divalproex sodium

Product NDC
81469-492
11-digit product format
814690492
Labeler code
81469
Product ID
81469-492_d1c863b8-f352-47bd-82dc-74969d1073c7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
divalproex sodium
Dosage form
CAPSULE, COATED PELLETS
Route
ORAL
Labeler
First Nation Group, LLC
Application
ANDA217358
Marketing category
ANDA
Marketing start
2025-11-10
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
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 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
81469-492-01divalproex sodium100 in 1 BOTTLECAPSULE, COATED PELLETS1002
81469-492-10divalproex sodium1000 in 1 BOTTLECAPSULE, COATED PELLETS10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81469-492-01EA - Each81469-49214072857-b5e0-4316-8328-a52c50324bc612025-12-16
81469-492-10EA - Each81469-492386ea6db-ef06-42c6-8e65-dd0d884dd54b12025-12-16

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099596divalproex sodium 125 MG Delayed Release Oral CapsulePSNa76f9909-28c9-4eb7-8ffd-ff6222fea0792
1099596divalproex sodium 125 MG Delayed Release Oral CapsuleSCDa76f9909-28c9-4eb7-8ffd-ff6222fea0792

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
81469-492-0181469049201100 CAPSULE, COATED PELLETS in 1 BOTTLE (81469-492-01) 2025-11-10NoNoHistorical
81469-492-10814690492101000 CAPSULE, COATED PELLETS in 1 BOTTLE (81469-492-10) 2025-11-10NoNoHistorical