FDA.reportPublic FDA data

Divalproex Sodium

Product NDC
57237-048
11-digit product format
572370048
Labeler code
57237
Product ID
57237-048_0e7b49f5-b6a5-4b9c-96d6-a28064b641dd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA090554
Marketing category
ANDA
Marketing start
2014-10-24
Substance
DIVALPROEX SODIUM
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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIVALPROEX SODIUM500 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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
57237-048-01Divalproex Sodium100 in 1 BOTTLETABLET, DELAYED RELEASE10023
57237-048-05Divalproex Sodium500 in 1 BOTTLETABLET, DELAYED RELEASE50023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-048-01EA - Each57237-0482521616d-fdec-403d-bd07-0f998f4d592c12014-04-03
57237-048-05EA - Each57237-04847c23fc7-ddc1-4217-b2e1-6a95ae4e889612014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIVALPROEX SODIUMACTIVE INGREDIENT644VL95AO6DIVALPROEX SODIUM TABLET, DELAYED RELEASE [CITRON PHARMA LLC]5
VALPROIC ACIDACTIVE MOIETY614OI1Z5WIDIVALPROEX SODIUM TABLET, DELAYED RELEASE [CITRON PHARMA LLC]5
AMMONIAINACTIVE INGREDIENT5138Q19F1XDIVALPROEX SODIUM TABLET, DELAYED RELEASE [CITRON PHARMA LLC]5
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3DIVALPROEX SODIUM TABLET, DELAYED RELEASE [CITRON PHARMA LLC]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIVALPROEX SODIUM TABLET, DELAYED RELEASE [CITRON PHARMA LLC]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48DIVALPROEX SODIUM TABLET, DELAYED RELEASE [CITRON PHARMA LLC]5
DIETHYL PHTHALATEINACTIVE INGREDIENTUF064M00AFDIVALPROEX SODIUM TABLET, DELAYED RELEASE [CITRON PHARMA LLC]5
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDIVALPROEX SODIUM TABLET, DELAYED RELEASE [CITRON PHARMA LLC]5
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADIVALPROEX SODIUM TABLET, DELAYED RELEASE [CITRON PHARMA LLC]5
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MDIVALPROEX SODIUM TABLET, DELAYED RELEASE [CITRON PHARMA LLC]5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DIVALPROEX SODIUM TABLET, DELAYED RELEASE [CITRON PHARMA LLC]5
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDIVALPROEX SODIUM TABLET, DELAYED RELEASE [CITRON PHARMA LLC]5
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DIVALPROEX SODIUM TABLET, DELAYED RELEASE [CITRON PHARMA LLC]5
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14DIVALPROEX SODIUM TABLET, DELAYED RELEASE [CITRON PHARMA LLC]5
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WDIVALPROEX SODIUM TABLET, DELAYED RELEASE [CITRON PHARMA LLC]5
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302DIVALPROEX SODIUM TABLET, DELAYED RELEASE [CITRON PHARMA LLC]5
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62DIVALPROEX SODIUM TABLET, DELAYED RELEASE [CITRON PHARMA LLC]5
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JDIVALPROEX SODIUM TABLET, DELAYED RELEASE [CITRON PHARMA LLC]5
METHYLENE CHLORIDEINACTIVE INGREDIENT588X2YUY0ADIVALPROEX SODIUM TABLET, DELAYED RELEASE [CITRON PHARMA LLC]5
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PDIVALPROEX SODIUM TABLET, DELAYED RELEASE [CITRON PHARMA LLC]5
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990DIVALPROEX SODIUM TABLET, DELAYED RELEASE [CITRON PHARMA LLC]5
POVIDONE K30INACTIVE INGREDIENTU725QWY32XDIVALPROEX SODIUM TABLET, DELAYED RELEASE [CITRON PHARMA LLC]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DIVALPROEX SODIUM TABLET, DELAYED RELEASE [CITRON PHARMA LLC]5
SHELLACINACTIVE INGREDIENT46N107B71ODIVALPROEX SODIUM TABLET, DELAYED RELEASE [CITRON PHARMA LLC]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIVALPROEX SODIUM TABLET, DELAYED RELEASE [CITRON PHARMA LLC]5
TALCINACTIVE INGREDIENT7SEV7J4R1UDIVALPROEX SODIUM TABLET, DELAYED RELEASE [CITRON PHARMA LLC]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDIVALPROEX SODIUM TABLET, DELAYED RELEASE [CITRON PHARMA LLC]5
TRIACETININACTIVE INGREDIENTXHX3C3X673DIVALPROEX SODIUM TABLET, DELAYED RELEASE [CITRON PHARMA LLC]5
VANILLININACTIVE INGREDIENTCHI530446XDIVALPROEX SODIUM TABLET, DELAYED RELEASE [CITRON PHARMA LLC]5
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
57237-048DIVALPROEX SODIUM TABLET, DELAYED RELEASE [RISING PHARMA HOLDINGS, INC.]21Current NDC, Legacy NDC, 2 package rows20250423_6316061c-9758-4f38-9cb2-7ca833dd20bf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099870divalproex sodium 500 MG Delayed Release Oral TabletPSNfbaff0ae-431e-4e83-81c2-41eb4b18ee87105
1099870divalproex sodium 500 MG Delayed Release Oral TabletSCDfbaff0ae-431e-4e83-81c2-41eb4b18ee87105
1099625divalproex sodium 125 MG Delayed Release Oral TabletPSN6316061c-9758-4f38-9cb2-7ca833dd20bf23
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSN6316061c-9758-4f38-9cb2-7ca833dd20bf23
1099870divalproex sodium 500 MG Delayed Release Oral TabletPSN6316061c-9758-4f38-9cb2-7ca833dd20bf23
1099625divalproex sodium 125 MG Delayed Release Oral TabletSCD6316061c-9758-4f38-9cb2-7ca833dd20bf23
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCD6316061c-9758-4f38-9cb2-7ca833dd20bf23
1099870divalproex sodium 500 MG Delayed Release Oral TabletSCD6316061c-9758-4f38-9cb2-7ca833dd20bf23
1099870divalproex sodium 500 MG Delayed Release Oral TabletPSN0339e27d-3dbf-4c37-a14e-f53557c08e1917
1099870divalproex sodium 500 MG Delayed Release Oral TabletSCD0339e27d-3dbf-4c37-a14e-f53557c08e1917
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
1099870divalproex sodium 500 MG Delayed Release Oral TabletPSNc36f34f0-f700-4178-ac85-46c2f7e1f66c6
1099870divalproex sodium 500 MG Delayed Release Oral TabletSCDc36f34f0-f700-4178-ac85-46c2f7e1f66c6
1099870divalproex sodium 500 MG Delayed Release Oral TabletPSNf3a92756-72ad-4429-9c7a-b38de0695d3d1
1099870divalproex sodium 500 MG Delayed Release Oral TabletSCDf3a92756-72ad-4429-9c7a-b38de0695d3d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
57237-048-0157237004801100 TABLET, DELAYED RELEASE in 1 BOTTLE (57237-048-01) 2014-10-240000-00-00NoNoCurrent
57237-048-0557237004805500 TABLET, DELAYED RELEASE in 1 BOTTLE (57237-048-05) 2014-10-240000-00-00NoNoCurrent