FDA.reportPublic FDA data

Divalproex Sodium

Product NDC
71610-311
11-digit product format
716100311
Labeler code
71610
Product ID
71610-311_5972f31b-7143-4432-ae2e-96d8508ceb05
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex Sodium
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA203730
Marketing category
ANDA
Marketing start
2015-06-01
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
2020-12-31
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
71610-311-532023-01-30C16284748780-1f386c64a-051c-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS. DIVALPROEX sodium extended-release tablets, for oral use Initial U.S. Approval: 2000
71610-311-602023-01-30C16284748780-1f386c64a-051c-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS. DIVALPROEX sodium extended-release tablets, for oral use Initial U.S. Approval: 2000
71610-311-702023-01-30C16284748780-1f386c64a-051c-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS. DIVALPROEX sodium extended-release tablets, for oral use Initial U.S. Approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-311-53Divalproex Sodium60 in 1 BOTTLETABLET, EXTENDED RELEASE601
71610-311-60Divalproex Sodium90 in 1 BOTTLETABLET, EXTENDED RELEASE901
71610-311-70Divalproex Sodium120 in 1 BOTTLETABLET, EXTENDED RELEASE1201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-311-53EA - Each71610-3111a5194c3-5f9f-42b3-bf0a-dbf599b28c8912019-10-07
71610-311-60EA - Each71610-3117d5b2954-c34d-40c5-a863-54ee5f1cad8012019-10-07
71610-311-70EA - Each71610-311f05ae575-9ea0-4939-b304-516945d6650912019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-311DIVALPROEX SODIUM TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 3 package rows20190831_fe30c8da-0ae4-48d0-9c0f-9b9d0d726904.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099569divalproex sodium 500 MG 24HR Extended Release Oral TabletPSNfe30c8da-0ae4-48d0-9c0f-9b9d0d7269041
109956924 HR divalproex sodium 500 MG Extended Release Oral TabletSCDfe30c8da-0ae4-48d0-9c0f-9b9d0d7269041
1099569divalproex sodium 500 MG 24 HR Extended Release Oral TabletSYfe30c8da-0ae4-48d0-9c0f-9b9d0d7269041

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-311-537161003115360 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-311-53) 2019-08-020000-00-00NoNoCurrent
71610-311-607161003116090 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-311-60) 2019-08-020000-00-00NoNoCurrent
71610-311-7071610031170120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-311-70) 2019-08-020000-00-00NoNoCurrent