Divalproex Sodium

Product NDC
67046-121
11-digit product format
670460121
Labeler code
67046
Product ID
67046-121_ea1966a2-794c-434e-a9da-57890bd182fc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA078182
Marketing category
ANDA
Marketing start
2008-07-29
Marketing end
0000-00-00
Substance
DIVALPROEX SODIUM
Active strength
500 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67046-121-302019-10-21C16284748780-1956f9ecf-d788-621f-e053-dbdaa90a74adDivalproex Sodium Delayed-Release Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-121-30Divalproex Sodium30 in 1 BLISTER PACKTABLET, DELAYED RELEASE302

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Divalproex SodiumACTIVE INGREDIENT644VL95AO6DIVALPROEX SODIUM TABLET, DELAYED RELEASE [CONTRACT PHARMACY SERVICES-PA]2
Valproic AcidACTIVE MOIETY614OI1Z5WIDIVALPROEX SODIUM TABLET, DELAYED RELEASE [CONTRACT PHARMACY SERVICES-PA]2
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOADIVALPROEX SODIUM TABLET, DELAYED RELEASE [CONTRACT PHARMACY SERVICES-PA]2
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8DIVALPROEX SODIUM TABLET, DELAYED RELEASE [CONTRACT PHARMACY SERVICES-PA]2
ferric oxide redINACTIVE INGREDIENT1K09F3G675DIVALPROEX SODIUM TABLET, DELAYED RELEASE [CONTRACT PHARMACY SERVICES-PA]2
methacrylic acid - ethyl acrylate copolymer (1:1) type AINACTIVE INGREDIENTNX76LV5T8JDIVALPROEX SODIUM TABLET, DELAYED RELEASE [CONTRACT PHARMACY SERVICES-PA]2
povidoneINACTIVE INGREDIENTFZ989GH94EDIVALPROEX SODIUM TABLET, DELAYED RELEASE [CONTRACT PHARMACY SERVICES-PA]2
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4DIVALPROEX SODIUM TABLET, DELAYED RELEASE [CONTRACT PHARMACY SERVICES-PA]2
sodium bicarbonateINACTIVE INGREDIENT8MDF5V39QODIVALPROEX SODIUM TABLET, DELAYED RELEASE [CONTRACT PHARMACY SERVICES-PA]2
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JDIVALPROEX SODIUM TABLET, DELAYED RELEASE [CONTRACT PHARMACY SERVICES-PA]2
starch, cornINACTIVE INGREDIENTO8232NY3SJDIVALPROEX SODIUM TABLET, DELAYED RELEASE [CONTRACT PHARMACY SERVICES-PA]2
talcINACTIVE INGREDIENT7SEV7J4R1UDIVALPROEX SODIUM TABLET, DELAYED RELEASE [CONTRACT PHARMACY SERVICES-PA]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPDIVALPROEX SODIUM TABLET, DELAYED RELEASE [CONTRACT PHARMACY SERVICES-PA]2
triethyl citrateINACTIVE INGREDIENT8Z96QXD6UMDIVALPROEX SODIUM TABLET, DELAYED RELEASE [CONTRACT PHARMACY SERVICES-PA]2
vanillinINACTIVE INGREDIENTCHI530446XDIVALPROEX SODIUM TABLET, DELAYED RELEASE [CONTRACT PHARMACY SERVICES-PA]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-121DIVALPROEX SODIUM TABLET, DELAYED RELEASE [CONTRACT PHARMACY SERVICES-PA]2Legacy NDC, 1 package rows20100824_ea85f517-4773-4688-88b6-5612612330f6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSNea85f517-4773-4688-88b6-5612612330f62
1099870divalproex sodium 500 MG Delayed Release Oral TabletPSNea85f517-4773-4688-88b6-5612612330f62
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCDea85f517-4773-4688-88b6-5612612330f62
1099870divalproex sodium 500 MG Delayed Release Oral TabletSCDea85f517-4773-4688-88b6-5612612330f62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67046-121-306704601213030 in 1 BLISTER PACKHistorical