FDA.reportPublic FDA data

Divalproex Sodium

Product NDC
68084-313
11-digit product format
680840313
Labeler code
68084
Product ID
68084-313_337704d6-7d3c-1fee-e063-6394a90a664b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex Sodium
Dosage form
CAPSULE, COATED PELLETS
Route
ORAL
Labeler
American Health Packaging
Application
ANDA078919
Marketing category
ANDA
Marketing start
2009-03-18
Substance
DIVALPROEX SODIUM
Active strength
125 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Divalproex Sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIVALPROEX SODIUM125 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii644VL95AO6
Rxcui1099596

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b10a892b-b985-4cbc-9547-9ac4b72b784fProduct name220250818
7a3a03f1-382a-f9ec-0741-ff24dcbfed69Product name720250624
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
57fc3d01-4737-4091-9728-9e8a4c9e708dProduct name120200121
5d67ecc7-47c7-ec5e-e9eb-71bf00250645Product name120140508
97fce1a8-50c4-f088-0e31-64d82b6e9081Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68084-313-01Divalproex Sodium100 in 1 BOX, UNIT-DOSECAPSULE, COATED PELLETS10012
68084-313-11Divalproex Sodium1 in 1 BLISTER PACKCAPSULE, COATED PELLETS112
68084-313-65Divalproex Sodium50 in 1 CARTONCAPSULE, COATED PELLETS5012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-313-01EA - Each68084-313e2ff4939-6769-473c-b247-bbfa4b26214912012-07-24
68084-313-11EA - Each68084-3138b56ab84-b798-40f8-bcdb-b40b25e6d5b312012-07-24
68084-313-65EA - Each68084-3133023ae5c-9df2-4666-bbdc-2e7761afc82e12024-07-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIVALPROEX SODIUMACTIVE INGREDIENT644VL95AO6DIVALPROEX SODIUM CAPSULE, COATED PELLETS [CARDINAL HEALTH]6
VALPROIC ACIDACTIVE MOIETY614OI1Z5WIDIVALPROEX SODIUM CAPSULE, COATED PELLETS [CARDINAL HEALTH]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIVALPROEX SODIUM CAPSULE, COATED PELLETS [CARDINAL HEALTH]6
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDIVALPROEX SODIUM CAPSULE, COATED PELLETS [CARDINAL HEALTH]6
GELATININACTIVE INGREDIENT2G86QN327LDIVALPROEX SODIUM CAPSULE, COATED PELLETS [CARDINAL HEALTH]6
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODIVALPROEX SODIUM CAPSULE, COATED PELLETS [CARDINAL HEALTH]6
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH13DIVALPROEX SODIUM CAPSULE, COATED PELLETS [CARDINAL HEALTH]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIVALPROEX SODIUM CAPSULE, COATED PELLETS [CARDINAL HEALTH]6
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDIVALPROEX SODIUM CAPSULE, COATED PELLETS [CARDINAL HEALTH]6
TALCINACTIVE INGREDIENT7SEV7J4R1UDIVALPROEX SODIUM CAPSULE, COATED PELLETS [CARDINAL HEALTH]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDIVALPROEX SODIUM CAPSULE, COATED PELLETS [CARDINAL HEALTH]6
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMDIVALPROEX SODIUM CAPSULE, COATED PELLETS [CARDINAL HEALTH]6
DIVALPROEX SODIUMACTIVE INGREDIENT644VL95AO6DIVALPROEX SODIUM CAPSULE, COATED PELLETS [AMERICAN HEALTH PACKAGING]3
VALPROIC ACIDACTIVE MOIETY614OI1Z5WIDIVALPROEX SODIUM CAPSULE, COATED PELLETS [AMERICAN HEALTH PACKAGING]3
ALCOHOLINACTIVE INGREDIENT3K9958V90MDIVALPROEX SODIUM CAPSULE, COATED PELLETS [AMERICAN HEALTH PACKAGING]3
