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 43 of 174 · 3,479 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acne Drops 2001ACNE DROPSProfessional Complementary Health Formulas340fc7dc-2aa4-411f-842b-4ce7046717222026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Travel Immunization Detox 6033TRAVEL IMMUNIZATION DETOXProfessional Complementary Health Formulasb74abfad-fe22-476c-9692-07d66cc15ac52026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Thymus Drops 5027THYMUS DROPSProfessional Complementary Health Formulas8d7c42f7-02ae-4992-986f-4743151ad3bb2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Amalgam 6003AMALGAMProfessional Complementary Health Formulas1af74f69-a23a-45a2-a20e-92bf8b0ccb222026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
unii: TTV12P4NEE
Rose Quartz 8142ROSE QUARTZProfessional Complementary Health Formulas898cd57d-8656-457d-92ff-5b4ea13578002026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Pneumo Drops 5018PNEUMO DROPSProfessional Complementary Health Formulasea6d0286-db1c-48c0-83fd-c18fa8f8629f2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Difficulty Breathing Drops 2171DIFFICULTY BREATHING DROPSProfessional Complementary Health Formulas30bab475-47dd-4261-b497-1f8edf9dd4112026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
RET Spleen/Pancreas 7002RET SPLEEN/PANCREASProfessional Complementary Health Formulasc6c82d50-0650-4cd9-85b9-c3cd422a35ce2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Vaccinosis Nosode 4004VACCINOSIS NOSODEProfessional Complementary Health Formulasdff675b3-6330-45d0-984c-526a8f44202b2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Sinusitis Drops 2060SINUSITIS DROPSProfessional Complementary Health Formulas00469764-e0ab-45cf-8e61-6bdc67d31e542026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Large Ring Combination 9302LARGE RING COMBINATIONProfessional Complementary Health Formulascced8a69-7bc0-42ad-b80a-58fc603bf7652026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Enviro Detox 6009ENVIRO DETOXProfessional Complementary Health Formulasa6aab63a-9313-4490-b3a4-0b08f7753cc52026-01-08WarningsExact identifier
unii: 5138Q19F1X
Domestic Animals Nosode Combination 9407DOMESTIC ANIMALS NOSODE COMBINATIONProfessional Complementary Health Formulas222c28aa-e07b-4706-9fb5-585b190f1c5b2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
BADABOOM SUNSCREENSUNSCREENAopline Biotechnology (Guangzhou) Co., Ltd.47dbf363-2892-4530-e063-6294a90abe1f2026-01-08WarningsExact identifier
unii: 15FIX9V2JP
ROE WELLNESS SPF 50 MINERALSPF 50 MINERAL POWDERAopline Biotechnology (Guangzhou) Co., Ltd.47dc8155-4abb-4bb7-e063-6294a90af1ad2026-01-08WarningsExact identifier
unii: 15FIX9V2JP
ALOHA MINERAL BLOCK-BRUSH ON MINERALSUNSCREEN SPF50Aopline Biotechnology (Guangzhou) Co., Ltd.47dd07aa-71b4-5d54-e063-6394a90a41272026-01-08WarningsExact identifier
unii: 15FIX9V2JP
Thompson AlcoholISOPROPYL ALCOHOLThompsonf539db3b-f309-6a60-e053-2a95a90a5a9b2026-01-08WarningsExact identifier
unii: ND2M416302
Lubricant Eye Drops SolutionPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAvPAKf5743b38-e3d2-a065-e053-2995a90a4b9a2026-01-08WarningsExact identifier
unii: 6DC9Q167V3
divalproex sodiumDIVALPROEX SODIUMAmerican Health Packagingb12b76a0-4b6e-4cd4-9508-10a2c84d8beb2026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1099569
rxcui: 1099563
unii: 644VL95AO6
Divalproex SodiumDIVALPROEX SODIUMAvPAKe8cc336b-5191-7f8b-e053-2a95a90a6acb2026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1099569
rxcui: 1099563
unii: 644VL95AO6

Reported adverse events (FAERS/openFDA)#

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