FDA.reportPublic FDA data

Divalproex sodium

Product NDC
71610-157
11-digit product format
716100157
Labeler code
71610
Product ID
71610-157_33511714-8ded-46ee-ae1d-03a536728d31
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Divalproex sodium
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA202419
Marketing category
ANDA
Marketing start
2014-06-02
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Divalproex sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIVALPROEX SODIUM250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii644VL95AO6
Rxcui1099563

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
71610-157-60Divalproex sodium90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE901
71610-157-75Divalproex sodium150 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1501

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-157-60EA - Each71610-15794c2818c-5f0c-4535-bbc9-60fe9ff6990e12020-06-05
71610-157-75EA - Each71610-1574ab8ad66-e76b-4a13-8859-372991ebbcd612020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-157DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 2 package rows20181017_ad5e8bd8-c923-40f0-a106-55620c4247d7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099563divalproex sodium 250 MG 24HR Extended Release Oral TabletPSNad5e8bd8-c923-40f0-a106-55620c4247d71
109956324 HR divalproex sodium 250 MG Extended Release Oral TabletSCDad5e8bd8-c923-40f0-a106-55620c4247d71
1099563divalproex sodium 250 MG 24 HR Extended Release Oral TabletSYad5e8bd8-c923-40f0-a106-55620c4247d71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-157-607161001576090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-157-60) 2018-09-200000-00-00NoNoCurrent
71610-157-7571610015775150 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-157-75) 2018-09-200000-00-00NoNoCurrent