AMMONIAINACTIVE INGREDIENT5138Q19F1XDIVALPROEX SODIUM CAPSULE, COATED PELLETS [AMERICAN HEALTH PACKAGING]3
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3DIVALPROEX SODIUM CAPSULE, COATED PELLETS [AMERICAN HEALTH PACKAGING]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIVALPROEX SODIUM CAPSULE, COATED PELLETS [AMERICAN HEALTH PACKAGING]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDIVALPROEX SODIUM CAPSULE, COATED PELLETS [AMERICAN HEALTH PACKAGING]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DIVALPROEX SODIUM CAPSULE, COATED PELLETS [AMERICAN HEALTH PACKAGING]3
GELATININACTIVE INGREDIENT2G86QN327LDIVALPROEX SODIUM CAPSULE, COATED PELLETS [AMERICAN HEALTH PACKAGING]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODIVALPROEX SODIUM CAPSULE, COATED PELLETS [AMERICAN HEALTH PACKAGING]3
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302DIVALPROEX SODIUM CAPSULE, COATED PELLETS [AMERICAN HEALTH PACKAGING]3
METHACRYLIC ACIDINACTIVE INGREDIENT1CS02G8656DIVALPROEX SODIUM CAPSULE, COATED PELLETS [AMERICAN HEALTH PACKAGING]3
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TDIVALPROEX SODIUM CAPSULE, COATED PELLETS [AMERICAN HEALTH PACKAGING]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DIVALPROEX SODIUM CAPSULE, COATED PELLETS [AMERICAN HEALTH PACKAGING]3
SHELLACINACTIVE INGREDIENT46N107B71ODIVALPROEX SODIUM CAPSULE, COATED PELLETS [AMERICAN HEALTH PACKAGING]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIVALPROEX SODIUM CAPSULE, COATED PELLETS [AMERICAN HEALTH PACKAGING]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDIVALPROEX SODIUM CAPSULE, COATED PELLETS [AMERICAN HEALTH PACKAGING]3
TALCINACTIVE INGREDIENT7SEV7J4R1UDIVALPROEX SODIUM CAPSULE, COATED PELLETS [AMERICAN HEALTH PACKAGING]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDIVALPROEX SODIUM CAPSULE, COATED PELLETS [AMERICAN HEALTH PACKAGING]3
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMDIVALPROEX SODIUM CAPSULE, COATED PELLETS [AMERICAN HEALTH PACKAGING]3
WATERINACTIVE INGREDIENT059QF0KO0RDIVALPROEX SODIUM CAPSULE, COATED PELLETS [AMERICAN HEALTH PACKAGING]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-313DIVALPROEX SODIUM CAPSULE, COATED PELLETS [AMERICAN HEALTH PACKAGING]12Current NDC, Legacy NDC, 3 package rows20250425_2e4778d8-8798-4da1-bb33-1aa1414b5809.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099596divalproex sodium 125 MG Delayed Release Oral CapsulePSN8e86a610-45ef-4be7-a3ab-f656f5b3270615
1099596divalproex sodium 125 MG Delayed Release Oral CapsuleSCD8e86a610-45ef-4be7-a3ab-f656f5b3270615
1099596divalproex sodium 125 MG Delayed Release Oral CapsulePSN2e4778d8-8798-4da1-bb33-1aa1414b580912
1099596divalproex sodium 125 MG Delayed Release Oral CapsuleSCD2e4778d8-8798-4da1-bb33-1aa1414b580912

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68084-313-0168084031301100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-313-01) / 1 CAPSULE, COATED PELLETS in 1 BLISTER PACK (68084-313-11) 100 blister pack2009-03-180000-00-00NoNoCurrent
68084-313-11680840313111 in 1 BLISTER PACKHistorical
68084-313-656808403136550 BLISTER PACK in 1 CARTON (68084-313-65) / 1 CAPSULE, COATED PELLETS in 1 BLISTER PACK (68084-313-11) 50 blister pack2024-06-26NoNoCurrent