FDA.reportPublic FDA data

Divalproex Sodium

Product NDC
55154-2345
11-digit product format
551542345
Labeler code
55154
Product ID
55154-2345_e706c37e-642d-4b19-a0d4-325fa6e6df41
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex Sodium
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA203730
Marketing category
ANDA
Marketing start
2015-06-01
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
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 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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
55154-2345-0Divalproex Sodium1 in 1 BLISTER PACKTABLET, EXTENDED RELEASE16
55154-2345-0Divalproex Sodium10 in 1 BAGTABLET, EXTENDED RELEASE106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-2345DIVALPROEX SODIUM TABLET, EXTENDED RELEASE [CARDINAL HEALTH 107, LLC]3Current NDC, 2 package rows20241226_283af6d2-8ea2-4225-b2e7-a2057dbdb793.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099569divalproex sodium 500 MG 24HR Extended Release Oral TabletPSN283af6d2-8ea2-4225-b2e7-a2057dbdb7936
109956924 HR divalproex sodium 500 MG Extended Release Oral TabletSCD283af6d2-8ea2-4225-b2e7-a2057dbdb7936
1099569divalproex sodium 500 MG 24 HR Extended Release Oral TabletSY283af6d2-8ea2-4225-b2e7-a2057dbdb7936

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55154-2345-05515423450010 BLISTER PACK in 1 BAG (55154-2345-0) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK10 blister pack2015-06-01NoNoHistorical