Divalproex Sodium

Product NDC
70518-1558
11-digit product format
705181558
Labeler code
70518
Product ID
70518-1558_50ae5444-7b3c-9a54-e063-6294a90a1ab1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA078597
Marketing category
ANDA
Marketing start
2018-10-19
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
Rxcui1099870

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
70518-1558-0Divalproex Sodium30 in 1 BLISTER PACKTABLET, DELAYED RELEASE3017
70518-1558-1Divalproex Sodium100 in 1 BOXTABLET, DELAYED RELEASE10017
70518-1558-2Divalproex Sodium1 in 1 POUCHTABLET, DELAYED RELEASE117

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1558DIVALPROEX SODIUM TABLET, DELAYED RELEASE [REMEDYREPACK INC.]13Current NDC, Legacy NDC, 3 package rows20250226_cf15569c-5010-4e9b-aef0-7df4de5ed04e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099870divalproex sodium 500 MG Delayed Release Oral TabletPSNcf15569c-5010-4e9b-aef0-7df4de5ed04e17
1099870divalproex sodium 500 MG Delayed Release Oral TabletSCDcf15569c-5010-4e9b-aef0-7df4de5ed04e17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-1558-07051815580030 TABLET, DELAYED RELEASE in 1 BLISTER PACK (70518-1558-0) 2018-10-190000-00-00NoNoCurrent
70518-1558-170518155801100 POUCH in 1 BOX (70518-1558-1) / 1 TABLET, DELAYED RELEASE in 1 POUCH (70518-1558-2) 100 pouch2019-10-160000-00-00NoNoCurrent
70518-1558-2705181558021 in 1 POUCHHistorical