FDA.reportPublic FDA data

Depakote

Product NDC
0074-7401
11-digit product format
000747401
Labeler code
0074
Product ID
0074-7401_0ee65b66-ead3-44ef-911f-14965b067903
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
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Depakote
Brand name suffix
ER
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIVALPROEX SODIUM250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii644VL95AO6
Rxcui1099563, 1099565, 1099569, 1099571

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
0074-7401-13DepakoteER100 in 1 BOTTLETABLET, EXTENDED RELEASE1001658

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0074-7401-13EA - Each0074-74014edc2a13-b7f4-4bba-b78d-0a73698b83f012022-05-04

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0074-7401DEPAKOTE ER (DIVALPROEX SODIUM) TABLET, EXTENDED RELEASE [ABBVIE INC.]1655Current NDC, Legacy NDC, 1 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0074-7401-1300074740113100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0074-7401-13) 2000-08-040000-00-00NoNoCurrent