FDA.reportPublic FDA data

Divalproex Sodium

Product NDC
50090-1123
11-digit product format
500901123
Labeler code
50090
Product ID
50090-1123_063cd81a-e948-4ed6-aa2a-9cfeeacf0f57
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078597
Marketing category
ANDA
Marketing start
2008-07-29
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Divalproex Sodium
Listing expiration
2026-12-31

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
50090-1123-0Divalproex Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE302
50090-1123-1Divalproex Sodium100 in 1 BOTTLETABLET, DELAYED RELEASE1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1123-0EA - Each50090-1123831831fa-3859-4d47-ab1d-5bc871728ff012024-12-10
50090-1123-1EA - Each50090-1123cf2247cf-5474-4f30-81b2-a18390c3aa0512024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1123DIVALPROEX SODIUM TABLET, DELAYED RELEASE [A-S MEDICATION SOLUTIONS]2Current NDC, 2 package rows20241108_c8f72850-92d5-4f64-b9f1-657f72bfa15a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSNc8f72850-92d5-4f64-b9f1-657f72bfa15a2
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCDc8f72850-92d5-4f64-b9f1-657f72bfa15a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-1123-05009011230030 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-1123-0) 2014-11-28NoNoCurrent
50090-1123-150090112301100 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-1123-1) 2024-10-24NoNoCurrent