Divalproex sodium

Product NDC
27241-115
11-digit product format
272410115
Labeler code
27241
Product ID
27241-115_d905fd66-055a-4130-8e67-20c0645362f0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex sodium
Dosage form
CAPSULE, COATED PELLETS
Route
ORAL
Labeler
Ajanta Pharma USA Inc.
Application
ANDA213181
Marketing category
ANDA
Marketing start
2020-05-15
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

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
27241-115-01Divalproex sodium100 in 1 BOTTLECAPSULE, COATED PELLETS10013
27241-115-05Divalproex sodium500 in 1 BOTTLECAPSULE, COATED PELLETS50013
27241-115-10Divalproex sodium1000 in 1 BOTTLECAPSULE, COATED PELLETS100013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27241-115DIVALPROEX SODIUM CAPSULE, COATED PELLETS [AJANTA PHARMA USA INC.]11Current NDC, Legacy NDC, 3 package rows20250309_773a289b-65ed-4045-80c5-f00e28c1c079.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099596divalproex sodium 125 MG Delayed Release Oral CapsulePSN773a289b-65ed-4045-80c5-f00e28c1c07914
1099596divalproex sodium 125 MG Delayed Release Oral CapsuleSCD773a289b-65ed-4045-80c5-f00e28c1c07914

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
27241-115-0127241011501100 CAPSULE, COATED PELLETS in 1 BOTTLE (27241-115-01) 2020-05-150000-00-00NoNoCurrent
27241-115-0527241011505500 CAPSULE, COATED PELLETS in 1 BOTTLE (27241-115-05) 2020-05-150000-00-00NoNoCurrent
27241-115-10272410115101000 CAPSULE, COATED PELLETS in 1 BOTTLE (27241-115-10) 2020-05-150000-00-00NoNoCurrent