FDA.reportPublic FDA data

NDC 68084-415-93 - 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
68084-415
Requested NDC
68084-415-93
Package NDCs from labels
68084-415-11, 68084-415-01, 68084-415-93, 68084-415-02
Manufacturer
American Health Packaging
Effective date
2025-12-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Divalproex Sodium - American Health PackagingAmerican Health Packaging2025-12-18HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68084-415-01Divalproex Sodium100 in 1 BOX, UNIT-DOSETABLET, FILM COATED, EXTENDED RE10015
68084-415-02Divalproex Sodium80 in 1 CARTONTABLET, FILM COATED, EXTENDED RE8015
68084-415-11Divalproex Sodium1 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE115
68084-415-93Divalproex Sodium1 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE115

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-415DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]12Current NDC, Legacy NDC, 4 package rows20250302_a8ba3986-1ded-44a8-8d10-d0f252a07794.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-415-01EA - Each68084-415dfff38ef-4111-4b01-853e-51013b75723712013-12-02
68084-415-02EA - Each68084-4154bb595ff-83cc-4664-a0e9-cd9a9ad073b912023-03-13
68084-415-11EA - Each68084-415d53b20a1-3640-42e4-8d97-9e319643ee0012013-12-02
68084-415-93EA - Each68084-41585f6dd7c-fccd-4fcf-a59f-8d74a56829c612023-03-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIVALPROEX SODIUMACTIVE INGREDIENT644VL95AO6DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]3
VALPROIC ACIDACTIVE MOIETY614OI1Z5WIDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]3
AMMONIAINACTIVE INGREDIENT5138Q19F1XDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]3
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]3
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]3
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]3
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]3
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]3
SHELLACINACTIVE INGREDIENT46N107B71ODIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]3
TALCINACTIVE INGREDIENT7SEV7J4R1UDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]3
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]3

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 19 of 175 · 3,496 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
divalproex sodiumDIVALPROEX SODIUMFirst Nation Group, LLCa76f9909-28c9-4eb7-8ffd-ff6222fea0792026-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 644VL95AO6
Anything SPFOCTINOXATE, OCTISALATE, ZINC OXIDE, AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDEAnything SPF LLC508b8dcb-6600-6dad-e063-6294a90a565a2026-04-28WarningsExact identifier
unii: 15FIX9V2JP
Divalproex SodiumDIVALPROEX SODIUMCardinal Health 107, LLC283af6d2-8ea2-4225-b2e7-a2057dbdb7932026-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1099569
unii: 644VL95AO6
3M DuraPrep SurgicalIODINE POVACRYLEX AND ISOPROPYL ALCOHOLSolventum US LLC22a10a54-6a04-48b3-9ec4-b26526183daf2026-04-23WarningsExact identifier
unii: ND2M416302
3M SoluPrep SCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLSolventum US LLC084aa305-5863-441a-a94d-36bc1b05195a2026-04-23WarningsExact identifier
unii: ND2M416302
Johnsons Baby Mineral Sunscreen SPF 30TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLC4fe04c4b-2751-0561-e063-6394a90af7682026-04-22WarningsExact identifier
unii: 15FIX9V2JP
Lazy Face SPF 30 FacescreenTITANIUM DIOXIDE, ZINC OXIDESunny Day Creations500ee303-7302-68d5-e063-6394a90ac6d42026-04-22WarningsExact identifier
unii: 15FIX9V2JP
Divalproex SodiumDIVALPROEX SODIUMSun Pharmaceutical Industries, Inc.64797788-fdcb-4d12-a1a4-743ad71bd17b2026-04-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 644VL95AO6
Divalproex SodiumDIVALPROEX SODIUMUnichem Pharmaceuticals (USA), Inc.1ec1a441-218a-4c80-a0cb-69bcc327f4722026-04-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 644VL95AO6
Divalproex SodiumDIVALPROEX SODIUMPreferred Pharmaceuticals Inc.dc9e4871-fb3d-4c59-81e5-2ab6e8be9b7c2026-04-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1099569
unii: 644VL95AO6
ELROEL Pang Pang Sun Cushion S7ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEMONOGLOT HOLDINGS Inc.256bf56f-aefa-47ce-890c-5a3896c11b922026-04-17WarningsExact identifier
unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion FairTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.3a43c7c0-7468-4b7a-95b9-f03e37f1b49b2026-04-17WarningsExact identifier
unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion Fair LightTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.a251eb20-02e6-4b55-b969-c1bef2f9d7322026-04-17WarningsExact identifier
unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion Fair PinkTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.6684d69a-89ff-41e8-81f0-3e2367811a182026-04-17WarningsExact identifier
unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion LightTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.bf24d081-85f7-4a26-9416-ecff1fe59dec2026-04-17WarningsExact identifier
unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion Pink LightTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.4a09a01a-404f-4b67-91e0-666153f550e82026-04-17WarningsExact identifier
unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion N-LightTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.cf7c4445-0382-47ab-aba9-b40d63e4f1cc2026-04-17WarningsExact identifier
unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion MediumTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.80c60ffa-69e0-4b31-bd0d-fc8ff9936ba02026-04-17WarningsExact identifier
unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion Medium DeepTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.0e18d601-700a-4c1c-a434-22582253bd952026-04-17WarningsExact identifier
unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion BronzeTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEJungsaemmool Beauty Co., Ltd.ddb3aa5e-cd1a-4792-b1b1-3604b368e0102026-04-17WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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