Divalproex sodium

Product NDC
55154-3552
11-digit product format
551543552
Labeler code
55154
Product ID
55154-3552_ade35d14-d552-467d-9bfd-7d65b1d6cbf6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex sodium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA078979
Marketing category
ANDA
Marketing start
2009-01-23
Substance
DIVALPROEX SODIUM
Active strength
125 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 SODIUM125 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii644VL95AO6
Rxcui1099596

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
55154-3552-0Divalproex sodium1 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE17
55154-3552-0Divalproex sodium10 in 1 BAGCAPSULE, DELAYED RELEASE107

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-3552DIVALPROEX SODIUM CAPSULE, DELAYED RELEASE [CARDINAL HEALTH 107, LLC]4Current NDC, Legacy NDC, 2 package rows20250503_0816a066-9ee3-4c23-944d-3539fc2c12bf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099596divalproex sodium 125 MG Delayed Release Oral CapsulePSN0816a066-9ee3-4c23-944d-3539fc2c12bf7
1099596divalproex sodium 125 MG Delayed Release Oral CapsuleSCD0816a066-9ee3-4c23-944d-3539fc2c12bf7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-3552-05515435520010 BLISTER PACK in 1 BAG (55154-3552-0) / 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK10 blister pack2009-01-230000-00-00NoNoCurrent