FDA.reportPublic FDA data

Valproic Acid

Product NDC
43353-279
11-digit product format
433530279
Labeler code
43353
Product ID
43353-279_1f5efbea-ccd0-4213-9324-769b0077144f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valproic Acid
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA073484
Marketing category
ANDA
Marketing start
2016-07-15
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
43353-279-53Valproic Acid60 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED602
43353-279-60Valproic Acid90 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED902
43353-279-70Valproic Acid120 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED1202
43353-279-80Valproic Acid180 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED1802
43353-279-90Valproic Acid240 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED2402
43353-279-94Valproic Acid360 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED3602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-279-53EA - Each43353-279e0c4474c-05bf-452a-b31f-b8df03ed0cc412017-11-06
43353-279-60EA - Each43353-279b22579ab-b213-4d0f-87ab-63dd16e261d312017-11-06
43353-279-70EA - Each43353-2794aa207a3-c780-4904-b333-115e66332fe212017-11-06
43353-279-80EA - Each43353-27997fc9357-f508-493a-9177-24a3e3078ddc12017-11-06
43353-279-90EA - Each43353-279074ec88f-7fcb-485f-93fb-7acf21a9c42112017-11-06
43353-279-94EA - Each43353-2798142e08a-de4f-4b6d-bc28-58b31590825012017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-279VALPROIC ACID CAPSULE, LIQUID FILLED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, Legacy NDC, 6 package rows20171021_3798f957-8b32-4ac0-8fd1-80283414c255.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099681valproic acid 250 MG Oral CapsulePSN3798f957-8b32-4ac0-8fd1-80283414c2552
1099681valproic acid 250 MG Oral CapsuleSCD3798f957-8b32-4ac0-8fd1-80283414c2552
1099681VPA 250 MG Oral CapsuleSY3798f957-8b32-4ac0-8fd1-80283414c2552

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43353-279-534335302795360 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (43353-279-53) 2017-02-110000-00-00NoNoCurrent
43353-279-604335302796090 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (43353-279-60) 2017-02-110000-00-00NoNoCurrent
43353-279-7043353027970120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (43353-279-70) 2017-02-160000-00-00NoNoCurrent
43353-279-8043353027980180 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (43353-279-80) 2017-02-110000-00-00NoNoCurrent
43353-279-9043353027990240 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (43353-279-90) 2017-04-250000-00-00NoNoCurrent
43353-279-9443353027994360 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (43353-279-94) 2017-03-070000-00-00NoNoCurrent