Divalproex sodium

Product NDC
70518-1781
11-digit product format
705181781
Labeler code
70518
Product ID
70518-1781_525428a3-f546-ab78-e063-6294a90ad51c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex sodium
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA202419
Marketing category
ANDA
Marketing start
2019-01-07
Substance
DIVALPROEX SODIUM
Active strength
250 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 SODIUM250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii644VL95AO6
Rxcui1099563

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
70518-1781-0Divalproex sodium30 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE3018
70518-1781-1Divalproex sodium100 in 1 BOXTABLET, FILM COATED, EXTENDED RE10018
70518-1781-2Divalproex sodium1 in 1 POUCHTABLET, FILM COATED, EXTENDED RE118

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1781DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [REMEDYREPACK INC.]13Current NDC, Legacy NDC, 3 package rows20250228_7e96b724-5f5f-43cb-8d8b-adff3e1fc779.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099563divalproex sodium 250 MG 24HR Extended Release Oral TabletPSN7e96b724-5f5f-43cb-8d8b-adff3e1fc77918
109956324 HR divalproex sodium 250 MG Extended Release Oral TabletSCD7e96b724-5f5f-43cb-8d8b-adff3e1fc77918
1099563divalproex sodium 250 MG 24 HR Extended Release Oral TabletSY7e96b724-5f5f-43cb-8d8b-adff3e1fc77918

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-1781-07051817810030 in 1 BLISTER PACKHistorical
70518-1781-170518178101100 POUCH in 1 BOX (70518-1781-1) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 POUCH (70518-1781-2) 100 pouch2020-08-030000-00-00NoNoCurrent
70518-1781-2705181781021 in 1 POUCHHistorical