FDA.reportPublic FDA data

Divalproex Sodium

Product NDC
50268-259
11-digit product format
502680259
Labeler code
50268
Product ID
50268-259_47e34870-0259-c99d-e063-6394a90ae59a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex Sodium
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
AvPAK
Application
ANDA203730
Marketing category
ANDA
Marketing start
2022-09-16
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, 1099569

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
50268-259-11Divalproex Sodium1 in 1 BLISTER PACKTABLET, EXTENDED RELEASE13
50268-259-15Divalproex Sodium50 in 1 BOXTABLET, EXTENDED RELEASE503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-259DIVALPROEX SODIUM TABLET, EXTENDED RELEASE [AVPAK]2Current NDC, Legacy NDC, 2 package rows20240110_e8cc336b-5191-7f8b-e053-2a95a90a6acb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099563divalproex sodium 250 MG 24HR Extended Release Oral TabletPSNe8cc336b-5191-7f8b-e053-2a95a90a6acb3
1099569divalproex sodium 500 MG 24HR Extended Release Oral TabletPSNe8cc336b-5191-7f8b-e053-2a95a90a6acb3
109956324 HR divalproex sodium 250 MG Extended Release Oral TabletSCDe8cc336b-5191-7f8b-e053-2a95a90a6acb3
109956924 HR divalproex sodium 500 MG Extended Release Oral TabletSCDe8cc336b-5191-7f8b-e053-2a95a90a6acb3
1099563divalproex sodium 250 MG 24 HR Extended Release Oral TabletSYe8cc336b-5191-7f8b-e053-2a95a90a6acb3
1099569divalproex sodium 500 MG 24 HR Extended Release Oral TabletSYe8cc336b-5191-7f8b-e053-2a95a90a6acb3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-259-11502680259111 in 1 BLISTER PACKHistorical
50268-259-155026802591550 BLISTER PACK in 1 BOX (50268-259-15) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (50268-259-11) 50 blister pack2022-09-160000-00-00NoNoCurrent