FDA.reportPublic FDA data

Divalproex sodium

Product NDC
65862-594
11-digit product format
658620594
Labeler code
65862
Product ID
65862-594_73af0685-290a-4d1d-9c6e-741b664cca3a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex sodium
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA202419
Marketing category
ANDA
Marketing start
2014-06-02
Substance
DIVALPROEX SODIUM
Active strength
250 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 SODIUM250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii644VL95AO6
Rxcui1099563, 1099569

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b10a892b-b985-4cbc-9547-9ac4b72b784fProduct name220250818
7a3a03f1-382a-f9ec-0741-ff24dcbfed69Product name720250624
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
65862-594-01Divalproex sodium100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE10029
65862-594-05Divalproex sodium500 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE50029
65862-594-10Divalproex sodium10 in 1 CARTONTABLET, FILM COATED, EXTENDED RE1029
65862-594-10Divalproex sodium10 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE1029
65862-594-60Divalproex sodium60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE6029
65862-594-99Divalproex sodium1000 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE100029

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-594-01EA - Each65862-594a2e2b46f-3bfe-4a40-9e12-2e1bc47d695e12014-07-02
65862-594-99EA - Each65862-594337bdc0c-238f-4d44-bfc5-790aa893479512014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIVALPROEX SODIUMACTIVE INGREDIENT644VL95AO6DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]7
VALPROIC ACIDACTIVE MOIETY614OI1Z5WIDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]7
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]7
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]7
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]7
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]7
HYPROMELLOSE 2208 (100 MPA.S)INACTIVE INGREDIENTB1QE5P712KDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]7
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]7
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]7
MANNITOLINACTIVE INGREDIENT3OWL53L36ADIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]7
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]7
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]7
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]7
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]7
SHELLACINACTIVE INGREDIENT46N107B71ODIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]7
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]7
TRIACETININACTIVE INGREDIENTXHX3C3X673DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-594DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]27Current NDC, Legacy NDC, 6 package rows20250308_6240cee7-6aa8-425c-ba46-f889a640f0fa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099563divalproex sodium 250 MG 24HR Extended Release Oral TabletPSN8b3cb30a-8d81-4aa9-bdb4-19413ae5fedf100
109956324 HR divalproex sodium 250 MG Extended Release Oral TabletSCD8b3cb30a-8d81-4aa9-bdb4-19413ae5fedf100
1099563divalproex sodium 250 MG 24 HR Extended Release Oral TabletSY8b3cb30a-8d81-4aa9-bdb4-19413ae5fedf100
1099563divalproex sodium 250 MG 24HR Extended Release Oral TabletPSN6240cee7-6aa8-425c-ba46-f889a640f0fa29
1099569divalproex sodium 500 MG 24HR Extended Release Oral TabletPSN6240cee7-6aa8-425c-ba46-f889a640f0fa29
109956324 HR divalproex sodium 250 MG Extended Release Oral TabletSCD6240cee7-6aa8-425c-ba46-f889a640f0fa29
109956924 HR divalproex sodium 500 MG Extended Release Oral TabletSCD6240cee7-6aa8-425c-ba46-f889a640f0fa29
1099563divalproex sodium 250 MG 24 HR Extended Release Oral TabletSY6240cee7-6aa8-425c-ba46-f889a640f0fa29
1099569divalproex sodium 500 MG 24 HR Extended Release Oral TabletSY6240cee7-6aa8-425c-ba46-f889a640f0fa29
1099563divalproex sodium 250 MG 24HR Extended Release Oral TabletPSN7e96b724-5f5f-43cb-8d8b-adff3e1fc77918
109956324 HR divalproex sodium 250 MG Extended Release Oral TabletSCD7e96b724-5f5f-43cb-8d8b-adff3e1fc77918
1099563divalproex sodium 250 MG 24 HR Extended Release Oral TabletSY7e96b724-5f5f-43cb-8d8b-adff3e1fc77918
1099563divalproex sodium 250 MG 24HR Extended Release Oral TabletPSNad5e8bd8-c923-40f0-a106-55620c4247d71
109956324 HR divalproex sodium 250 MG Extended Release Oral TabletSCDad5e8bd8-c923-40f0-a106-55620c4247d71
1099563divalproex sodium 250 MG 24 HR Extended Release Oral TabletSYad5e8bd8-c923-40f0-a106-55620c4247d71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-594-0165862059401100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-594-01) 2014-06-020000-00-00NoNoCurrent
65862-594-0565862059405500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-594-05) 2014-06-020000-00-00NoNoCurrent
65862-594-106586205941010 BLISTER PACK in 1 CARTON (65862-594-10) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK10 blister pack2014-06-020000-00-00NoNoCurrent
65862-594-22658620594222000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BAG (65862-594-22)02-JUN-14Current
65862-594-606586205946060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-594-60) 2014-06-020000-00-00NoNoCurrent
65862-594-99658620594991000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-594-99) 2014-06-020000-00-00NoNoCurrent