FDA.reportPublic FDA data

Divalproex Sodium

Product NDC
70518-2674
11-digit product format
705182674
Labeler code
70518
Product ID
70518-2674_50b139ad-5e0f-f3ab-e063-6294a90ad6e6
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
2020-04-06
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
70518-2674-0Divalproex Sodium100 in 1 BOXTABLET, DELAYED RELEASE10015
70518-2674-1Divalproex Sodium1 in 1 POUCHTABLET, DELAYED RELEASE115
70518-2674-2Divalproex Sodium30 in 1 BLISTER PACKTABLET, DELAYED RELEASE3015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2674DIVALPROEX SODIUM TABLET, DELAYED RELEASE [REMEDYREPACK INC.]10Current NDC, Legacy NDC, 3 package rows20250327_ed24bb3a-bba1-4b27-8733-96619793fc15.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099870divalproex sodium 500 MG Delayed Release Oral TabletPSNed24bb3a-bba1-4b27-8733-96619793fc1515
1099870divalproex sodium 500 MG Delayed Release Oral TabletSCDed24bb3a-bba1-4b27-8733-96619793fc1515

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2674-070518267400100 POUCH in 1 BOX (70518-2674-0) / 1 TABLET, DELAYED RELEASE in 1 POUCH (70518-2674-1) 100 pouch2020-04-060000-00-00NoNoCurrent
70518-2674-1705182674011 in 1 POUCHHistorical
70518-2674-27051826740230 TABLET, DELAYED RELEASE in 1 BLISTER PACK (70518-2674-2) 2021-04-300000-00-00NoNoCurrent