FDA.reportPublic FDA data

Divalproex Sodium

Product NDC
71610-030
11-digit product format
716100030
Labeler code
71610
Product ID
71610-030_fd96336e-88f7-4dbe-95c3-6af522e39ff8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
divalproex sodium
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA077567
Marketing category
ANDA
Marketing start
2009-01-29
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
71610-030-30Divalproex Sodium30 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE303
71610-030-60Divalproex Sodium90 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE903
71610-030-75Divalproex Sodium150 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE1503
71610-030-80Divalproex Sodium180 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE1803
71610-030-92Divalproex Sodium270 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE2703

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-030-30EA - Each71610-0302abbb182-ce2c-4c2e-8b73-2fa8aef7446012024-06-10
71610-030-60EA - Each71610-0303f699813-d88f-4b9c-afc1-21e9ee3bbdad12018-04-19
71610-030-75EA - Each71610-03017b69eec-f139-4bca-b3f7-9c71c435a33c12018-04-19
71610-030-80EA - Each71610-03058bac01f-e908-47e4-a8cb-5d6b0535bd6012024-04-05
71610-030-92EA - Each71610-0305df67ada-014a-48b1-ae1e-8a34bf284b3212024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-030DIVALPROEX SODIUM TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3Current NDC, Legacy NDC, 5 package rows20230804_bf34dd25-abe3-4587-b481-df052f085429.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099563divalproex sodium 250 MG 24HR Extended Release Oral TabletPSNbf34dd25-abe3-4587-b481-df052f0854293
109956324 HR divalproex sodium 250 MG Extended Release Oral TabletSCDbf34dd25-abe3-4587-b481-df052f0854293
1099563divalproex sodium 250 MG 24 HR Extended Release Oral TabletSYbf34dd25-abe3-4587-b481-df052f0854293

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-030-307161000303030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-030-30) 2018-11-12NoNoCurrent
71610-030-607161000306090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-030-60) 2018-01-180000-00-00NoNoCurrent
71610-030-7571610003075150 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-030-75) 2018-02-090000-00-00NoNoCurrent
71610-030-8071610003080180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-030-80) 2019-07-10NoNoCurrent
71610-030-9271610003092270 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-030-92) 2019-07-10NoNoCurrent