FDA.reportPublic FDA data

divalproex sodium

Product NDC
68382-106
11-digit product format
683820106
Labeler code
68382
Product ID
68382-106_3b089c0e-35d2-40ed-a4ad-7c9c32c391be
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
divalproex sodium
Dosage form
CAPSULE, COATED PELLETS
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA078919
Marketing category
ANDA
Marketing start
2009-01-27
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
divalproex sodium
Listing expiration
2027-12-31

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
68382-106-01divalproex sodium100 in 1 BOTTLECAPSULE, COATED PELLETS10032
68382-106-10divalproex sodium1000 in 1 BOTTLECAPSULE, COATED PELLETS100032
68382-106-30divalproex sodium1 in 1 BLISTER PACKCAPSULE, COATED PELLETS132
68382-106-77divalproex sodium100 in 1 CARTONCAPSULE, COATED PELLETS10032

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-106-01EA - Each68382-106577f5278-da81-46e2-a62f-55fc9b1715c412012-07-24
68382-106-10EA - Each68382-10646425afc-2d35-4347-a969-20bc96184ab112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIVALPROEX SODIUMACTIVE INGREDIENT644VL95AO6DIVALPROEX SODIUM CAPSULE, COATED PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]12
VALPROIC ACIDACTIVE MOIETY614OI1Z5WIDIVALPROEX SODIUM CAPSULE, COATED PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]12
ALCOHOLINACTIVE INGREDIENT3K9958V90MDIVALPROEX SODIUM CAPSULE, COATED PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]12
AMMONIAINACTIVE INGREDIENT5138Q19F1XDIVALPROEX SODIUM CAPSULE, COATED PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]12
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3DIVALPROEX SODIUM CAPSULE, COATED PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]12
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIVALPROEX SODIUM CAPSULE, COATED PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]12
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDIVALPROEX SODIUM CAPSULE, COATED PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]12
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DIVALPROEX SODIUM CAPSULE, COATED PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]12
GELATININACTIVE INGREDIENT2G86QN327LDIVALPROEX SODIUM CAPSULE, COATED PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]12
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODIVALPROEX SODIUM CAPSULE, COATED PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]12
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302DIVALPROEX SODIUM CAPSULE, COATED PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]12
METHACRYLIC ACIDINACTIVE INGREDIENT1CS02G8656DIVALPROEX SODIUM CAPSULE, COATED PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]12
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TDIVALPROEX SODIUM CAPSULE, COATED PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]12
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DIVALPROEX SODIUM CAPSULE, COATED PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]12
SHELLACINACTIVE INGREDIENT46N107B71ODIVALPROEX SODIUM CAPSULE, COATED PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]12
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIVALPROEX SODIUM CAPSULE, COATED PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]12
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDIVALPROEX SODIUM CAPSULE, COATED PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]12
TALCINACTIVE INGREDIENT7SEV7J4R1UDIVALPROEX SODIUM CAPSULE, COATED PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]12
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDIVALPROEX SODIUM CAPSULE, COATED PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]12
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMDIVALPROEX SODIUM CAPSULE, COATED PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]12
WATERINACTIVE INGREDIENT059QF0KO0RDIVALPROEX SODIUM CAPSULE, COATED PELLETS [ZYDUS PHARMACEUTICALS (USA) INC.]12
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
68382-106DIVALPROEX SODIUM CAPSULE, COATED PELLETS [ZYDUS PHARMACEUTICALS USA INC.]31Current NDC, Legacy NDC, 4 package rows20250523_ed710c62-8ba6-4f19-b240-3ee73cd03d67.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099596divalproex sodium 125 MG Delayed Release Oral CapsulePSNed710c62-8ba6-4f19-b240-3ee73cd03d6732
1099596divalproex sodium 125 MG Delayed Release Oral CapsuleSCDed710c62-8ba6-4f19-b240-3ee73cd03d6732
1099596divalproex sodium 125 MG Delayed Release Oral CapsulePSNab8616a5-ea72-4df7-b095-54ea19ef6fba16
1099596divalproex sodium 125 MG Delayed Release Oral CapsuleSCDab8616a5-ea72-4df7-b095-54ea19ef6fba16
1099596divalproex sodium 125 MG Delayed Release Oral CapsulePSN2e4778d8-8798-4da1-bb33-1aa1414b580912
1099596divalproex sodium 125 MG Delayed Release Oral CapsuleSCD2e4778d8-8798-4da1-bb33-1aa1414b580912
1099596divalproex sodium 125 MG Delayed Release Oral CapsulePSN699a9722-27bd-4e90-819b-d4ecb99466c84
1099596divalproex sodium 125 MG Delayed Release Oral CapsuleSCD699a9722-27bd-4e90-819b-d4ecb99466c84

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-106-0168382010601100 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-106-01) 2009-01-270000-00-00NoNoCurrent
68382-106-10683820106101000 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-106-10) 2009-01-270000-00-00NoNoCurrent
68382-106-30683820106301 in 1 BLISTER PACKHistorical
68382-106-7768382010677100 BLISTER PACK in 1 CARTON (68382-106-77) / 1 CAPSULE, COATED PELLETS in 1 BLISTER PACK (68382-106-30) 100 blister pack2009-01-270000-00-00NoNoCurrent