NDC 0228-2142 - DIVALPROEX SODIUM DELAYED-RELEASE

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
0228-2142
Package NDCs from labels
0228-2142-11, 0228-2142-75
Manufacturer
ORCHID HEALTHCARE (A DIVISION OF ORCHID CHEMICALS AND PHARMACEUTICALS LTD.)
Effective date
2008-12-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
DIVALPROEX SODIUM DELAYED-RELEASE TABLETS, USPORCHID HEALTHCARE (A DIVISION OF ORCHID CHEMICALS AND PHARMACEUTICALS LTD.)2008-12-04HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0228-2142-11DIVALPROEX SODIUM DELAYED-RELEASE100 in 1 BOTTLETABLET, FILM COATED1001
0228-2142-75DIVALPROEX SODIUM DELAYED-RELEASE10 in 1 BLISTER PACKTABLET, FILM COATED101
0228-2142-75DIVALPROEX SODIUM DELAYED-RELEASE10 in 1 CARTONTABLET, FILM COATED101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0228-2142DIVALPROEX SODIUM DELAYED-RELEASE (DIVALPROEX SODIUM) TABLET, FILM COATED [ORCHID HEALTHCARE (A DIVISION OF ORCHID CHEMICALS AND PHARMACEUTICALS LTD.)]13 package rows20081211_e26005ef-77f0-4393-a2dc-b5fe460cead8.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Divalproex sodiumACTIVE INGREDIENT644VL95AO6DIVALPROEX SODIUM DELAYED-RELEASE (DIVALPROEX SODIUM) TABLET, FILM COATED [ORCHID HEALTHCARE (A DIVISION OF ORCHID CHEMICALS AND PHARMACEUTICALS LTD.)]1
Valproic acidACTIVE MOIETY614OI1Z5WIDIVALPROEX SODIUM DELAYED-RELEASE (DIVALPROEX SODIUM) TABLET, FILM COATED [ORCHID HEALTHCARE (A DIVISION OF ORCHID CHEMICALS AND PHARMACEUTICALS LTD.)]1
FD&C Blue No. 1.INACTIVE INGREDIENTH3R47K3TBDDIVALPROEX SODIUM DELAYED-RELEASE (DIVALPROEX SODIUM) TABLET, FILM COATED [ORCHID HEALTHCARE (A DIVISION OF ORCHID CHEMICALS AND PHARMACEUTICALS LTD.)]1
ferric oxideINACTIVE INGREDIENT1K09F3G675DIVALPROEX SODIUM DELAYED-RELEASE (DIVALPROEX SODIUM) TABLET, FILM COATED [ORCHID HEALTHCARE (A DIVISION OF ORCHID CHEMICALS AND PHARMACEUTICALS LTD.)]1
methacrylic acid co-polymerINACTIVE INGREDIENTDIVALPROEX SODIUM DELAYED-RELEASE (DIVALPROEX SODIUM) TABLET, FILM COATED [ORCHID HEALTHCARE (A DIVISION OF ORCHID CHEMICALS AND PHARMACEUTICALS LTD.)]1
microcrystalline celluloseINACTIVE INGREDIENTOP1R32D61UDIVALPROEX SODIUM DELAYED-RELEASE (DIVALPROEX SODIUM) TABLET, FILM COATED [ORCHID HEALTHCARE (A DIVISION OF ORCHID CHEMICALS AND PHARMACEUTICALS LTD.)]1
opacode blackINACTIVE INGREDIENTDIVALPROEX SODIUM DELAYED-RELEASE (DIVALPROEX SODIUM) TABLET, FILM COATED [ORCHID HEALTHCARE (A DIVISION OF ORCHID CHEMICALS AND PHARMACEUTICALS LTD.)]1
opadry clearINACTIVE INGREDIENTDIVALPROEX SODIUM DELAYED-RELEASE (DIVALPROEX SODIUM) TABLET, FILM COATED [ORCHID HEALTHCARE (A DIVISION OF ORCHID CHEMICALS AND PHARMACEUTICALS LTD.)]1
povidoneINACTIVE INGREDIENTFZ989GH94EDIVALPROEX SODIUM DELAYED-RELEASE (DIVALPROEX SODIUM) TABLET, FILM COATED [ORCHID HEALTHCARE (A DIVISION OF ORCHID CHEMICALS AND PHARMACEUTICALS LTD.)]1
pregelatinized starchINACTIVE INGREDIENTDIVALPROEX SODIUM DELAYED-RELEASE (DIVALPROEX SODIUM) TABLET, FILM COATED [ORCHID HEALTHCARE (A DIVISION OF ORCHID CHEMICALS AND PHARMACEUTICALS LTD.)]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4DIVALPROEX SODIUM DELAYED-RELEASE (DIVALPROEX SODIUM) TABLET, FILM COATED [ORCHID HEALTHCARE (A DIVISION OF ORCHID CHEMICALS AND PHARMACEUTICALS LTD.)]1
simethicone emulsionINACTIVE INGREDIENTDIVALPROEX SODIUM DELAYED-RELEASE (DIVALPROEX SODIUM) TABLET, FILM COATED [ORCHID HEALTHCARE (A DIVISION OF ORCHID CHEMICALS AND PHARMACEUTICALS LTD.)]1
sodium hydroxideINACTIVE INGREDIENT55X04QC32IDIVALPROEX SODIUM DELAYED-RELEASE (DIVALPROEX SODIUM) TABLET, FILM COATED [ORCHID HEALTHCARE (A DIVISION OF ORCHID CHEMICALS AND PHARMACEUTICALS LTD.)]1
talcINACTIVE INGREDIENT7SEV7J4R1UDIVALPROEX SODIUM DELAYED-RELEASE (DIVALPROEX SODIUM) TABLET, FILM COATED [ORCHID HEALTHCARE (A DIVISION OF ORCHID CHEMICALS AND PHARMACEUTICALS LTD.)]1
