIUMCoupler LLC55f1614b-aadc-34ca-e063-6394a90ae2a72026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 644VL95AO6
Premier Tinted Mineral SunscreenBROAD SPECTRUM SPF30Emerald Aesthetics LLC55f88dd1-346c-22a5-e063-6294a90a711f2026-07-06WarningsExact identifier
unii: 15FIX9V2JP
Divalproex sodiumDIVALPROEX SODIUMCamber Pharmaceuticals, Inc.e8e954d4-54e3-491c-867c-b3b656b70f232026-07-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1099569
rxcui: 1099563
unii: 644VL95AO6
Divalproex SodiumDIVALPROEX SODIUMREMEDYREPACK INC.74a9f020-f7a1-44e2-a452-f0e37bd3e0772026-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA090161
ndc (package): 70518-1138-0
ndc (package): 70518-1138-2
ndc (package): 70518-1138-1
ndc (product): 70518-1138
rxcui: 1099563
spl id: 55a4938f-4b20-599f-e063-6394a90a270e
spl set id: 74a9f020-f7a1-44e2-a452-f0e37bd3e077
unii: 644VL95AO6
OHUI Ultimate Cover CC Cushion Compact 02 Natural BeigeTITANIUM DIOXIDELG H&H Co., Ltd.d307471c-6cc6-ce48-e053-2995a90a3e022026-07-02WarningsExact identifier
unii: 15FIX9V2JP
Evereden Fluid Silk Mineral Sunscreen PRO SPF50TITANIUM DIOXIDE, ZINC OXIDEEden Brands Inc.2cb7773f-9a05-ad02-e063-6294a90af0242026-07-01WarningsExact identifier
unii: 15FIX9V2JP
The Cell Salt Co. Daily Blend 12 in 1CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEAThe Cell Salt Company LLC55826f59-acf4-7370-e063-6394a90afed72026-07-01WarningsExact identifier
unii: ETJ7Z6XBU4
Divalproex SodiumDIVALPROEX SODIUMSt. Mary's Medical Park Pharmacy35a91dd3-19d0-09cb-e063-6394a90af01b2026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 644VL95AO6
Divalproex SodiumDIVALPROEX SODIUMSt. Mary's Medical Park Pharmacy35a95333-9fc1-7a9f-e063-6294a90a9f302026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 644VL95AO6
OHUI Ultimate Cover CC Cushion Compact 01 Light BeigeTITANIUM DIOXIDELG H&H Co., Ltd.d2f9c54b-ac4e-5141-e053-2a95a90aa2b82026-06-30WarningsExact identifier
unii: 15FIX9V2JP
Bambusa StannumBAMBUSA STANNUMUriel Pharmacy Inc.a0d4d0ac-e2d2-4381-8f93-e417195218592026-06-30WarningsExact identifier
unii: ETJ7Z6XBU4
Divalproex sodiumDIVALPROEX SODIUMMajor Pharmaceuticals4a0fa934-ec8c-460e-86eb-11281728fe852026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 644VL95AO6
TOCOBO Blur Finish Sun Cushion Cotton BlueHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEPICTON Co., Ltd.4d6ddee3-9a76-6c9c-e063-6394a90a15292026-06-29WarningsExact identifier
unii: 15FIX9V2JP
Earth Baby Broad Spectrum SPF 30SUNSCREENEarth Baby, Inc.42556876-74ea-38e6-e054-00144ff8d46c2026-06-28WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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