divalproex sodium

Product NDC
70518-1749
11-digit product format
705181749
Labeler code
70518
Product ID
70518-1749_50aee7c6-5343-9d1f-e063-6294a90ad72c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
divalproex sodium
Dosage form
CAPSULE, COATED PELLETS
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA078919
Marketing category
ANDA
Marketing start
2018-12-17
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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii644VL95AO6
Rxcui1099596

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
70518-1749-0divalproex sodium1 in 1 POUCHCAPSULE, COATED PELLETS116
70518-1749-1divalproex sodium100 in 1 BOXCAPSULE, COATED PELLETS10016

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1749DIVALPROEX SODIUM CAPSULE, COATED PELLETS [REMEDYREPACK INC.]13Current NDC, Legacy NDC, 2 package rows20250306_ab8616a5-ea72-4df7-b095-54ea19ef6fba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099596divalproex sodium 125 MG Delayed Release Oral CapsulePSNab8616a5-ea72-4df7-b095-54ea19ef6fba16
1099596divalproex sodium 125 MG Delayed Release Oral CapsuleSCDab8616a5-ea72-4df7-b095-54ea19ef6fba16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-1749-0705181749001 in 1 POUCHHistorical
70518-1749-170518174901100 POUCH in 1 BOX (70518-1749-1) / 1 CAPSULE, COATED PELLETS in 1 POUCH (70518-1749-0) 100 pouch2018-12-170000-00-00NoNoCurrent