divalproex sodium

Product NDC
67046-1647
11-digit product format
670461647
Labeler code
67046
Product ID
67046-1647_4834727a-982f-9ba7-e063-6394a90a8180
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
divalproex sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Coupler LLC
Application
ANDA078853
Marketing category
ANDA
Marketing start
2024-06-26
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
Rxcui1099870

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
67046-1647-3divalproex sodium30 in 1 BLISTER PACKTABLET, DELAYED RELEASE301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099870divalproex sodium 500 MG Delayed Release Oral TabletPSN4834732f-6044-946c-e063-6394a90a5da31
1099870divalproex sodium 500 MG Delayed Release Oral TabletSCD4834732f-6044-946c-e063-6394a90a5da31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
67046-1647-36704616470330 TABLET, DELAYED RELEASE in 1 BLISTER PACK (67046-1647-3) 2024-06-26NoNoHistorical