divalproex sodium

Product NDC
50090-7841
11-digit product format
500907841
Labeler code
50090
Product ID
50090-7841_21277d3e-ee56-48ad-a2b2-015dae50b6e9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
divalproex sodium
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA214643
Marketing category
ANDA
Marketing start
2022-02-25
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
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
50090-7841-0divalproex sodium30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE301
50090-7841-1divalproex sodium90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE901

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099569divalproex sodium 500 MG 24HR Extended Release Oral TabletPSNe5fcf5b1-263e-43e0-9424-e613d5cca3fa1
109956924 HR divalproex sodium 500 MG Extended Release Oral TabletSCDe5fcf5b1-263e-43e0-9424-e613d5cca3fa1
1099569divalproex sodium 500 MG 24 HR Extended Release Oral TabletSYe5fcf5b1-263e-43e0-9424-e613d5cca3fa1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7841-05009078410030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-7841-0) 2025-12-29NoNoCurrent
50090-7841-15009078410190 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-7841-1) 2025-12-29NoNoCurrent