Divalproex Sodium ER

Product NDC
72189-459
11-digit product format
721890459
Labeler code
72189
Product ID
72189-459_2c4dbb36-4841-f211-e063-6294a90ad364
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex Sodium ER
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Direct_Rx
Application
ANDA209286
Marketing category
ANDA
Marketing start
2023-04-03
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 ER
Listing expiration
2026-12-31

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
72189-459-60Divalproex Sodium ER60 in 1 BOTTLETABLET, EXTENDED RELEASE602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-459-60EA - Each72189-459a30b1cc6-73e5-4766-92a0-11f7989f690c12023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-459DIVALPROEX SODIUM ER TABLET, EXTENDED RELEASE [DIRECT_RX]2Current NDC, 1 package rows20250123_f86f185b-4acb-43b5-e053-6394a90a681c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099569divalproex sodium 500 MG 24HR Extended Release Oral TabletPSNf86f185b-4acb-43b5-e053-6394a90a681c2
109956924 HR divalproex sodium 500 MG Extended Release Oral TabletSCDf86f185b-4acb-43b5-e053-6394a90a681c2
1099569divalproex sodium 500 MG 24 HR Extended Release Oral TabletSYf86f185b-4acb-43b5-e053-6394a90a681c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72189-459-607218904596060 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-459-60) 2023-04-03NoNoCurrent