NDC 0228-2142-75 - 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
Requested NDC
0228-2142-75
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 1 of 3 · 60 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Divalproex SodiumDIVALPROEX SODIUMCardinal Health 107, LLC5e59609f-d79d-414b-a6fc-7efb1ba5b2002026-08-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1099678
rxcui: 1099870
Divalproex SodiumDIVALPROEX SODIUMREMEDYREPACK INC.bb94bbb1-07c1-49be-8c2c-f5635c65366d2026-08-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1099678
Divalproex SodiumDIVALPROEX SODIUMREMEDYREPACK INC.0339e27d-3dbf-4c37-a14e-f53557c08e192026-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1099870
Divalproex SodiumDIVALPROEX SODIUMREMEDYREPACK INC.5926c3ff-c995-4789-941c-d38aa7db94dc2026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1099678
Divalproex SodiumDIVALPROEX SODIUMPD-Rx Pharmaceuticals, Inc.90225548-85a8-4ea7-95d3-e8231c36fe5a2026-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1099678
Divalproex SodiumDIVALPROEX SODIUMPD-Rx Pharmaceuticals, Inc.a67855ff-a879-43f0-bca3-94c304348bf52026-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1099870
divalproex sodiumDIVALPROEX SODIUMCoupler LLC55f1614b-aadc-34ca-e063-6394a90ae2a72026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1099678
Divalproex SodiumDIVALPROEX SODIUMSt. Mary's Medical Park Pharmacy35a91dd3-19d0-09cb-e063-6394a90af01b2026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1099678
Divalproex SodiumDIVALPROEX SODIUMSt. Mary's Medical Park Pharmacy35a95333-9fc1-7a9f-e063-6294a90a9f302026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1099870
Divalproex SodiumDIVALPROEX SODIUMUnit Dose Solutions, Inc.547d8305-bfc5-f4da-e063-6294a90a61062026-06-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1099678
rxcui: 1099870
Divalproex SodiumDIVALPROEX SODIUMCardinal Health 107, LLC4fc50afb-67f3-4bf3-9ec3-cc12734f47fd2026-06-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1099870
Divalproex SodiumDIVALPROEX SODIUMREMEDYREPACK INC.a999f402-be1d-4153-b743-cfdb95ed15622026-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1099625
Divalproex SodiumDIVALPROEX SODIUMA-S Medication Solutions79132bea-04d8-4dd9-bd31-07f0ba805c212026-05-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1099625
Divalproex SodiumDIVALPROEX SODIUMREMEDYREPACK INC.beba3da1-e80d-45b4-9bd6-3ed85c9482f32026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1099870
Divalproex SodiumDIVALPROEX SODIUMBluePoint Laboratoriesb95494e2-ee7a-7415-e053-2995a90ae8522026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1099678
rxcui: 1099870
rxcui: 1099625
Divalproex SodiumDIVALPROEX SODIUMRising Pharma Holdings, Inc.6316061c-9758-4f38-9cb2-7ca833dd20bf2026-05-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1099678
rxcui: 1099870
rxcui: 1099625
Divalproex SodiumDIVALPROEX SODIUMLupin Pharmaceuticals, Inc.33798a7c-c5a9-49a5-be5d-1312910ef4682026-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1099678
rxcui: 1099870
rxcui: 1099625
Divalproex SodiumDIVALPROEX SODIUMREMEDYREPACK INC.cf15569c-5010-4e9b-aef0-7df4de5ed04e2026-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1099870
Divalproex SodiumDIVALPROEX SODIUMREMEDYREPACK INC.ed24bb3a-bba1-4b27-8733-96619793fc152026-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1099870
divalproex sodiumDIVALPROEX SODIUMBionpharma Inc.19064624-81d1-4ce3-bfe4-955bad6af6a22026-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1099678
rxcui: 1099870
rxcui: 1099625

Reported adverse events (FAERS/openFDA)#

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