FDA.reportPublic FDA data

Depakote

Product NDC
0074-3826
11-digit product format
000743826
Labeler code
0074
Product ID
0074-3826_700d612c-c97c-48e2-8183-91cc42b9069e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex Sodium
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
AbbVie Inc.
Application
NDA021168
Marketing category
NDA
Marketing start
2000-08-04
Marketing end
2024-06-21
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
0000-00-00
Current FDA listing
Historical FDA.report record

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
0074-3826-11DepakoteER10 in 1 BLISTER PACKTABLET, EXTENDED RELEASE101658
0074-3826-11DepakoteER10 in 1 CARTONTABLET, EXTENDED RELEASE101658
0074-3826-13DepakoteER100 in 1 BOTTLETABLET, EXTENDED RELEASE1001658

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0074-3826-11EA - Each0074-3826e54b1283-8b32-4b0e-81d4-cbd37e6b13a512012-07-24
0074-3826-13EA - Each0074-3826045fad19-25fe-4b04-9b43-8f279dcda03712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIVALPROEX SODIUMACTIVE INGREDIENT644VL95AO6DEPAKOTE ER (DIVALPROEX SODIUM) TABLET, EXTENDED RELEASE [ABBVIE INC.]1571
VALPROIC ACIDACTIVE MOIETY614OI1Z5WIDEPAKOTE ER (DIVALPROEX SODIUM) TABLET, EXTENDED RELEASE [ABBVIE INC.]1571
DIVALPROEX SODIUMACTIVE INGREDIENT644VL95AO6DEPAKOTE (DIVALPROEX SODIUM) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
DIVALPROEX SODIUMACTIVE INGREDIENT644VL95AO6DEPAKOTE (DIVALPROEX SODIUM) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
VALPROIC ACIDACTIVE MOIETY614OI1Z5WIDEPAKOTE (DIVALPROEX SODIUM) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
VALPROIC ACIDACTIVE MOIETY614OI1Z5WIDEPAKOTE (DIVALPROEX SODIUM) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GDEPAKOTE (DIVALPROEX SODIUM) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GDEPAKOTE (DIVALPROEX SODIUM) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ADEPAKOTE (DIVALPROEX SODIUM) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ADEPAKOTE (DIVALPROEX SODIUM) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4DEPAKOTE (DIVALPROEX SODIUM) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4DEPAKOTE (DIVALPROEX SODIUM) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DEPAKOTE (DIVALPROEX SODIUM) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DEPAKOTE (DIVALPROEX SODIUM) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DEPAKOTE (DIVALPROEX SODIUM) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DEPAKOTE (DIVALPROEX SODIUM) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDEPAKOTE (DIVALPROEX SODIUM) TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDEPAKOTE (DIVALPROEX SODIUM) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0074-3826DEPAKOTE ER (DIVALPROEX SODIUM) TABLET, EXTENDED RELEASE [ABBVIE INC.]1655Legacy NDC, 3 package rows20250516_0dc024ce-efc8-4690-7cb5-639c728fccac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099565Depakote ER 250 MG 24HR Extended Release Oral TabletPSN0dc024ce-efc8-4690-7cb5-639c728fccac1658
1099571Depakote ER 500 MG 24HR Extended Release Oral TabletPSN0dc024ce-efc8-4690-7cb5-639c728fccac1658
1099563divalproex sodium 250 MG 24HR Extended Release Oral TabletPSN0dc024ce-efc8-4690-7cb5-639c728fccac1658
1099569divalproex sodium 500 MG 24HR Extended Release Oral TabletPSN0dc024ce-efc8-4690-7cb5-639c728fccac1658
109956524 HR divalproex sodium 250 MG Extended Release Oral Tablet [Depakote]SBD0dc024ce-efc8-4690-7cb5-639c728fccac1658
109957124 HR divalproex sodium 500 MG Extended Release Oral Tablet [Depakote]SBD0dc024ce-efc8-4690-7cb5-639c728fccac1658
109956324 HR divalproex sodium 250 MG Extended Release Oral TabletSCD0dc024ce-efc8-4690-7cb5-639c728fccac1658
109956924 HR divalproex sodium 500 MG Extended Release Oral TabletSCD0dc024ce-efc8-4690-7cb5-639c728fccac1658
