Divalproex Sodium

Product NDC
68788-8609
11-digit product format
687888609
Labeler code
68788
Product ID
68788-8609_9b32cb32-87e3-43dc-ae3b-cc7f5296310d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA078597
Marketing category
ANDA
Marketing start
2025-03-28
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
68788-8609-3Divalproex Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE302
68788-8609-6Divalproex Sodium60 in 1 BOTTLETABLET, DELAYED RELEASE602
68788-8609-9Divalproex Sodium90 in 1 BOTTLETABLET, DELAYED RELEASE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8609-3EA - Each68788-8609d2895e28-1597-4902-b3e2-44c4d18571ac12025-05-14
68788-8609-6EA - Each68788-8609236f8f85-d73c-44b8-86a7-d59a09afb69d12025-05-14
68788-8609-9EA - Each68788-8609ca1e622b-80d5-48c1-8cda-6517bc742c7112025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8609DIVALPROEX SODIUM TABLET, DELAYED RELEASE [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 3 package rows20250331_d1d4d790-73d5-4a3b-a786-99f2c9812546.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSNd1d4d790-73d5-4a3b-a786-99f2c98125462
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCDd1d4d790-73d5-4a3b-a786-99f2c98125462

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8609-36878886090330 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8609-3) 2025-03-28NoNoHistorical
68788-8609-66878886090660 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8609-6) 2025-03-28NoNoHistorical
68788-8609-96878886090990 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8609-9) 2025-03-28NoNoHistorical