FDA.reportPublic FDA data

Depakote

Product NDC
43353-310
11-digit product format
433530310
Labeler code
43353
Product ID
43353-310_ca87b71c-a13f-4675-b686-e8af41f108b4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex Sodium
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
NDA021168
Marketing category
NDA
Marketing start
2000-08-04
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
No
Listing certified through
2019-12-31
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
43353-310-532020-01-31C16284748780-19d75b9d1-2a8d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Depakote ER safely and effectively. See full prescribing information for Depakote ER. Depakote ER (divalproex sodium) Tablet, Extended Release for Oral use Initial U.S. Approval: 2000
43353-310-602020-01-31C16284748780-19d75b9d1-2a8d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Depakote ER safely and effectively. See full prescribing information for Depakote ER. Depakote ER (divalproex sodium) Tablet, Extended Release for Oral use Initial U.S. Approval: 2000
43353-310-702020-01-31C16284748780-19d75b9d1-2a8d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Depakote ER safely and effectively. See full prescribing information for Depakote ER. Depakote ER (divalproex sodium) Tablet, Extended Release for Oral use Initial U.S. Approval: 2000
43353-310-802020-01-31C16284748780-19d75b9d1-2a8d-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Depakote ER safely and effectively. See full prescribing information for Depakote ER. Depakote ER (divalproex sodium) Tablet, Extended Release for Oral use Initial U.S. Approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-310-53DepakoteER60 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE601
43353-310-60DepakoteER90 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE901
43353-310-70DepakoteER120 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE1201
43353-310-80DepakoteER180 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-310-53EA - Each43353-3109e1afd07-bc4f-4885-a471-501d8e4d68d512014-08-01
43353-310-60EA - Each43353-3106d81c98f-4d6e-4624-8b29-d06303da8cf312014-08-01
43353-310-70EA - Each43353-310e8d8939a-6671-4d09-96ab-2be0e9b095ab12014-08-01
43353-310-80EA - Each43353-31053382126-3b2b-4f27-b443-16d86e2f52dd12014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIVALPROEX SODIUMACTIVE INGREDIENT644VL95AO6DEPAKOTE ER (DIVALPROEX SODIUM) TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
VALPROIC ACIDACTIVE MOIETY614OI1Z5WIDEPAKOTE ER (DIVALPROEX SODIUM) TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-310DEPAKOTE ER (DIVALPROEX SODIUM) TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 4 package rows20140410_7bc942e3-b976-4b5c-8874-2a1c7dd3d2f1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099571Depakote ER 500 MG 24HR Extended Release Oral TabletPSN7bc942e3-b976-4b5c-8874-2a1c7dd3d2f11
1099569divalproex sodium 500 MG 24HR Extended Release Oral TabletPSN7bc942e3-b976-4b5c-8874-2a1c7dd3d2f11
109957124 HR divalproex sodium 500 MG Extended Release Oral Tablet [Depakote]SBD7bc942e3-b976-4b5c-8874-2a1c7dd3d2f11
109956924 HR divalproex sodium 500 MG Extended Release Oral TabletSCD7bc942e3-b976-4b5c-8874-2a1c7dd3d2f11
109957124 HR Depakote 500 MG Extended Release Oral TabletSY7bc942e3-b976-4b5c-8874-2a1c7dd3d2f11
1099571Depakote 500 MG 24 HR Extended Release Oral TabletSY7bc942e3-b976-4b5c-8874-2a1c7dd3d2f11
1099569divalproex sodium 500 MG 24 HR Extended Release Oral TabletSY7bc942e3-b976-4b5c-8874-2a1c7dd3d2f11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
43353-310-534335303105360 in 1 BOTTLE, PLASTICHistorical
43353-310-604335303106090 in 1 BOTTLE, PLASTICHistorical
43353-310-7043353031070120 in 1 BOTTLE, PLASTICHistorical
43353-310-8043353031080180 in 1 BOTTLE, PLASTICHistorical