FDA.reportPublic FDA data

Divalproex Sodium

Product NDC
71335-2158
11-digit product format
713352158
Labeler code
71335
Product ID
71335-2158_5079c7a7-f979-4b2e-a516-be3c8a9edc03
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090554
Marketing category
ANDA
Marketing start
2014-10-24
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
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 SODIUM500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii644VL95AO6
Rxcui1099870

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2158-1Divalproex Sodium60 in 1 BOTTLETABLET, DELAYED RELEASE60105
71335-2158-2Divalproex Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE30105
71335-2158-3Divalproex Sodium90 in 1 BOTTLETABLET, DELAYED RELEASE90105
71335-2158-4Divalproex Sodium180 in 1 BOTTLETABLET, DELAYED RELEASE180105
71335-2158-5Divalproex Sodium120 in 1 BOTTLETABLET, DELAYED RELEASE120105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2158DIVALPROEX SODIUM TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 5 package rows20240915_fbaff0ae-431e-4e83-81c2-41eb4b18ee87.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099870divalproex sodium 500 MG Delayed Release Oral TabletPSNfbaff0ae-431e-4e83-81c2-41eb4b18ee87105
1099870divalproex sodium 500 MG Delayed Release Oral TabletSCDfbaff0ae-431e-4e83-81c2-41eb4b18ee87105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-2158-17133521580160 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2158-1) 2022-08-110000-00-00NoNoCurrent
71335-2158-27133521580230 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2158-2) 2023-03-020000-00-00NoNoCurrent
71335-2158-37133521580390 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2158-3) 2022-08-110000-00-00NoNoCurrent
71335-2158-471335215804180 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2158-4) 2024-09-060000-00-00NoNoCurrent
71335-2158-571335215805120 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2158-5) 2022-09-200000-00-00NoNoCurrent