Divalproex sodium

Product NDC
72603-260
11-digit product format
726030260
Labeler code
72603
Product ID
72603-260_7306e665-f551-db56-f79a-624d7cd1225b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex sodium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
NorthStar Rx LLC
Application
ANDA078979
Marketing category
ANDA
Marketing start
2024-08-01
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
72603-260-01Divalproex sodium100 in 1 BOTTLECAPSULE, DELAYED RELEASE1003
72603-260-02Divalproex sodium500 in 1 BOTTLECAPSULE, DELAYED RELEASE5003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-260-01EA - Each72603-260f99345f4-377f-41ae-a24a-8a815301311512024-10-04
72603-260-02EA - Each72603-260fda28ce2-1c98-457a-8b4f-82d842891c8212024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-260DIVALPROEX SODIUM CAPSULE, DELAYED RELEASE [NORTHSTAR RX LLC]2Current NDC, 2 package rows20250223_589ae3a6-8b2e-d931-d36b-1937287ab5c0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099596divalproex sodium 125 MG Delayed Release Oral CapsulePSN589ae3a6-8b2e-d931-d36b-1937287ab5c03
1099596divalproex sodium 125 MG Delayed Release Oral CapsuleSCD589ae3a6-8b2e-d931-d36b-1937287ab5c03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72603-260-0172603026001100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (72603-260-01) 2024-08-01NoNoCurrent
72603-260-0272603026002500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (72603-260-02) 2024-08-01NoNoCurrent