divalproex sodium

Product NDC
70518-4557
11-digit product format
705184557
Labeler code
70518
Product ID
70518-4557_49646ced-d52b-dab7-e063-6294a90aba3f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
divalproex sodium
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA214643
Marketing category
ANDA
Marketing start
2026-01-27
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
70518-4557-0divalproex sodium30 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099563divalproex sodium 250 MG 24HR Extended Release Oral TabletPSN93d6ddb5-7143-4917-baf7-31cbf8a90e8d1
109956324 HR divalproex sodium 250 MG Extended Release Oral TabletSCD93d6ddb5-7143-4917-baf7-31cbf8a90e8d1
1099563divalproex sodium 250 MG 24 HR Extended Release Oral TabletSY93d6ddb5-7143-4917-baf7-31cbf8a90e8d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-4557-07051845570030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (70518-4557-0) 2026-01-27NoNoHistorical