triethyl citrateINACTIVE INGREDIENT8Z96QXD6UMDIVALPROEX SODIUM DELAYED-RELEASE (DIVALPROEX SODIUM) TABLET, FILM COATED [ORCHID HEALTHCARE (A DIVISION OF ORCHID CHEMICALS AND PHARMACEUTICALS LTD.)]1
vanilla flavorINACTIVE INGREDIENTDIVALPROEX SODIUM DELAYED-RELEASE (DIVALPROEX SODIUM) TABLET, FILM COATED [ORCHID HEALTHCARE (A DIVISION OF ORCHID CHEMICALS AND PHARMACEUTICALS LTD.)]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 3 of 3 · 60 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Divalproex SodiumDIVALPROEX SODIUMBryant Ranch Prepack47412563-ec3e-44fd-9f3f-c00b9b09033a2025-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1099678
Divalproex SodiumDIVALPROEX SODIUMBryant Ranch Prepackcd6fe37a-d26d-4ae8-a894-b44878e6bf8e2025-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1099678
divalproex sodiumDIVALPROEX SODIUMProficient Rx LP15ffe3d8-d483-4c45-adc4-1cc8a5b68d192025-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1099678
Divalproex Sodium D/RDIVALPROEX SODIUM D/RDirect_Rx3aff8f08-d8e8-cd13-e063-6394a90aa00c2025-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1099678
Divalproex SodiumDIVALPROEX SODIUMAmerican Health Packagingca6bbec6-5631-4436-957e-fb8707e1683d2025-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1099678
rxcui: 1099870
rxcui: 1099625
Divalproex SodiumDIVALPROEX SODIUMCoupler LLC38f4f2fd-400b-ccc4-e063-6294a90a5f412025-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1099678
Divalproex SodiumDIVALPROEX SODIUMATLANTIC BIOLOGICALS CORP.57b71a0b-c2bf-4326-9c26-0f2fe56bf5bc2025-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1099678
Divalproex SodiumDIVALPROEX SODIUMBryant Ranch Prepack48a6e47a-3697-492d-9086-56e4ca0151e52025-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1099870
Divalproex SodiumDIVALPROEX SODIUMBryant Ranch Prepackc8d9cd69-ceca-3057-9d1c-12c44b19f7672025-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1099870
Divalproex SodiumDIVALPROEX SODIUMBryant Ranch Prepack0fb57229-08ef-44d6-b40a-92b2f96ff7952025-02-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1099678
Divalproex SodiumDIVALPROEX SODIUMAmerican Health Packaging64b509bc-f398-48ad-bdcb-9904e61d92252025-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1099678
rxcui: 1099870
Divalproex SodiumDIVALPROEX SODIUMNuCare Pharmaceuticals,Inc.0bef10ed-e4b5-95ae-e063-6294a90a86eb2025-01-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1099678
Divalproex SodiumDIVALPROEX SODIUMA-S Medication Solutionsc8f72850-92d5-4f64-b9f1-657f72bfa15a2024-11-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1099678
Divalproex SodiumDIVALPROEX SODIUMA-S Medication Solutions8ecfe765-d743-4308-9cd9-4a7b1a229ea92024-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1099678
Divalproex SodiumDIVALPROEX SODIUMA-S Medication Solutions63d61062-2700-47f4-8ab4-3bd641b81fe12024-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1099625
Divalproex SodiumDIVALPROEX SODIUMProficient Rx LPabac11e6-7ce1-491c-9ac3-61f3df54c4a42022-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1099678
rxcui: 1099870
divalproex sodiumDIVALPROEX SODIUMDr.Reddy's Laboratories Limited15f8a5be-e269-2e07-60d9-1dd7bf5f52812018-12-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1099678
rxcui: 1099870
rxcui: 1099625
Divalproex SodiumDIVALPROEX SODIUMAphena Pharma Solutions - Tennessee, LLCb74adc5e-e92d-46a7-afdc-a6464a440bde2018-02-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1099678
Divalproex SodiumDIVALPROEX SODIUMAphena Pharma Solutions - Tennessee, LLC9cfdcb58-d6d7-43bb-b6e1-17172b1432962018-02-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1099870
F9144D69-BB0F-E3CE-32BB-EA453EFA12F7e26005ef-77f0-4393-a2dc-b5fe460cead82008-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: F9144D69-BB0F-E3CE-32BB-EA453EFA12F7
spl set id: e26005ef-77f0-4393-a2dc-b5fe460cead8

Reported adverse events (FAERS/openFDA)#

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