FDA.reportPublic FDA data

divalproex sodium

Product NDC
60687-904
11-digit product format
606870904
Labeler code
60687
Product ID
60687-904_47e2f52f-946b-05e5-e063-6294a90a5a59
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
divalproex sodium
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA214643
Marketing category
ANDA
Marketing start
2025-12-18
Substance
DIVALPROEX SODIUM
Active strength
250 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 SODIUM250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii644VL95AO6
Rxcui1099563, 1099569

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
60687-904-01divalproex sodium100 in 1 CARTONTABLET, FILM COATED, EXTENDED RE1003
60687-904-11divalproex sodium1 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-904-01EA - Each60687-904341cbca5-cc8f-49bb-a139-408c562543b412025-12-16
60687-904-11EA - Each60687-9041b1ac129-0f23-4343-97af-be6a11a3589e12025-12-16

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099563divalproex sodium 250 MG 24HR Extended Release Oral TabletPSNb12b76a0-4b6e-4cd4-9508-10a2c84d8beb3
1099569divalproex sodium 500 MG 24HR Extended Release Oral TabletPSNb12b76a0-4b6e-4cd4-9508-10a2c84d8beb3
109956324 HR divalproex sodium 250 MG Extended Release Oral TabletSCDb12b76a0-4b6e-4cd4-9508-10a2c84d8beb3
109956924 HR divalproex sodium 500 MG Extended Release Oral TabletSCDb12b76a0-4b6e-4cd4-9508-10a2c84d8beb3
1099563divalproex sodium 250 MG 24 HR Extended Release Oral TabletSYb12b76a0-4b6e-4cd4-9508-10a2c84d8beb3
1099569divalproex sodium 500 MG 24 HR Extended Release Oral TabletSYb12b76a0-4b6e-4cd4-9508-10a2c84d8beb3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60687-904-0160687090401100 BLISTER PACK in 1 CARTON (60687-904-01) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (60687-904-11) 100 blister pack2025-12-18NoNoHistorical
60687-904-11606870904111 in 1 BLISTER PACKHistorical