FDA.reportPublic FDA data

Divalproex sodium

Product NDC
71335-2535
11-digit product format
713352535
Labeler code
71335
Product ID
71335-2535_41db30e4-4563-57fd-e063-6294a90a4cfe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex sodium
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA215527
Marketing category
ANDA
Marketing start
2023-09-26
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
Rxcui1099569

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
71335-2535-1Divalproex sodium60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE602
71335-2535-2Divalproex sodium30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE302
71335-2535-3Divalproex sodium90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE902
71335-2535-4Divalproex sodium100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2535DIVALPROEX SODIUM (DIVALPROEX SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]1Current NDC, 4 package rows20241212_d524db34-99c4-4837-a532-a619f82c21ba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099569divalproex sodium 500 MG 24HR Extended Release Oral TabletPSNd524db34-99c4-4837-a532-a619f82c21ba2
109956924 HR divalproex sodium 500 MG Extended Release Oral TabletSCDd524db34-99c4-4837-a532-a619f82c21ba2
1099569divalproex sodium 500 MG 24 HR Extended Release Oral TabletSYd524db34-99c4-4837-a532-a619f82c21ba2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2535-17133525350160 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-2535-1) 2024-12-10NoNoHistorical
71335-2535-27133525350230 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-2535-2) 2024-12-10NoNoHistorical
71335-2535-37133525350390 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-2535-3) 2024-12-10NoNoHistorical
71335-2535-471335253504100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-2535-4) 2024-12-10NoNoHistorical