FDA.reportPublic FDA data

Divalproex sodium

Product NDC
55111-532
11-digit product format
551110532
Labeler code
55111
Product ID
55111-532_a886188f-930f-fcf2-d361-a2a608f95154
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex sodium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Dr. Reddy's Laboratories Ltd
Application
ANDA078979
Marketing category
ANDA
Marketing start
2009-01-23
Substance
DIVALPROEX SODIUM
Active strength
125 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 SODIUM125 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii644VL95AO6
Rxcui1099596

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
55111-532-01Divalproex sodium100 in 1 BOTTLECAPSULE, DELAYED RELEASE10031
55111-532-05Divalproex sodium500 in 1 BOTTLECAPSULE, DELAYED RELEASE50031
55111-532-30Divalproex sodium30 in 1 BOTTLECAPSULE, DELAYED RELEASE3031
55111-532-78Divalproex sodium10 in 1 CARTONCAPSULE, DELAYED RELEASE1031
55111-532-79Divalproex sodium10 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE1031

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-532DIVALPROEX SODIUM CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LTD]29Current NDC, Legacy NDC, 5 package rows20250504_f911748c-fb3a-fe1a-ab2a-4b40455e05ef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099596divalproex sodium 125 MG Delayed Release Oral CapsulePSNf911748c-fb3a-fe1a-ab2a-4b40455e05ef31
1099596divalproex sodium 125 MG Delayed Release Oral CapsuleSCDf911748c-fb3a-fe1a-ab2a-4b40455e05ef31
1099596divalproex sodium 125 MG Delayed Release Oral CapsulePSN388fd4bc-f12f-4e55-a1e7-72aa585519fa28
1099596divalproex sodium 125 MG Delayed Release Oral CapsuleSCD388fd4bc-f12f-4e55-a1e7-72aa585519fa28
1099596divalproex sodium 125 MG Delayed Release Oral CapsulePSN4a0fa934-ec8c-460e-86eb-11281728fe8512
1099596divalproex sodium 125 MG Delayed Release Oral CapsuleSCD4a0fa934-ec8c-460e-86eb-11281728fe8512

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-532-0155111053201100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-532-01) 2009-01-230000-00-00NoNoCurrent
55111-532-0555111053205500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-532-05) 2009-01-230000-00-00NoNoCurrent
55111-532-305511105323030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-532-30) 2009-01-230000-00-00NoNoCurrent
55111-532-785511105327810 BLISTER PACK in 1 CARTON (55111-532-78) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (55111-532-79) 10 blister pack2009-01-230000-00-00NoNoCurrent
55111-532-795511105327910 in 1 BLISTER PACKHistorical