FDA.reportPublic FDA data

divalproex sodium

Product NDC
71335-2782
11-digit product format
713352782
Labeler code
71335
Product ID
71335-2782_059c400c-3e48-4eda-957a-3881b9907ddf
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
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
71335-2782-1divalproex sodium60 in 1 BOTTLETABLET, DELAYED RELEASE601
71335-2782-2divalproex sodium30 in 1 BOTTLETABLET, DELAYED RELEASE301
71335-2782-3divalproex sodium90 in 1 BOTTLETABLET, DELAYED RELEASE901
71335-2782-4divalproex sodium180 in 1 BOTTLETABLET, DELAYED RELEASE1801
71335-2782-5divalproex sodium120 in 1 BOTTLETABLET, DELAYED RELEASE1201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2782-1EA - Each71335-2782db56f954-da75-45ac-8218-da1011c3029c12025-10-14

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099870divalproex sodium 500 MG Delayed Release Oral TabletPSNdf8f3825-a037-4343-859d-e59bca5f1e431
1099870divalproex sodium 500 MG Delayed Release Oral TabletSCDdf8f3825-a037-4343-859d-e59bca5f1e431

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2782-17133527820160 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2782-1) 2025-09-24NoNoHistorical
71335-2782-27133527820230 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2782-2) 2025-09-24NoNoHistorical
71335-2782-37133527820390 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2782-3) 2025-09-24NoNoHistorical
71335-2782-471335278204180 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2782-4) 2025-09-24NoNoHistorical
71335-2782-571335278205120 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2782-5) 2025-09-24NoNoHistorical