FDA.reportPublic FDA data

Divalproex Sodium

Product NDC
71335-0008
11-digit product format
713350008
Labeler code
71335
Product ID
71335-0008_3cc98db5-a0e2-48ee-bd51-86dddc1c8c5b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA079163
Marketing category
ANDA
Marketing start
2011-10-01
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
71335-0008-1Divalproex Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE3010
71335-0008-2Divalproex Sodium60 in 1 BOTTLETABLET, DELAYED RELEASE6010
71335-0008-3Divalproex Sodium90 in 1 BOTTLETABLET, DELAYED RELEASE9010
71335-0008-4Divalproex Sodium120 in 1 BOTTLETABLET, DELAYED RELEASE12010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0008-1EA - Each71335-00088570b99b-16e5-452a-b935-e3300ee1536512018-03-08
71335-0008-2EA - Each71335-000819dd47a4-4340-41e4-80b4-ae563f36f35412018-03-08
71335-0008-3EA - Each71335-00083f4a59b5-68ca-4c65-b32a-b745a109eff712018-03-08
71335-0008-4EA - Each71335-0008a352d7b9-548a-442c-bf0e-aa09592b839c12018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0008DIVALPROEX SODIUM TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK]9Current NDC, Legacy NDC, 4 package rows20250331_d67af03a-5261-4358-8787-2e729267ff7e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSNd67af03a-5261-4358-8787-2e729267ff7e10
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCDd67af03a-5261-4358-8787-2e729267ff7e10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0008-17133500080130 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0008-1) 2018-12-210000-00-00NoNoCurrent
71335-0008-27133500080260 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0008-2) 2018-03-060000-00-00NoNoCurrent
71335-0008-37133500080390 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0008-3) 2018-03-010000-00-00NoNoCurrent
71335-0008-471335000804120 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0008-4) 2021-12-270000-00-00NoNoCurrent