Divalproex Sodium

Product NDC
64725-0797
11-digit product format
647250797
Labeler code
64725
Product ID
64725-0797_e209f276-8e72-43a3-94e5-aef94ac76054
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
TYA Pharmaceuticals
Application
ANDA078597
Marketing category
ANDA
Marketing start
2008-07-29
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
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
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
57fc3d01-4737-4091-9728-9e8a4c9e708dProduct name120200121
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5d67ecc7-47c7-ec5e-e9eb-71bf00250645Product name120140508
97fce1a8-50c4-f088-0e31-64d82b6e9081Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64725-0797-12019-11-27C16284748780-19855e2a2-331e-60a7-e053-dbdaa90a05bdDIVALPROEX SODIUM DELAYED-RELEASE TABLETS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64725-0797-1Divalproex Sodium15 in 1 CONTAINERTABLET, DELAYED RELEASE154

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIVALPROEX SODIUMACTIVE INGREDIENT644VL95AO6DIVALPROEX SODIUM TABLET, DELAYED RELEASE [TYA PHARMACEUTICALS]4
VALPROIC ACIDACTIVE MOIETY614OI1Z5WIDIVALPROEX SODIUM TABLET, DELAYED RELEASE [TYA PHARMACEUTICALS]4
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BDIVALPROEX SODIUM TABLET, DELAYED RELEASE [TYA PHARMACEUTICALS]4
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDIVALPROEX SODIUM TABLET, DELAYED RELEASE [TYA PHARMACEUTICALS]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DIVALPROEX SODIUM TABLET, DELAYED RELEASE [TYA PHARMACEUTICALS]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DIVALPROEX SODIUM TABLET, DELAYED RELEASE [TYA PHARMACEUTICALS]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDIVALPROEX SODIUM TABLET, DELAYED RELEASE [TYA PHARMACEUTICALS]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODIVALPROEX SODIUM TABLET, DELAYED RELEASE [TYA PHARMACEUTICALS]4
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JDIVALPROEX SODIUM TABLET, DELAYED RELEASE [TYA PHARMACEUTICALS]4
POVIDONE K30INACTIVE INGREDIENTU725QWY32XDIVALPROEX SODIUM TABLET, DELAYED RELEASE [TYA PHARMACEUTICALS]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIVALPROEX SODIUM TABLET, DELAYED RELEASE [TYA PHARMACEUTICALS]4
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QODIVALPROEX SODIUM TABLET, DELAYED RELEASE [TYA PHARMACEUTICALS]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDIVALPROEX SODIUM TABLET, DELAYED RELEASE [TYA PHARMACEUTICALS]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDIVALPROEX SODIUM TABLET, DELAYED RELEASE [TYA PHARMACEUTICALS]4
TALCINACTIVE INGREDIENT7SEV7J4R1UDIVALPROEX SODIUM TABLET, DELAYED RELEASE [TYA PHARMACEUTICALS]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDIVALPROEX SODIUM TABLET, DELAYED RELEASE [TYA PHARMACEUTICALS]4
TRIACETININACTIVE INGREDIENTXHX3C3X673DIVALPROEX SODIUM TABLET, DELAYED RELEASE [TYA PHARMACEUTICALS]4
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMDIVALPROEX SODIUM TABLET, DELAYED RELEASE [TYA PHARMACEUTICALS]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64725-0797DIVALPROEX SODIUM TABLET, DELAYED RELEASE [TYA PHARMACEUTICALS]4Legacy NDC, 1 package rows20140921_0fddf30c-60f0-4d15-b598-ee414988619c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSN0fddf30c-60f0-4d15-b598-ee414988619c4
1099870divalproex sodium 500 MG Delayed Release Oral TabletPSN0fddf30c-60f0-4d15-b598-ee414988619c4
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCD0fddf30c-60f0-4d15-b598-ee414988619c4
1099870divalproex sodium 500 MG Delayed Release Oral TabletSCD0fddf30c-60f0-4d15-b598-ee414988619c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
64725-0797-16472507970115 in 1 CONTAINERHistorical