FDA.reportPublic FDA data

divalproex sodium

Product NDC
70756-447
11-digit product format
707560447
Labeler code
70756
Product ID
70756-447_7cdbbe7f-37c2-41c5-87c1-93882fa42865
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
divalproex sodium
Dosage form
CAPSULE, COATED PELLETS
Route
ORAL
Labeler
Lifestar Pharma LLC
Application
ANDA217358
Marketing category
ANDA
Marketing start
2025-08-12
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
70756-447-11divalproex sodium100 in 1 BOTTLECAPSULE, COATED PELLETS1006
70756-447-12divalproex sodium1000 in 1 BOTTLECAPSULE, COATED PELLETS10006
70756-447-30divalproex sodium30 in 1 BOTTLECAPSULE, COATED PELLETS306
70756-447-51divalproex sodium500 in 1 BOTTLECAPSULE, COATED PELLETS5006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099596divalproex sodium 125 MG Delayed Release Oral CapsulePSNb2388bfd-7455-48ae-b396-463df0c278f06
1099596divalproex sodium 125 MG Delayed Release Oral CapsuleSCDb2388bfd-7455-48ae-b396-463df0c278f06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70756-447-1170756044711100 CAPSULE, COATED PELLETS in 1 BOTTLE (70756-447-11) 2025-08-12NoNoCurrent
70756-447-12707560447121000 CAPSULE, COATED PELLETS in 1 BOTTLE (70756-447-12) 2025-08-12NoNoCurrent
70756-447-307075604473030 CAPSULE, COATED PELLETS in 1 BOTTLE (70756-447-30) 2025-08-12NoNoCurrent
70756-447-5170756044751500 CAPSULE, COATED PELLETS in 1 BOTTLE (70756-447-51) 2025-08-12NoNoCurrent