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 56 of 174 · 3,468 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
YOUR SKIN BUT BETTER CC COLOR CORRECTING FULL COVERAGE SPF 50 TANTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLC5cce7646-d9f5-454b-b7a8-a5a6b62a19162025-12-19WarningsExact identifier
unii: 15FIX9V2JP
YOUR SKIN BUT BETTER CC COLOR CORRECTING FULL COVERAGE SPF 50 RICHTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLC7da16dd7-c26c-4c4e-905f-3bbb878022cc2025-12-19WarningsExact identifier
unii: 15FIX9V2JP
YOUR SKIN BUT BETTER CC COLOR CORRECTING FULL COVERAGE SPF 50 MEDIUM-TANTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLC85f3dd47-4f1f-4fa3-a171-4f4b7707191c2025-12-19WarningsExact identifier
unii: 15FIX9V2JP
YOUR SKIN BUT BETTER CC ILLUMINATION FAIRTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLC4e5764f3-9d9e-460b-ab1e-36f280281dec2025-12-19WarningsExact identifier
unii: 15FIX9V2JP
YOUR SKIN BUT BETTER CC COLOR CORRECTING FULL COVERAGE SPF 50 MEDIUMTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLCe700dc6e-e7ae-47ee-9974-430bfd045b4f2025-12-19WarningsExact identifier
unii: 15FIX9V2JP
YOUR SKIN BUT BETTER CC ILLUMINATION MEDIUM-TANTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLCc7924d60-03fb-4a4d-b718-e324f6f1f65f2025-12-19WarningsExact identifier
unii: 15FIX9V2JP
THE MINERAL MELT Invisible Mineral Suncare for FaceTITANIUM DIOXIDE, ZINC OXIDEDune Suncare, Inc.46557319-7546-e712-e063-6394a90a3cfe2025-12-19WarningsExact identifier
unii: 15FIX9V2JP
Sand Cloud Mineral SunscreenTITANIUM DIOXIDE AND ZINC OXIDESand Cloud Holdings, LLCff477199-9b01-fc90-e053-6294a90a51022025-12-19WarningsExact identifier
unii: 15FIX9V2JP
Sand Cloud Mineral Sunscreen For FaceTITANIUM DIOXIDE AND ZINC OXIDESand Cloud Holdings, LLCff2346c6-d911-87b3-e053-6394a90ac6f82025-12-19WarningsExact identifier
unii: 15FIX9V2JP
Walgreens LubricantPOLYETHYLENE GLYCOL 400, AND PROPYLENE GLYCOLWalgreens21dfe061-4538-2061-e063-6394a90a6e732025-12-19WarningsExact identifier
unii: 6DC9Q167V3
Artificial TearsGLYCERINGeri-Care Pharmaceuticals, Corp7cc437e3-bad9-59be-e053-2991aa0a1da32025-12-19WarningsExact identifier
unii: 3NXW29V3WO
Radiant Defense Perfecting Liquid Broad Spectrum SPF 30 - ShellTITANIUM DIOXIDE, ZINC OXIDERodan & Fields12c63195-8707-4df0-a4d3-6f31c543db7a2025-12-19WarningsExact identifier
unii: 15FIX9V2JP
Divalproex sodiumDIVALPROEX SODIUMBryant Ranch Prepack0669ac77-10df-48af-bc42-55e768b69e4f2025-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1099569
unii: 644VL95AO6
SominezeHUMULUS LUPULUS, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, COFFEA TOSTA, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, SILICEABioActive Nutritional, Inc.c0f80b84-0dd5-416b-abdf-8a0412e0b40b2025-12-18WarningsExact identifier
unii: ETJ7Z6XBU4
SUNSCREEN SPRAY150mLZINC OXIDE 12%, TITANIUM DIOXIDE 6%, HOMOSALATE 14%, OCTISALATE 5%Foshan Sugar Max Cosmetics CO.,Ltd4635f90a-bbc9-0676-e063-6394a90a9f352025-12-18WarningsExact identifier
unii: 15FIX9V2JP
NARS PURE RADIANT TINTED MOISTURIZER CuzcoOCTINOXATE, TITANIUM DIOXIDENARS Cosmetics5bb5d035-16d9-4843-b9aa-d30730c885082025-12-18WarningsExact identifier
unii: 15FIX9V2JP
GM Collin SPF 25 UVA - UVB Urban Protection Veil SunscreenZINC OXIDE AND TITANIUM DIOXIDELaboratoires Dermo-Cosmetik Inc.4f0d44ca-09f0-4feb-b78c-77d83e75d4e22025-12-18WarningsExact identifier
unii: 15FIX9V2JP
Divalproex SodiumDIVALPROEX SODIUMAmerican Health Packaginga8ba3986-1ded-44a8-8d10-d0f252a077942025-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078239
ndc (package): 68084-310-11
ndc (package): 68084-415-11
ndc (package): 68084-310-01
ndc (package): 68084-415-02
ndc (package): 68084-415-01
ndc (package): 68084-415-93
ndc (product): 68084-310
ndc (product): 68084-415
ndc11 (package): 68084041593
rxcui: 1099569
rxcui: 1099563
spl id: 46405f96-5e81-a0c9-e063-6394a90a9592
spl set id: a8ba3986-1ded-44a8-8d10-d0f252a07794
unii: 644VL95AO6
Bye Bye Foundation Full Coverage Moisturizer SPF 50 FairTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLCb098aba3-dad6-4421-a943-e88ce5e2f8d62025-12-18WarningsExact identifier
unii: 15FIX9V2JP
it cosmetics Your Skin But Better CC Plus Color Correcting Broad Spectrum SPF 50 Plus Sunscreen Full Coverage Fair Ivory Fair Warm Fair Beige Medium Tan Warm Tan Rich Neutral Rich Neutral Deep Deep Bronze Deep Honey Deep MochaTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLCb3260833-8b7c-4d88-a55a-8cef4938442d2025-12-18WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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