FDA.reportPublic FDA data

divalproex sodium

Product NDC
68001-646
11-digit product format
680010646
Labeler code
68001
Product ID
68001-646_5257a09f-879a-dd24-e063-6394a90a0eb7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
divalproex sodium
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
BluePoint Laboratories
Application
ANDA214643
Marketing category
ANDA
Marketing start
2025-06-06
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
68001-646-00divalproex sodium100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1004
68001-646-03divalproex sodium500 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE5004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-646-00EA - Each68001-64619b46acf-0843-42e1-b6b4-517c668b1ffe12025-06-13
68001-646-03EA - Each68001-646760e0b1f-8c4f-4c14-982b-b722c8c9f61812025-06-13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099563divalproex sodium 250 MG 24HR Extended Release Oral TabletPSN352b4c3c-e419-4827-9e00-febb0164e0f54
1099569divalproex sodium 500 MG 24HR Extended Release Oral TabletPSN352b4c3c-e419-4827-9e00-febb0164e0f54
109956324 HR divalproex sodium 250 MG Extended Release Oral TabletSCD352b4c3c-e419-4827-9e00-febb0164e0f54
109956924 HR divalproex sodium 500 MG Extended Release Oral TabletSCD352b4c3c-e419-4827-9e00-febb0164e0f54
1099563divalproex sodium 250 MG 24 HR Extended Release Oral TabletSY352b4c3c-e419-4827-9e00-febb0164e0f54
1099569divalproex sodium 500 MG 24 HR Extended Release Oral TabletSY352b4c3c-e419-4827-9e00-febb0164e0f54
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 formatDescriptionMarketing startSampleExclude flagStatus
68001-646-0068001064600100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68001-646-00) 2025-08-07NoNoCurrent
68001-646-0368001064603500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68001-646-03) 2025-07-10NoNoCurrent