FDA.reportPublic FDA data

Divalproex Sodium

Product NDC
55111-534
11-digit product format
551110534
Labeler code
55111
Product ID
55111-534_0d557d96-7ebb-86b3-bdd1-af0b959bc845
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex Sodium
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Dr. Reddy's Laboratories Ltd
Application
ANDA090070
Marketing category
ANDA
Marketing start
2013-08-11
Substance
DIVALPROEX SODIUM
Active strength
500 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 SODIUM500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii644VL95AO6
Rxcui1099569

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
55111-534-01Divalproex Sodium100 in 1 BOTTLETABLET, EXTENDED RELEASE10027
55111-534-05Divalproex Sodium500 in 1 BOTTLETABLET, EXTENDED RELEASE50027
55111-534-30Divalproex Sodium30 in 1 BOTTLETABLET, EXTENDED RELEASE3027
55111-534-60Divalproex Sodium60 in 1 BOTTLETABLET, EXTENDED RELEASE6027

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-534-01EA - Each55111-534bbf7378e-1484-4a1c-85d5-75a02bb3bcc912013-09-04
55111-534-05EA - Each55111-53462acbfdf-88e4-4c06-a1d4-db46a927895312013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
divalproex sodiumACTIVE INGREDIENT644VL95AO6DIVALPROEX SODIUM TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LTD]12
valproic acidACTIVE MOIETY614OI1Z5WIDIVALPROEX SODIUM TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LTD]12
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UDIVALPROEX SODIUM TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LTD]12
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTDIVALPROEX SODIUM TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LTD]12
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357DIVALPROEX SODIUM TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LTD]12
hydroxyethyl cellulose (2000 CPS AT 1%)INACTIVE INGREDIENTS38J6RZN16DIVALPROEX SODIUM TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LTD]12
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PDIVALPROEX SODIUM TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LTD]12
hypromellosesINACTIVE INGREDIENT3NXW29V3WODIVALPROEX SODIUM TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LTD]12
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XDIVALPROEX SODIUM TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LTD]12
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4DIVALPROEX SODIUM TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LTD]12
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPDIVALPROEX SODIUM TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LTD]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-534DIVALPROEX SODIUM TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES LTD]26Current NDC, Legacy NDC, 4 package rows20250504_fa823ee0-0c69-6b85-da1e-9bb2e2150ea5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099569divalproex sodium 500 MG 24HR Extended Release Oral TabletPSNfa823ee0-0c69-6b85-da1e-9bb2e2150ea527
109956924 HR divalproex sodium 500 MG Extended Release Oral TabletSCDfa823ee0-0c69-6b85-da1e-9bb2e2150ea527
1099569divalproex sodium 500 MG 24 HR Extended Release Oral TabletSYfa823ee0-0c69-6b85-da1e-9bb2e2150ea527
1099569divalproex sodium 500 MG 24HR Extended Release Oral TabletPSN5012d24b-3710-458a-9402-661e525649213
109956924 HR divalproex sodium 500 MG Extended Release Oral TabletSCD5012d24b-3710-458a-9402-661e525649213
1099569divalproex sodium 500 MG 24 HR Extended Release Oral TabletSY5012d24b-3710-458a-9402-661e525649213
1099569divalproex sodium 500 MG 24HR Extended Release Oral TabletPSN5a92253f-a665-afe2-e053-2991aa0a90cd1
1099569divalproex sodium 500 MG 24HR Extended Release Oral TabletPSNdc9e4871-fb3d-4c59-81e5-2ab6e8be9b7c1
109956924 HR divalproex sodium 500 MG Extended Release Oral TabletSCD5a92253f-a665-afe2-e053-2991aa0a90cd1
109956924 HR divalproex sodium 500 MG Extended Release Oral TabletSCDdc9e4871-fb3d-4c59-81e5-2ab6e8be9b7c1
1099569divalproex sodium 500 MG 24 HR Extended Release Oral TabletSY5a92253f-a665-afe2-e053-2991aa0a90cd1
1099569divalproex sodium 500 MG 24 HR Extended Release Oral TabletSYdc9e4871-fb3d-4c59-81e5-2ab6e8be9b7c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55111-534-0155111053401100 TABLET, EXTENDED RELEASE in 1 BOTTLE (55111-534-01) 2013-08-110000-00-00NoNoCurrent
55111-534-0555111053405500 TABLET, EXTENDED RELEASE in 1 BOTTLE (55111-534-05) 2013-08-110000-00-00NoNoCurrent
55111-534-305511105343030 TABLET, EXTENDED RELEASE in 1 BOTTLE (55111-534-30) 2013-08-110000-00-00NoNoCurrent
55111-534-605511105346060 TABLET, EXTENDED RELEASE in 1 BOTTLE (55111-534-60) 2013-08-110000-00-00NoNoCurrent