FDA.reportPublic FDA data

Divalproex Sodium

Product NDC
63629-4278
11-digit product format
636294278
Labeler code
63629
Product ID
63629-4278_eabfb39a-225d-4b2f-b9ac-0751f0ea5cbb
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
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
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
63629-4278-1Divalproex Sodium60 in 1 BOTTLETABLET, DELAYED RELEASE601014
63629-4278-2Divalproex Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE301014
63629-4278-3Divalproex Sodium90 in 1 BOTTLETABLET, DELAYED RELEASE901014
63629-4278-4Divalproex Sodium180 in 1 BOTTLETABLET, DELAYED RELEASE1801014
63629-4278-5Divalproex Sodium120 in 1 BOTTLETABLET, DELAYED RELEASE1201014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-4278-1EA - Each63629-427862a622eb-aede-4fda-a8bc-58353e585fd212012-07-24
63629-4278-2EA - Each63629-42782c974f85-421a-4005-8470-1062c7c8f31112012-07-24
63629-4278-3EA - Each63629-42783fc443a6-efbb-4a98-b040-889d7684562112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIVALPROEX SODIUMACTIVE INGREDIENT644VL95AO6DIVALPROEX SODIUM TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK]1005
VALPROIC ACIDACTIVE MOIETY614OI1Z5WIDIVALPROEX SODIUM TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK]1005
ALCOHOLINACTIVE INGREDIENT3K9958V90MDIVALPROEX SODIUM TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK]1005
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3DIVALPROEX SODIUM TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK]1005
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIVALPROEX SODIUM TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK]1005
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DIVALPROEX SODIUM TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK]1005
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDIVALPROEX SODIUM TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK]1005
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DIVALPROEX SODIUM TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK]1005
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6DIVALPROEX SODIUM TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK]1005
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302DIVALPROEX SODIUM TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK]1005
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDIVALPROEX SODIUM TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK]1005
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JDIVALPROEX SODIUM TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK]1005
POLYETHYLENE GLYCOL 3000INACTIVE INGREDIENTSA1B764746DIVALPROEX SODIUM TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK]1005
POVIDONE K29/32INACTIVE INGREDIENT390RMW2PEQDIVALPROEX SODIUM TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK]1005
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DIVALPROEX SODIUM TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK]1005
SHELLACINACTIVE INGREDIENT46N107B71ODIVALPROEX SODIUM TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK]1005
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIVALPROEX SODIUM TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK]1005
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QODIVALPROEX SODIUM TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK]1005
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDIVALPROEX SODIUM TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK]1005
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDIVALPROEX SODIUM TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK]1005
TALCINACTIVE INGREDIENT7SEV7J4R1UDIVALPROEX SODIUM TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK]1005
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDIVALPROEX SODIUM TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK]1005
TRIACETININACTIVE INGREDIENTXHX3C3X673DIVALPROEX SODIUM TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK]1005
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMDIVALPROEX SODIUM TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK]1005
VANILLININACTIVE INGREDIENTCHI530446XDIVALPROEX SODIUM TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK]1005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-4278DIVALPROEX SODIUM TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK]1014Current NDC, Legacy NDC, 5 package rows20250327_c8d9cd69-ceca-3057-9d1c-12c44b19f767.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099870divalproex sodium 500 MG Delayed Release Oral TabletPSNc8d9cd69-ceca-3057-9d1c-12c44b19f7671014
1099870divalproex sodium 500 MG Delayed Release Oral TabletSCDc8d9cd69-ceca-3057-9d1c-12c44b19f7671014

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-4278-16362942780160 TABLET, DELAYED RELEASE in 1 BOTTLE (63629-4278-1) 2021-12-220000-00-00NoNoCurrent
63629-4278-26362942780230 TABLET, DELAYED RELEASE in 1 BOTTLE (63629-4278-2) 2012-11-190000-00-00NoNoCurrent
63629-4278-36362942780390 TABLET, DELAYED RELEASE in 1 BOTTLE (63629-4278-3) 2014-11-100000-00-00NoNoCurrent
63629-4278-463629427804180 TABLET, DELAYED RELEASE in 1 BOTTLE (63629-4278-4) 2018-05-310000-00-00NoNoCurrent
63629-4278-563629427805120 TABLET, DELAYED RELEASE in 1 BOTTLE (63629-4278-5) 2018-09-170000-00-00NoNoCurrent