FDA.reportPublic FDA data

Depakote

Product NDC
0074-7325
11-digit product format
000747325
Labeler code
0074
Product ID
0074-7325_7cc3a0b3-93f8-4825-88e1-bf6ddb0db23d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
AbbVie Inc.
Application
NDA018723
Marketing category
NDA
Marketing start
1983-03-10
Substance
DIVALPROEX SODIUM
Active strength
125 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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIVALPROEX SODIUM125 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii644VL95AO6
Rxcui1099625, 1099626, 1099678, 1099679, 1099870, 1099871

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b10a892b-b985-4cbc-9547-9ac4b72b784fProduct name220250818
7a3a03f1-382a-f9ec-0741-ff24dcbfed69Product name720250624
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
0074-7325-13Depakote100 in 1 BOTTLETABLET, DELAYED RELEASE1001621

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0074-7325-13EA - Each0074-7325844051f9-f96e-4b60-b4fc-d40e886ab0dd12022-05-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIVALPROEX SODIUMACTIVE INGREDIENT644VL95AO6DEPAKOTE (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [ABBVIE INC.]1541
VALPROIC ACIDACTIVE MOIETY614OI1Z5WIDEPAKOTE (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [ABBVIE INC.]1541
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BDEPAKOTE (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [ABBVIE INC.]1541
DIACETYLATED MONOGLYCERIDESINACTIVE INGREDIENT5Z17386USFDEPAKOTE (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [ABBVIE INC.]1541
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDEPAKOTE (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [ABBVIE INC.]1541
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDEPAKOTE (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [ABBVIE INC.]1541
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADEPAKOTE (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [ABBVIE INC.]1541
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DEPAKOTE (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [ABBVIE INC.]1541
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DEPAKOTE (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [ABBVIE INC.]1541
POVIDONESINACTIVE INGREDIENTFZ989GH94EDEPAKOTE (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [ABBVIE INC.]1541
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DEPAKOTE (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [ABBVIE INC.]1541
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDEPAKOTE (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [ABBVIE INC.]1541
TALCINACTIVE INGREDIENT7SEV7J4R1UDEPAKOTE (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [ABBVIE INC.]1541
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDEPAKOTE (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [ABBVIE INC.]1541
VANILLININACTIVE INGREDIENTCHI530446XDEPAKOTE (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [ABBVIE INC.]1541

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0074-7325DEPAKOTE (DIVALPROEX SODIUM) TABLET, DELAYED RELEASE [ABBVIE INC.]1618Current NDC, Legacy NDC, 1 package rows20250510_08a65cf4-7749-4ceb-6895-8f4805e2b01f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099626Depakote 125 MG Delayed Release Oral TabletPSN08a65cf4-7749-4ceb-6895-8f4805e2b01f1621
1099679Depakote 250 MG Delayed Release Oral TabletPSN08a65cf4-7749-4ceb-6895-8f4805e2b01f1621
1099871Depakote 500 MG Delayed Release Oral TabletPSN08a65cf4-7749-4ceb-6895-8f4805e2b01f1621
1099625divalproex sodium 125 MG Delayed Release Oral TabletPSN08a65cf4-7749-4ceb-6895-8f4805e2b01f1621
1099678divalproex sodium 250 MG Delayed Release Oral TabletPSN08a65cf4-7749-4ceb-6895-8f4805e2b01f1621
1099870divalproex sodium 500 MG Delayed Release Oral TabletPSN08a65cf4-7749-4ceb-6895-8f4805e2b01f1621
1099626divalproex sodium 125 MG Delayed Release Oral Tablet [Depakote]SBD08a65cf4-7749-4ceb-6895-8f4805e2b01f1621
1099679divalproex sodium 250 MG Delayed Release Oral Tablet [Depakote]SBD08a65cf4-7749-4ceb-6895-8f4805e2b01f1621
1099871divalproex sodium 500 MG Delayed Release Oral Tablet [Depakote]SBD08a65cf4-7749-4ceb-6895-8f4805e2b01f1621
1099625divalproex sodium 125 MG Delayed Release Oral TabletSCD08a65cf4-7749-4ceb-6895-8f4805e2b01f1621
1099678divalproex sodium 250 MG Delayed Release Oral TabletSCD08a65cf4-7749-4ceb-6895-8f4805e2b01f1621
1099870divalproex sodium 500 MG Delayed Release Oral TabletSCD08a65cf4-7749-4ceb-6895-8f4805e2b01f1621
1099626Depakote 125 MG Delayed Release Oral TabletSY08a65cf4-7749-4ceb-6895-8f4805e2b01f1621
1099679Depakote 250 MG Delayed Release Oral TabletSY08a65cf4-7749-4ceb-6895-8f4805e2b01f1621
1099871Depakote 500 MG Delayed Release Oral TabletSY08a65cf4-7749-4ceb-6895-8f4805e2b01f1621

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0074-7325-1300074732513100 TABLET, DELAYED RELEASE in 1 BOTTLE (0074-7325-13) 1983-03-100000-00-00NoNoCurrent