FDA.reportPublic FDA data

Divalproex Sodium

Product NDC
0904-7182
11-digit product format
009047182
Labeler code
0904
Product ID
0904-7182_eb856e10-53b1-45b8-a784-efae752c7cfe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex Sodium
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA203730
Marketing category
ANDA
Marketing start
2015-06-01
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Divalproex Sodium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIVALPROEX SODIUM500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii644VL95AO6
Rxcui1099563, 1099569

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b10a892b-b985-4cbc-9547-9ac4b72b784fProduct name220250818
7a3a03f1-382a-f9ec-0741-ff24dcbfed69Product name720250624
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
0904-7182-45Divalproex Sodium1 in 1 BLISTER PACKTABLET, EXTENDED RELEASE18
0904-7182-45Divalproex Sodium80 in 1 CARTONTABLET, EXTENDED RELEASE808
0904-7182-61Divalproex Sodium100 in 1 CARTONTABLET, EXTENDED RELEASE1008
0904-7182-61Divalproex Sodium1 in 1 BLISTER PACKTABLET, EXTENDED RELEASE18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7182DIVALPROEX SODIUM TABLET, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]5Current NDC, Legacy NDC, 4 package rows20250510_ef472176-7f98-4f88-be5e-a101fecb46fd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099563divalproex sodium 250 MG 24HR Extended Release Oral TabletPSNef472176-7f98-4f88-be5e-a101fecb46fd8
1099569divalproex sodium 500 MG 24HR Extended Release Oral TabletPSNef472176-7f98-4f88-be5e-a101fecb46fd8
109956324 HR divalproex sodium 250 MG Extended Release Oral TabletSCDef472176-7f98-4f88-be5e-a101fecb46fd8
109956924 HR divalproex sodium 500 MG Extended Release Oral TabletSCDef472176-7f98-4f88-be5e-a101fecb46fd8
1099563divalproex sodium 250 MG 24 HR Extended Release Oral TabletSYef472176-7f98-4f88-be5e-a101fecb46fd8
1099569divalproex sodium 500 MG 24 HR Extended Release Oral TabletSYef472176-7f98-4f88-be5e-a101fecb46fd8
1099569divalproex sodium 500 MG 24HR Extended Release Oral TabletPSN283af6d2-8ea2-4225-b2e7-a2057dbdb7936
109956924 HR divalproex sodium 500 MG Extended Release Oral TabletSCD283af6d2-8ea2-4225-b2e7-a2057dbdb7936
1099569divalproex sodium 500 MG 24 HR Extended Release Oral TabletSY283af6d2-8ea2-4225-b2e7-a2057dbdb7936

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-7182-450090471824580 BLISTER PACK in 1 CARTON (0904-7182-45) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK80 blister pack2015-06-010000-00-00NoNoCurrent
0904-7182-6100904718261100 BLISTER PACK in 1 CARTON (0904-7182-61) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK100 blister pack2015-06-010000-00-00NoNoCurrent