109956524 HR Depakote 250 MG Extended Release Oral TabletSY0dc024ce-efc8-4690-7cb5-639c728fccac1658
109957124 HR Depakote 500 MG Extended Release Oral TabletSY0dc024ce-efc8-4690-7cb5-639c728fccac1658
1099565Depakote 250 MG 24 HR Extended Release Oral TabletSY0dc024ce-efc8-4690-7cb5-639c728fccac1658
1099571Depakote 500 MG 24 HR Extended Release Oral TabletSY0dc024ce-efc8-4690-7cb5-639c728fccac1658
1099563divalproex sodium 250 MG 24 HR Extended Release Oral TabletSY0dc024ce-efc8-4690-7cb5-639c728fccac1658
1099569divalproex sodium 500 MG 24 HR Extended Release Oral TabletSY0dc024ce-efc8-4690-7cb5-639c728fccac1658
1099565Depakote ER 250 MG 24HR Extended Release Oral TabletPSNded64147-7a43-4055-accc-2c011828079d1
1099565Depakote ER 250 MG 24HR Extended Release Oral TabletPSNbfbc2cfb-8e96-4cf2-81c7-d63a1b7365c41
1099571Depakote ER 500 MG 24HR Extended Release Oral TabletPSNbfbc2cfb-8e96-4cf2-81c7-d63a1b7365c41
1099571Depakote ER 500 MG 24HR Extended Release Oral TabletPSNded64147-7a43-4055-accc-2c011828079d1
1099563divalproex sodium 250 MG 24HR Extended Release Oral TabletPSNded64147-7a43-4055-accc-2c011828079d1
1099563divalproex sodium 250 MG 24HR Extended Release Oral TabletPSNbfbc2cfb-8e96-4cf2-81c7-d63a1b7365c41
1099569divalproex sodium 500 MG 24HR Extended Release Oral TabletPSNded64147-7a43-4055-accc-2c011828079d1
1099569divalproex sodium 500 MG 24HR Extended Release Oral TabletPSNbfbc2cfb-8e96-4cf2-81c7-d63a1b7365c41
109956524 HR divalproex sodium 250 MG Extended Release Oral Tablet [Depakote]SBDded64147-7a43-4055-accc-2c011828079d1
109956524 HR divalproex sodium 250 MG Extended Release Oral Tablet [Depakote]SBDbfbc2cfb-8e96-4cf2-81c7-d63a1b7365c41
109957124 HR divalproex sodium 500 MG Extended Release Oral Tablet [Depakote]SBDded64147-7a43-4055-accc-2c011828079d1
109957124 HR divalproex sodium 500 MG Extended Release Oral Tablet [Depakote]SBDbfbc2cfb-8e96-4cf2-81c7-d63a1b7365c41
109956324 HR divalproex sodium 250 MG Extended Release Oral TabletSCDbfbc2cfb-8e96-4cf2-81c7-d63a1b7365c41
109956324 HR divalproex sodium 250 MG Extended Release Oral TabletSCDded64147-7a43-4055-accc-2c011828079d1
109956924 HR divalproex sodium 500 MG Extended Release Oral TabletSCDded64147-7a43-4055-accc-2c011828079d1
109956924 HR divalproex sodium 500 MG Extended Release Oral TabletSCDbfbc2cfb-8e96-4cf2-81c7-d63a1b7365c41
109956524 HR Depakote 250 MG Extended Release Oral TabletSYded64147-7a43-4055-accc-2c011828079d1
109956524 HR Depakote 250 MG Extended Release Oral TabletSYbfbc2cfb-8e96-4cf2-81c7-d63a1b7365c41
109957124 HR Depakote 500 MG Extended Release Oral TabletSYded64147-7a43-4055-accc-2c011828079d1
109957124 HR Depakote 500 MG Extended Release Oral TabletSYbfbc2cfb-8e96-4cf2-81c7-d63a1b7365c41
1099565Depakote 250 MG 24 HR Extended Release Oral TabletSYbfbc2cfb-8e96-4cf2-81c7-d63a1b7365c41
1099565Depakote 250 MG 24 HR Extended Release Oral TabletSYded64147-7a43-4055-accc-2c011828079d1
1099571Depakote 500 MG 24 HR Extended Release Oral TabletSYded64147-7a43-4055-accc-2c011828079d1
1099571Depakote 500 MG 24 HR Extended Release Oral TabletSYbfbc2cfb-8e96-4cf2-81c7-d63a1b7365c41
1099563divalproex sodium 250 MG 24 HR Extended Release Oral TabletSYded64147-7a43-4055-accc-2c011828079d1
1099563divalproex sodium 250 MG 24 HR Extended Release Oral TabletSYbfbc2cfb-8e96-4cf2-81c7-d63a1b7365c41
1099569divalproex sodium 500 MG 24 HR Extended Release Oral TabletSYded64147-7a43-4055-accc-2c011828079d1
1099569divalproex sodium 500 MG 24 HR Extended Release Oral TabletSYbfbc2cfb-8e96-4cf2-81c7-d63a1b7365c41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0074-3826-110007438261110 BLISTER PACK in 1 CARTON (0074-3826-11) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK10 blister pack2000-08-040000-00-00NoNoCurrent
0074-3826-1300074382613100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0074-3826-13) 2000-08-040000-00-00NoNoCurrent