FDA.reportPublic FDA data

divalproex sodium

Product NDC
71335-2783
11-digit product format
713352783
Labeler code
71335
Product ID
71335-2783_ab939570-1437-4742-952e-a93d011d0c05
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
divalproex sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078853
Marketing category
ANDA
Marketing start
2024-06-26
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
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
divalproex sodium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIVALPROEX SODIUM250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii644VL95AO6
Rxcui1099678

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
71335-2783-1divalproex sodium30 in 1 BOTTLETABLET, DELAYED RELEASE302
71335-2783-2divalproex sodium60 in 1 BOTTLETABLET, DELAYED RELEASE602
71335-2783-3divalproex sodium90 in 1 BOTTLETABLET, DELAYED RELEASE902
71335-2783-4divalproex sodium120 in 1 BOTTLETABLET, DELAYED RELEASE1202
71335-2783-5divalproex sodium100 in 1 BOTTLETABLET, DELAYED RELEASE1002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSNc971b50d-0f78-422f-abee-1c5b4e1d20e72
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCDc971b50d-0f78-422f-abee-1c5b4e1d20e72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2783-17133527830130 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2783-1) 2025-10-13NoNoHistorical
71335-2783-27133527830260 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2783-2) 2025-10-13NoNoHistorical
71335-2783-37133527830390 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2783-3) 2025-10-13NoNoHistorical
71335-2783-471335278304120 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2783-4) 2025-10-13NoNoHistorical
71335-2783-571335278305100 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2783-5) 2025-10-13NoNoHistorical