FDA.reportPublic FDA data

Divalproex sodium

Product NDC
71610-289
11-digit product format
716100289
Labeler code
71610
Product ID
71610-289_214cf544-a872-5727-e063-6294a90a5843
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
71610-289-30Divalproex sodium30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE302
71610-289-60Divalproex sodium90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE902
71610-289-75Divalproex sodium150 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1502
71610-289-80Divalproex sodium180 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1802
71610-289-92Divalproex sodium270 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE2702

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-289-30EA - Each71610-289f58660ec-f662-4d9b-b1ce-f58bd185503012019-07-02
71610-289-60EA - Each71610-289c3724e3b-c078-43e6-8c13-c85c27e589a012019-07-02
71610-289-75EA - Each71610-2897910d5c5-cba3-4e48-ba48-05e4b938669512019-07-02
71610-289-80EA - Each71610-289d92eb8b2-b7ee-4c39-a7c3-dd2acaa1103c12024-12-10
71610-289-92EA - Each71610-2890d32dba9-4a72-43c4-a4e1-28b69c6351dd12024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-289DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, Legacy NDC, 5 package rows20240906_9a9f5f24-e421-406f-ac91-d1f964245f54.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099563divalproex sodium 250 MG 24HR Extended Release Oral TabletPSN9a9f5f24-e421-406f-ac91-d1f964245f542
109956324 HR divalproex sodium 250 MG Extended Release Oral TabletSCD9a9f5f24-e421-406f-ac91-d1f964245f542
1099563divalproex sodium 250 MG 24 HR Extended Release Oral TabletSY9a9f5f24-e421-406f-ac91-d1f964245f542

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-289-307161002893030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-289-30) 2019-06-050000-00-00NoNoCurrent
71610-289-607161002896090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-289-60) 2019-06-050000-00-00NoNoCurrent
71610-289-7571610028975150 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-289-75) 2019-06-050000-00-00NoNoCurrent
71610-289-8071610028980180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-289-80) 2024-09-03NoNoHistorical
71610-289-9271610028992270 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-289-92) 2024-09-03NoNoHistorical