FDA.reportPublic FDA data

Divalproex Sodium

Product NDC
71335-2344
11-digit product format
713352344
Labeler code
71335
Product ID
71335-2344_d41d8bda-5623-4398-afb2-2a4a3d6dd0f1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078597
Marketing category
ANDA
Marketing start
2008-07-29
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
Rxcui1099870

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b10a892b-b985-4cbc-9547-9ac4b72b784fProduct name220250818
7a3a03f1-382a-f9ec-0741-ff24dcbfed69Product name720250624
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
57fc3d01-4737-4091-9728-9e8a4c9e708dProduct name120200121
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5d67ecc7-47c7-ec5e-e9eb-71bf00250645Product name120140508
97fce1a8-50c4-f088-0e31-64d82b6e9081Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2344-1Divalproex Sodium60 in 1 BOTTLETABLET, DELAYED RELEASE60102
71335-2344-2Divalproex Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE30102
71335-2344-3Divalproex Sodium90 in 1 BOTTLETABLET, DELAYED RELEASE90102
71335-2344-4Divalproex Sodium180 in 1 BOTTLETABLET, DELAYED RELEASE180102
71335-2344-5Divalproex Sodium120 in 1 BOTTLETABLET, DELAYED RELEASE120102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2344DIVALPROEX SODIUM TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK]102Current NDC, 5 package rows20250402_48a6e47a-3697-492d-9086-56e4ca0151e5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099870divalproex sodium 500 MG Delayed Release Oral TabletPSN48a6e47a-3697-492d-9086-56e4ca0151e5102
1099870divalproex sodium 500 MG Delayed Release Oral TabletSCD48a6e47a-3697-492d-9086-56e4ca0151e5102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2344-17133523440160 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2344-1) 2024-05-30NoNoHistorical
71335-2344-27133523440230 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2344-2) 2024-05-30NoNoHistorical
71335-2344-37133523440390 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2344-3) 2024-01-29NoNoHistorical
71335-2344-471335234404180 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2344-4) 2024-05-30NoNoHistorical
71335-2344-571335234405120 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2344-5) 2024-05-30NoNoHistorical