FDA.reportPublic FDA data

Divalproex sodium

Product NDC
0615-8377
11-digit product format
006158377
Labeler code
0615
Product ID
0615-8377_efe6fc7b-e709-4f0d-ba7f-ffb7a87ad155
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex sodium
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA209286
Marketing category
ANDA
Marketing start
2020-09-18
Marketing end
2026-10-31
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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIVALPROEX SODIUM500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii644VL95AO6

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b10a892b-b985-4cbc-9547-9ac4b72b784fProduct name220250818
7a3a03f1-382a-f9ec-0741-ff24dcbfed69Product name720250624
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
57fc3d01-4737-4091-9728-9e8a4c9e708dProduct name120200121
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5d67ecc7-47c7-ec5e-e9eb-71bf00250645Product name120140508
97fce1a8-50c4-f088-0e31-64d82b6e9081Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0615-8377-30Divalproex sodium6 in 1 BOX, UNIT-DOSETABLET, EXTENDED RELEASE66
0615-8377-30Divalproex sodium5 in 1 BLISTER PACKTABLET, EXTENDED RELEASE56
0615-8377-39Divalproex sodium30 in 1 BLISTER PACKTABLET, EXTENDED RELEASE306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-8377DIVALPROEX SODIUM TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]6Current NDC, Legacy NDC, 3 package rows20240915_319bbead-bec8-4bb7-9ecb-b2e161c44b8d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099563divalproex sodium 250 MG 24HR Extended Release Oral TabletPSN319bbead-bec8-4bb7-9ecb-b2e161c44b8d6
1099569divalproex sodium 500 MG 24HR Extended Release Oral TabletPSN319bbead-bec8-4bb7-9ecb-b2e161c44b8d6
109956324 HR divalproex sodium 250 MG Extended Release Oral TabletSCD319bbead-bec8-4bb7-9ecb-b2e161c44b8d6
109956924 HR divalproex sodium 500 MG Extended Release Oral TabletSCD319bbead-bec8-4bb7-9ecb-b2e161c44b8d6
1099563divalproex sodium 250 MG 24 HR Extended Release Oral TabletSY319bbead-bec8-4bb7-9ecb-b2e161c44b8d6
1099569divalproex sodium 500 MG 24 HR Extended Release Oral TabletSY319bbead-bec8-4bb7-9ecb-b2e161c44b8d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0615-8377-30006158377306 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8377-30) > 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK6 blister pack2021-02-090000-00-00NoNoCurrent
0615-8377-390061583773930 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-8377-39) 2021-02-030000-00-00NoNoCurrent