FDA.reportPublic FDA data

Divalproex sodium

Product NDC
70518-3457
11-digit product format
705183457
Labeler code
70518
Product ID
70518-3457_4b7f1cd7-fe8e-b4b6-e063-6394a90a7914
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex sodium
Dosage form
CAPSULE, COATED PELLETS
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA213181
Marketing category
ANDA
Marketing start
2020-07-20
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
Divalproex sodium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIVALPROEX SODIUM125 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii644VL95AO6

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
70518-3457-0Divalproex sodium100 in 1 BOXCAPSULE, COATED PELLETS10010
70518-3457-1Divalproex sodium1 in 1 POUCHCAPSULE, COATED PELLETS110
70518-3457-2Divalproex sodium100 in 1 BOXCAPSULE, COATED PELLETS10010
70518-3457-3Divalproex sodium1 in 1 POUCHCAPSULE, COATED PELLETS110
70518-3457-4Divalproex sodium30 in 1 BLISTER PACKCAPSULE, COATED PELLETS3010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3457DIVALPROEX SODIUM CAPSULE, COATED PELLETS [REMEDYREPACK INC.]8Current NDC, Legacy NDC, 5 package rows20250417_7ead614c-a68d-4a2f-94d0-e6404a8f8760.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3457-070518345700100 POUCH in 1 BOX (70518-3457-0) > 1 CAPSULE, COATED PELLETS in 1 POUCH (70518-3457-1) 100 pouch2022-07-200000-00-00NoNoCurrent
70518-3457-1705183457011 in 1 POUCHHistorical
70518-3457-270518345702100 POUCH in 1 BOX (70518-3457-2) / 1 CAPSULE, COATED PELLETS in 1 POUCH (70518-3457-3) 100 pouch2023-08-01NoNoHistorical
70518-3457-3705183457031 in 1 POUCHHistorical
70518-3457-47051834570430 CAPSULE, COATED PELLETS in 1 BLISTER PACK (70518-3457-4) 2026-02-18NoNoHistorical