FDA.reportPublic FDA data

Divalproex Sodium

Product NDC
65862-959
11-digit product format
658620959
Labeler code
65862
Product ID
65862-959_3b5e2f9c-96b3-4b68-b0bb-91b0f4ef344b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA090554
Marketing category
ANDA
Marketing start
2014-10-24
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
Rxcui1099625, 1099678, 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
65862-959-01Divalproex Sodium100 in 1 BOTTLETABLET, DELAYED RELEASE10035
65862-959-05Divalproex Sodium500 in 1 BOTTLETABLET, DELAYED RELEASE50035
65862-959-10Divalproex Sodium10 in 1 BLISTER PACKTABLET, DELAYED RELEASE1035
65862-959-10Divalproex Sodium10 in 1 CARTONTABLET, DELAYED RELEASE1035
65862-959-71Divalproex Sodium7000 in 1 BOTTLETABLET, DELAYED RELEASE700035
65862-959-99Divalproex Sodium1000 in 1 BOTTLETABLET, DELAYED RELEASE100035

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIVALPROEX SODIUMACTIVE INGREDIENT644VL95AO6DIVALPROEX SODIUM TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]16
VALPROIC ACIDACTIVE MOIETY614OI1Z5WIDIVALPROEX SODIUM TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]16
AMMONIAINACTIVE INGREDIENT5138Q19F1XDIVALPROEX SODIUM TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]16
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3DIVALPROEX SODIUM TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]16
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIVALPROEX SODIUM TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]16
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48DIVALPROEX SODIUM TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]16
DIETHYL PHTHALATEINACTIVE INGREDIENTUF064M00AFDIVALPROEX SODIUM TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]16
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDIVALPROEX SODIUM TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]16
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADIVALPROEX SODIUM TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]16
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DIVALPROEX SODIUM TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]16
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDIVALPROEX SODIUM TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]16
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DIVALPROEX SODIUM TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]16
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14DIVALPROEX SODIUM TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]16
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WDIVALPROEX SODIUM TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]16
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302DIVALPROEX SODIUM TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]16
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62DIVALPROEX SODIUM TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]16
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JDIVALPROEX SODIUM TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]16
METHYLENE CHLORIDEINACTIVE INGREDIENT588X2YUY0ADIVALPROEX SODIUM TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]16
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PDIVALPROEX SODIUM TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]16
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990DIVALPROEX SODIUM TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]16
POVIDONE K30INACTIVE INGREDIENTU725QWY32XDIVALPROEX SODIUM TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]16
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DIVALPROEX SODIUM TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]16
SHELLACINACTIVE INGREDIENT46N107B71ODIVALPROEX SODIUM TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]16
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIVALPROEX SODIUM TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]16
TALCINACTIVE INGREDIENT7SEV7J4R1UDIVALPROEX SODIUM TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]16
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDIVALPROEX SODIUM TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]16
TRIACETININACTIVE INGREDIENTXHX3C3X673DIVALPROEX SODIUM TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]16
VANILLININACTIVE INGREDIENTCHI530446XDIVALPROEX SODIUM TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-959DIVALPROEX SODIUM TABLET, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]33Current NDC, Legacy NDC, 6 package rows20250317_dbd47222-14f1-4588-a009-9b81b55ca60d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099625divalproex sodium 125 MG Delayed Release Oral TabletPSNdbd47222-14f1-4588-a009-9b81b55ca60d35
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSNdbd47222-14f1-4588-a009-9b81b55ca60d35
1099870divalproex sodium 500 MG Delayed Release Oral TabletPSNdbd47222-14f1-4588-a009-9b81b55ca60d35
1099625divalproex sodium 125 MG Delayed Release Oral TabletSCDdbd47222-14f1-4588-a009-9b81b55ca60d35
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCDdbd47222-14f1-4588-a009-9b81b55ca60d35
1099870divalproex sodium 500 MG Delayed Release Oral TabletSCDdbd47222-14f1-4588-a009-9b81b55ca60d35

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-959-0165862095901100 TABLET, DELAYED RELEASE in 1 BOTTLE (65862-959-01) 2014-10-240000-00-00NoNoCurrent
65862-959-0565862095905500 TABLET, DELAYED RELEASE in 1 BOTTLE (65862-959-05) 2014-10-240000-00-00NoNoCurrent
65862-959-106586209591010 BLISTER PACK in 1 CARTON (65862-959-10) / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK10 blister pack2014-10-240000-00-00NoNoCurrent
65862-959-71658620959717000 TABLET, DELAYED RELEASE in 1 BOTTLE (65862-959-71) 2014-10-240000-00-00NoNoCurrent
65862-959-99658620959991000 TABLET, DELAYED RELEASE in 1 BOTTLE (65862-959-99) 2014-10-240000-00-00NoNoCurrent