Divalproex Sodium

Product NDC
70518-3683
11-digit product format
705183683
Labeler code
70518
Product ID
70518-3683_4f7f568a-339b-7011-e063-6394a90a1af5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex Sodium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA090554
Marketing category
ANDA
Marketing start
2023-03-17
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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b10a892b-b985-4cbc-9547-9ac4b72b784fProduct name220250818
7a3a03f1-382a-f9ec-0741-ff24dcbfed69Product name720250624
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
57fc3d01-4737-4091-9728-9e8a4c9e708dProduct name120200121
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5d67ecc7-47c7-ec5e-e9eb-71bf00250645Product name120140508
97fce1a8-50c4-f088-0e31-64d82b6e9081Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3683-0Divalproex Sodium30 in 1 BLISTER PACKTABLET, DELAYED RELEASE309
70518-3683-1Divalproex Sodium30 in 1 BLISTER PACKTABLET, DELAYED RELEASE309
70518-3683-2Divalproex Sodium30 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE309

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3683DIVALPROEX SODIUM TABLET, DELAYED RELEASE [REMEDYREPACK INC.]5Current NDC, 3 package rows20241013_a999f402-be1d-4153-b743-cfdb95ed1562.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099625divalproex sodium 125 MG Delayed Release Oral TabletPSNa999f402-be1d-4153-b743-cfdb95ed15629
1099625divalproex sodium 125 MG Delayed Release Oral TabletSCDa999f402-be1d-4153-b743-cfdb95ed15629

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-3683-07051836830030 TABLET, DELAYED RELEASE in 1 BLISTER PACK (70518-3683-0) 2023-03-17NoNoHistorical
70518-3683-17051836830130 TABLET, DELAYED RELEASE in 1 BLISTER PACK (70518-3683-1) 2023-09-13NoNoHistorical
70518-3683-27051836830230 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-3683-2) 2025-07-01NoNoHistorical