Divalproex sodium

Product NDC
72162-2516
11-digit product format
721622516
Labeler code
72162
Product ID
72162-2516_f88bd40f-33f3-41a2-b271-7f031b3c7fd7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex sodium
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202419
Marketing category
ANDA
Marketing start
2014-06-02
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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
57fc3d01-4737-4091-9728-9e8a4c9e708dProduct name120200121
5d67ecc7-47c7-ec5e-e9eb-71bf00250645Product name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
97fce1a8-50c4-f088-0e31-64d82b6e9081Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-2516-1Divalproex sodium100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE100101
72162-2516-5Divalproex sodium500 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE500101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2516-1EA - Each72162-25163b8ca6df-df59-4d25-b406-47f1fe4fe79b12025-07-08
72162-2516-5EA - Each72162-251614b2b42c-c8f1-4b64-a99b-ce91c9e77c0a12025-07-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099569divalproex sodium 500 MG 24HR Extended Release Oral TabletPSN0669ac77-10df-48af-bc42-55e768b69e4f101
109956924 HR divalproex sodium 500 MG Extended Release Oral TabletSCD0669ac77-10df-48af-bc42-55e768b69e4f101
1099569divalproex sodium 500 MG 24 HR Extended Release Oral TabletSY0669ac77-10df-48af-bc42-55e768b69e4f101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-2516-172162251601100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72162-2516-1) 2025-06-09NoNoHistorical
72162-2516-572162251605500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72162-2516-5) 2025-06-09NoNoHistorical