FDA.reportPublic FDA data

valproic acid

Product NDC
43353-085
11-digit product format
433530085
Labeler code
43353
Product ID
43353-085_a83d04b7-84f7-4967-9721-a82a0fe8d83e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
valproic acid
Dosage form
CAPSULE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA073229
Marketing category
ANDA
Marketing start
2011-10-29
Substance
VALPROIC ACID
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
valproic acid
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VALPROIC ACID250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii614OI1Z5WI
Rxcui1099681

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
43353-085-53valproic acid60 in 1 BOTTLECAPSULE603
43353-085-60valproic acid90 in 1 BOTTLECAPSULE903
43353-085-70valproic acid120 in 1 BOTTLECAPSULE1203
43353-085-80valproic acid180 in 1 BOTTLECAPSULE1803
43353-085-90valproic acid240 in 1 BOTTLECAPSULE2403
43353-085-94valproic acid360 in 1 BOTTLECAPSULE3603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-085-53EA - Each43353-0855fd71383-fffd-4a2b-8d91-36795f85de9f12016-07-19
43353-085-60EA - Each43353-085690181a6-c8a5-41e8-a1d1-8639edc7fcd012016-07-19
43353-085-70EA - Each43353-0856cdd945b-f5b1-4e64-997f-ee9821bd020012016-09-02
43353-085-80EA - Each43353-085ae48ce30-ca8e-4df1-8aed-d5cf0854be8812016-07-19
43353-085-90EA - Each43353-0855a5c4214-d397-46b2-97a4-823cbce0598112017-11-06
43353-085-94EA - Each43353-085811c7b1f-6435-4392-8451-72841991e2c112024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-085VALPROIC ACID CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3Current NDC, Legacy NDC, 6 package rows20171018_3904177b-8a26-4356-9080-d2a2e3f468af.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099681valproic acid 250 MG Oral CapsulePSN3904177b-8a26-4356-9080-d2a2e3f468af3
1099681valproic acid 250 MG Oral CapsuleSCD3904177b-8a26-4356-9080-d2a2e3f468af3
1099681VPA 250 MG Oral CapsuleSY3904177b-8a26-4356-9080-d2a2e3f468af3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43353-085-534335300855360 CAPSULE in 1 BOTTLE (43353-085-53) 60 capsule2015-07-200000-00-00NoNoCurrent
43353-085-604335300856090 CAPSULE in 1 BOTTLE (43353-085-60) 90 capsule2015-07-200000-00-00NoNoCurrent
43353-085-7043353008570120 CAPSULE in 1 BOTTLE (43353-085-70) 120 capsule2015-12-160000-00-00NoNoCurrent
43353-085-8043353008580180 CAPSULE in 1 BOTTLE (43353-085-80) 180 capsule2015-12-150000-00-00NoNoCurrent
43353-085-9043353008590240 CAPSULE in 1 BOTTLE (43353-085-90) 240 capsule2016-05-230000-00-00NoNoCurrent
43353-085-9443353008594360 CAPSULE in 1 BOTTLE (43353-085-94) 360 capsule2015-10-280000-00-00NoNoCurrent