divalproex sodium

Product NDC
68788-4079
11-digit product format
687884079
Labeler code
68788
Product ID
68788-4079_dbd1d178-77a3-46ff-985d-307dffaed1ad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
divalproex sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA078853
Marketing category
ANDA
Marketing start
2026-02-17
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
Rxcui1099678

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
68788-4079-3divalproex sodium30 in 1 BOTTLETABLET, DELAYED RELEASE301
68788-4079-6divalproex sodium60 in 1 BOTTLETABLET, DELAYED RELEASE601
68788-4079-9divalproex sodium90 in 1 BOTTLETABLET, DELAYED RELEASE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-4079-3EA - Each68788-4079eaf54bbb-9cd3-442d-b035-3ed1abe7272c12026-04-20
68788-4079-6EA - Each68788-4079c536cfc5-92c4-4698-a1ef-79bf06ac1ddc12026-04-20
68788-4079-9EA - Each68788-40790e73b3d4-63b1-41f3-a7ef-b6c93b1ae6d612026-04-20

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSNdbd1d178-77a3-46ff-985d-307dffaed1ad1
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCDdbd1d178-77a3-46ff-985d-307dffaed1ad1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-4079-36878840790330 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-4079-3) 2026-02-17NoNoHistorical
68788-4079-66878840790660 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-4079-6) 2026-02-17NoNoHistorical
68788-4079-96878840790990 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-4079-9) 2026-02-17NoNoHistorical