FDA.reportPublic FDA data

Divalproex sodium

Product NDC
64725-0595
11-digit product format
647250595
Labeler code
64725
Product ID
64725-0595_c99e62c9-59d6-4461-a36d-ec6127d3954d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex sodium
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
TYA Pharmaceuticals
Application
ANDA202419
Marketing category
ANDA
Marketing start
2014-06-02
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
64725-0595-12019-11-27C16284748780-19855e2a2-4f17-60a7-e053-dbdaa90a05bdThese highlights do not include all the information needed to use divalproex sodium extended-release tablets USP safely and effectively. See full prescribing information for divalproex sodium extended-release tablets USP. DIVALPROEX Sodium Extended-Release Tablets USP, for Oral Use Initial U.S. Approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64725-0595-1Divalproex sodium68 in 1 CONTAINERTABLET, FILM COATED, EXTENDED RE682

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64725-0595DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [TYA PHARMACEUTICALS]2Legacy NDC, 1 package rows20140904_874a4fba-f0cd-424a-9407-11d2526a41c5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099569divalproex sodium 500 MG 24HR Extended Release Oral TabletPSN874a4fba-f0cd-424a-9407-11d2526a41c52
109956924 HR divalproex sodium 500 MG Extended Release Oral TabletSCD874a4fba-f0cd-424a-9407-11d2526a41c52
1099569divalproex sodium 500 MG 24 HR Extended Release Oral TabletSY874a4fba-f0cd-424a-9407-11d2526a41c52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
64725-0595-16472505950168 in 1 CONTAINERHistorical