Divalproex Sodium

Product NDC
58118-0040
11-digit product format
581180040
Labeler code
58118
Product ID
58118-0040_b0105f6d-7540-06ba-e053-2995a90af6f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Clinical Solutions Wholesale, LLC
Application
ANDA079163
Marketing category
ANDA
Marketing start
2011-10-01
Marketing end
0000-00-00
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
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58118-0040-82024-01-30C16284748780-11030e365-4180-111a-e063-dadaa90a10e2d494b0c9-4f73-44d0-99e9-c7cd3711d665

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIVALPROEX SODIUMACTIVE INGREDIENT644VL95AO6DIVALPROEX SODIUM TABLET, DELAYED RELEASE [CLINICAL SOLUTIONS WHOLESALE, LLC]2
VALPROIC ACIDACTIVE MOIETY614OI1Z5WIDIVALPROEX SODIUM TABLET, DELAYED RELEASE [CLINICAL SOLUTIONS WHOLESALE, LLC]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MDIVALPROEX SODIUM TABLET, DELAYED RELEASE [CLINICAL SOLUTIONS WHOLESALE, LLC]2
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3DIVALPROEX SODIUM TABLET, DELAYED RELEASE [CLINICAL SOLUTIONS WHOLESALE, LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIVALPROEX SODIUM TABLET, DELAYED RELEASE [CLINICAL SOLUTIONS WHOLESALE, LLC]2
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BDIVALPROEX SODIUM TABLET, DELAYED RELEASE [CLINICAL SOLUTIONS WHOLESALE, LLC]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDIVALPROEX SODIUM TABLET, DELAYED RELEASE [CLINICAL SOLUTIONS WHOLESALE, LLC]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADIVALPROEX SODIUM TABLET, DELAYED RELEASE [CLINICAL SOLUTIONS WHOLESALE, LLC]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DIVALPROEX SODIUM TABLET, DELAYED RELEASE [CLINICAL SOLUTIONS WHOLESALE, LLC]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DIVALPROEX SODIUM TABLET, DELAYED RELEASE [CLINICAL SOLUTIONS WHOLESALE, LLC]2
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6DIVALPROEX SODIUM TABLET, DELAYED RELEASE [CLINICAL SOLUTIONS WHOLESALE, LLC]2
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302DIVALPROEX SODIUM TABLET, DELAYED RELEASE [CLINICAL SOLUTIONS WHOLESALE, LLC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDIVALPROEX SODIUM TABLET, DELAYED RELEASE [CLINICAL SOLUTIONS WHOLESALE, LLC]2
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JDIVALPROEX SODIUM TABLET, DELAYED RELEASE [CLINICAL SOLUTIONS WHOLESALE, LLC]2
POLYETHYLENE GLYCOL 3000INACTIVE INGREDIENTSA1B764746DIVALPROEX SODIUM TABLET, DELAYED RELEASE [CLINICAL SOLUTIONS WHOLESALE, LLC]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DIVALPROEX SODIUM TABLET, DELAYED RELEASE [CLINICAL SOLUTIONS WHOLESALE, LLC]2
SHELLACINACTIVE INGREDIENT46N107B71ODIVALPROEX SODIUM TABLET, DELAYED RELEASE [CLINICAL SOLUTIONS WHOLESALE, LLC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIVALPROEX SODIUM TABLET, DELAYED RELEASE [CLINICAL SOLUTIONS WHOLESALE, LLC]2
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QODIVALPROEX SODIUM TABLET, DELAYED RELEASE [CLINICAL SOLUTIONS WHOLESALE, LLC]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDIVALPROEX SODIUM TABLET, DELAYED RELEASE [CLINICAL SOLUTIONS WHOLESALE, LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDIVALPROEX SODIUM TABLET, DELAYED RELEASE [CLINICAL SOLUTIONS WHOLESALE, LLC]2
TALCINACTIVE INGREDIENT7SEV7J4R1UDIVALPROEX SODIUM TABLET, DELAYED RELEASE [CLINICAL SOLUTIONS WHOLESALE, LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDIVALPROEX SODIUM TABLET, DELAYED RELEASE [CLINICAL SOLUTIONS WHOLESALE, LLC]2
TRIACETININACTIVE INGREDIENTXHX3C3X673DIVALPROEX SODIUM TABLET, DELAYED RELEASE [CLINICAL SOLUTIONS WHOLESALE, LLC]2
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMDIVALPROEX SODIUM TABLET, DELAYED RELEASE [CLINICAL SOLUTIONS WHOLESALE, LLC]2
VANILLININACTIVE INGREDIENTCHI530446XDIVALPROEX SODIUM TABLET, DELAYED RELEASE [CLINICAL SOLUTIONS WHOLESALE, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58118-0040DIVALPROEX SODIUM TABLET, DELAYED RELEASE [CLINICAL SOLUTIONS WHOLESALE, LLC]8Legacy NDC20200925_d494b0c9-4f73-44d0-99e9-c7cd3711d665.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
58118-0040-85811800400830 TABLET, DELAYED RELEASE in 1 BLISTER PACK (58118-0040-8) 2015-08-210000-00-00NoNoCurrent