Divalproex sodium

Product NDC
0615-8237
11-digit product format
006158237
Labeler code
0615
Product ID
0615-8237_9acc51b3-fd1c-48a4-b620-689c38545dd5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex sodium
Dosage form
CAPSULE
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
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
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 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
0615-8237-05Divalproex sodium15 in 1 BLISTER PACKCAPSULE1528
0615-8237-28Divalproex sodium28 in 1 BLISTER PACKCAPSULE2828
0615-8237-30Divalproex sodium6 in 1 BOX, UNIT-DOSECAPSULE628
0615-8237-30Divalproex sodium5 in 1 BLISTER PACKCAPSULE528
0615-8237-39Divalproex sodium30 in 1 BLISTER PACKCAPSULE3028

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-8237DIVALPROEX SODIUM CAPSULE [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]28Current NDC, Legacy NDC, 5 package rows20240919_388fd4bc-f12f-4e55-a1e7-72aa585519fa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099596divalproex sodium 125 MG Delayed Release Oral CapsulePSN388fd4bc-f12f-4e55-a1e7-72aa585519fa28
1099596divalproex sodium 125 MG Delayed Release Oral CapsuleSCD388fd4bc-f12f-4e55-a1e7-72aa585519fa28

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0615-8237-050061582370515 CAPSULE in 1 BLISTER PACK (0615-8237-05) 15 capsule2018-08-270000-00-00NoNoCurrent
0615-8237-280061582372828 CAPSULE in 1 BLISTER PACK (0615-8237-28) 28 capsule2024-04-19NoNoCurrent
0615-8237-30006158237306 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8237-30) / 5 CAPSULE in 1 BLISTER PACK6 blister pack2018-08-270000-00-00NoNoCurrent
0615-8237-390061582373930 CAPSULE in 1 BLISTER PACK (0615-8237-39) 30 capsule2018-08-270000-00-00NoNoCurrent