FDA.reportPublic FDA data

Divalproex Sodium

Product NDC
50090-4861
11-digit product format
500904861
Labeler code
50090
Product ID
50090-4861_435409a3-3b85-46fa-bb51-9b6a035e27c6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA079163
Marketing category
ANDA
Marketing start
2011-10-01
Substance
DIVALPROEX SODIUM
Active strength
125 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Divalproex Sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIVALPROEX SODIUM125 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii644VL95AO6
Rxcui1099625

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
50090-4861-02023-02-07C16284748780-1f386c64a-2019-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DIVALPROEX SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for DIVALPROEX SODIUM DELAYED-RELEASE TABLETS. DIVALPROEX SODIUM delayed-release tablets, for oral use Initial U.S. Approval: 1983
50090-4861-02023-01-30C16284748780-1f386c64a-2019-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DIVALPROEX SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for DIVALPROEX SODIUM DELAYED-RELEASE TABLETS. DIVALPROEX SODIUM delayed-release tablets, for oral use Initial U.S. Approval: 1983

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4861-0Divalproex Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE309

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4861DIVALPROEX SODIUM TABLET, DELAYED RELEASE [A-S MEDICATION SOLUTIONS]9Current NDC, Legacy NDC, 1 package rows20240425_c3af30e3-27ff-4285-8e4a-81856f266b32.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099625divalproex sodium 125 MG Delayed Release Oral TabletPSNc3af30e3-27ff-4285-8e4a-81856f266b329
1099625divalproex sodium 125 MG Delayed Release Oral TabletSCDc3af30e3-27ff-4285-8e4a-81856f266b329

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4861-05009048610030 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-4861-0) 2020-01-220000-00-00NoNoCurrent