FDA.reportPublic FDA data

Divalproex Sodium

Product NDC
68084-782
11-digit product format
680840782
Labeler code
68084
Product ID
68084-782_2e987eda-590b-fcc5-e063-6294a90aeb0d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA090554
Marketing category
ANDA
Marketing start
2016-01-26
Substance
DIVALPROEX SODIUM
Active strength
500 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 SODIUM500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii644VL95AO6
Rxcui1099678, 1099870

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b10a892b-b985-4cbc-9547-9ac4b72b784fProduct name220250818
7a3a03f1-382a-f9ec-0741-ff24dcbfed69Product name720250624
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
57fc3d01-4737-4091-9728-9e8a4c9e708dProduct name120200121
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5d67ecc7-47c7-ec5e-e9eb-71bf00250645Product name120140508
97fce1a8-50c4-f088-0e31-64d82b6e9081Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68084-782-11Divalproex Sodium1 in 1 BLISTER PACKTABLET, DELAYED RELEASE114
68084-782-61Divalproex Sodium90 in 1 BOX, UNIT-DOSETABLET, DELAYED RELEASE9014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-782-01EA - Each68084-782222c89ed-41ee-4427-8b3b-bbb1db1518e912015-05-05
68084-782-11EA - Each68084-782e96f8635-fb64-4533-87bb-5610bd858ad212015-05-05
68084-782-32EA - Each68084-78257afcb6f-5bb4-4955-a820-cef2ddc064a812014-12-01
68084-782-33EA - Each68084-78211e83f3b-0a17-4a3c-b039-3f2dab2013ff12014-12-01
68084-782-61EA - Each68084-782726ae131-9af4-421d-9df8-15b5d4826a5a12016-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIVALPROEX SODIUMACTIVE INGREDIENT644VL95AO6DIVALPROEX SODIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]4
VALPROIC ACIDACTIVE MOIETY614OI1Z5WIDIVALPROEX SODIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]4
AMMONIAINACTIVE INGREDIENT5138Q19F1XDIVALPROEX SODIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]4
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3DIVALPROEX SODIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIVALPROEX SODIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48DIVALPROEX SODIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]4
DIETHYL PHTHALATEINACTIVE INGREDIENTUF064M00AFDIVALPROEX SODIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]4
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDIVALPROEX SODIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADIVALPROEX SODIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DIVALPROEX SODIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDIVALPROEX SODIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DIVALPROEX SODIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]4
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14DIVALPROEX SODIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODIVALPROEX SODIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]4
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302DIVALPROEX SODIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]4
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62DIVALPROEX SODIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]4
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JDIVALPROEX SODIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]4
METHYLENE CHLORIDEINACTIVE INGREDIENT588X2YUY0ADIVALPROEX SODIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]4
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PDIVALPROEX SODIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]4
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990DIVALPROEX SODIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]4
POVIDONE K30INACTIVE INGREDIENTU725QWY32XDIVALPROEX SODIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DIVALPROEX SODIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]4
SHELLACINACTIVE INGREDIENT46N107B71ODIVALPROEX SODIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIVALPROEX SODIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]4
TALCINACTIVE INGREDIENT7SEV7J4R1UDIVALPROEX SODIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDIVALPROEX SODIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]4
TRIACETININACTIVE INGREDIENTXHX3C3X673DIVALPROEX SODIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]4
VANILLININACTIVE INGREDIENTCHI530446XDIVALPROEX SODIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-782DIVALPROEX SODIUM TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]14Current NDC, Legacy NDC, 2 package rows20250224_64b509bc-f398-48ad-bdcb-9904e61d9225.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSN64b509bc-f398-48ad-bdcb-9904e61d922514
1099870divalproex sodium 500 MG Delayed Release Oral TabletPSN64b509bc-f398-48ad-bdcb-9904e61d922514
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCD64b509bc-f398-48ad-bdcb-9904e61d922514
1099870divalproex sodium 500 MG Delayed Release Oral TabletSCD64b509bc-f398-48ad-bdcb-9904e61d922514
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSNee2e8924-2379-400d-9895-e3aa02fe64269
1099870divalproex sodium 500 MG Delayed Release Oral TabletPSNee2e8924-2379-400d-9895-e3aa02fe64269
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCDee2e8924-2379-400d-9895-e3aa02fe64269
1099870divalproex sodium 500 MG Delayed Release Oral TabletSCDee2e8924-2379-400d-9895-e3aa02fe64269

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68084-782-11680840782111 in 1 BLISTER PACKHistorical
68084-782-616808407826190 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-782-61) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (68084-782-11) 90 blister pack2016-01-262026-06-30NoNoCurrent