FDA.reportPublic FDA data

Divalproex Sodium

Product NDC
68180-265
11-digit product format
681800265
Labeler code
68180
Product ID
68180-265_0a9f300c-ee8c-43c4-bccf-78cd862a7ac2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA078790
Marketing category
ANDA
Marketing start
2008-07-29
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
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
68180-265-01Divalproex Sodium100 in 1 BOTTLETABLET, DELAYED RELEASE10028
68180-265-02Divalproex Sodium500 in 1 BOTTLETABLET, DELAYED RELEASE50028
68180-265-11Divalproex Sodium10 in 1 BLISTER PACKTABLET, DELAYED RELEASE1028

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-265-01EA - Each68180-265f57c8089-1a9b-4a03-a247-5913c7776f4012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIVALPROEX SODIUMACTIVE INGREDIENT644VL95AO6DIVALPROEX SODIUM TABLET, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]8
VALPROIC ACIDACTIVE MOIETY614OI1Z5WIDIVALPROEX SODIUM TABLET, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIVALPROEX SODIUM TABLET, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]8
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BDIVALPROEX SODIUM TABLET, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]8
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDIVALPROEX SODIUM TABLET, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]8
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDIVALPROEX SODIUM TABLET, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]8
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DIVALPROEX SODIUM TABLET, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]8
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PDIVALPROEX SODIUM TABLET, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]8
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14DIVALPROEX SODIUM TABLET, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]8
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)INACTIVE INGREDIENT87Y6436BKRDIVALPROEX SODIUM TABLET, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]8
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODIVALPROEX SODIUM TABLET, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIVALPROEX SODIUM TABLET, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]8
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DIVALPROEX SODIUM TABLET, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]8
SHELLACINACTIVE INGREDIENT46N107B71ODIVALPROEX SODIUM TABLET, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIVALPROEX SODIUM TABLET, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]8
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJDIVALPROEX SODIUM TABLET, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]8
TALCINACTIVE INGREDIENT7SEV7J4R1UDIVALPROEX SODIUM TABLET, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDIVALPROEX SODIUM TABLET, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]8
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMDIVALPROEX SODIUM TABLET, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]8
DIVALPROEX SODIUMACTIVE INGREDIENT644VL95AO6DIVALPROEX SODIUM DR (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
VALPROIC ACIDACTIVE MOIETY614OI1Z5WIDIVALPROEX SODIUM DR (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIVALPROEX SODIUM DR (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BDIVALPROEX SODIUM DR (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDIVALPROEX SODIUM DR (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DIVALPROEX SODIUM DR (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PDIVALPROEX SODIUM DR (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14DIVALPROEX SODIUM DR (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODIVALPROEX SODIUM DR (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIVALPROEX SODIUM DR (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DIVALPROEX SODIUM DR (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
SHELLACINACTIVE INGREDIENT46N107B71ODIVALPROEX SODIUM DR (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIVALPROEX SODIUM DR (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDIVALPROEX SODIUM DR (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
TALCINACTIVE INGREDIENT7SEV7J4R1UDIVALPROEX SODIUM DR (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDIVALPROEX SODIUM DR (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMDIVALPROEX SODIUM DR (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-265DIVALPROEX SODIUM TABLET, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]26Current NDC, Legacy NDC, 3 package rows20250321_33798a7c-c5a9-49a5-be5d-1312910ef468.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099625divalproex sodium 125 MG Delayed Release Oral TabletPSN33798a7c-c5a9-49a5-be5d-1312910ef46828
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSN33798a7c-c5a9-49a5-be5d-1312910ef46828
1099870divalproex sodium 500 MG Delayed Release Oral TabletPSN33798a7c-c5a9-49a5-be5d-1312910ef46828
1099625divalproex sodium 125 MG Delayed Release Oral TabletSCD33798a7c-c5a9-49a5-be5d-1312910ef46828
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCD33798a7c-c5a9-49a5-be5d-1312910ef46828
1099870divalproex sodium 500 MG Delayed Release Oral TabletSCD33798a7c-c5a9-49a5-be5d-1312910ef46828

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68180-265-0168180026501100 TABLET, DELAYED RELEASE in 1 BOTTLE (68180-265-01) 2008-07-290000-00-00NoNoCurrent
68180-265-0268180026502500 TABLET, DELAYED RELEASE in 1 BOTTLE (68180-265-02) 2008-07-290000-00-00NoNoCurrent
68180-265-116818002651110 TABLET, DELAYED RELEASE in 1 BLISTER PACK (68180-265-11) 2008-07-290000-00-00NoNoCurrent