FDA.reportPublic FDA data

divalproex sodium

Product NDC
55111-529
11-digit product format
551110529
Labeler code
55111
Product ID
55111-529_be502229-0e61-8481-dda9-794c93637dd7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
divalproex sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Dr.Reddy's Laboratories Limited
Application
ANDA078755
Marketing category
ANDA
Marketing start
2008-07-29
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
Rxcui1099625, 1099678, 1099870

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b10a892b-b985-4cbc-9547-9ac4b72b784fProduct name220250818
7a3a03f1-382a-f9ec-0741-ff24dcbfed69Product name720250624
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
55111-529-01divalproex sodium100 in 1 BOTTLETABLET, DELAYED RELEASE1004
55111-529-05divalproex sodium500 in 1 BOTTLETABLET, DELAYED RELEASE5004
55111-529-30divalproex sodium30 in 1 BOTTLETABLET, DELAYED RELEASE304
55111-529-78divalproex sodium10 in 1 CARTONTABLET, DELAYED RELEASE104
55111-529-79divalproex sodium10 in 1 BLISTER PACKTABLET, DELAYED RELEASE104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-529DIVALPROEX SODIUM TABLET, DELAYED RELEASE [DR.REDDY'S LABORATORIES LIMITED]4Current NDC, Legacy NDC, 5 package rows20190312_15f8a5be-e269-2e07-60d9-1dd7bf5f5281.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099625divalproex sodium 125 MG Delayed Release Oral TabletPSN15f8a5be-e269-2e07-60d9-1dd7bf5f52814
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSN15f8a5be-e269-2e07-60d9-1dd7bf5f52814
1099870divalproex sodium 500 MG Delayed Release Oral TabletPSN15f8a5be-e269-2e07-60d9-1dd7bf5f52814
1099625divalproex sodium 125 MG Delayed Release Oral TabletSCD15f8a5be-e269-2e07-60d9-1dd7bf5f52814
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCD15f8a5be-e269-2e07-60d9-1dd7bf5f52814
1099870divalproex sodium 500 MG Delayed Release Oral TabletSCD15f8a5be-e269-2e07-60d9-1dd7bf5f52814

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-529-0155111052901100 TABLET, DELAYED RELEASE in 1 BOTTLE (55111-529-01) 2008-07-290000-00-00NoNoCurrent
55111-529-0555111052905500 TABLET, DELAYED RELEASE in 1 BOTTLE (55111-529-05) 2008-07-290000-00-00NoNoCurrent
55111-529-305511105293030 TABLET, DELAYED RELEASE in 1 BOTTLE (55111-529-30) 2008-07-290000-00-00NoNoCurrent
55111-529-785511105297810 BLISTER PACK in 1 CARTON (55111-529-78) / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK (55111-529-79) 10 blister pack2008-07-290000-00-00NoNoCurrent
55111-529-795511105297910 in 1 BLISTER PACKHistorical