FDA.reportPublic FDA data

Valproic Acid

Product NDC
81033-266
11-digit product format
810330266
Labeler code
81033
Product ID
81033-266_3a214bf4-ea91-0892-e063-6394a90a9a9d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valproic Acid
Dosage form
SOLUTION
Route
ORAL
Labeler
Kesin Pharma Corporation
Application
ANDA073178
Marketing category
ANDA
Marketing start
2024-01-02
Substance
VALPROIC ACID
Active strength
250 mg/5mL
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/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii614OI1Z5WI
Rxcui1099687

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
81033-266-05Valproic Acid5 mL in 1 CUP, UNIT-DOSESOLUTION51
81033-266-10Valproic Acid10 mL in 1 CUP, UNIT-DOSESOLUTION101
81033-266-50Valproic Acid100 in 1 CASESOLUTION1001
81033-266-52Valproic Acid100 in 1 CASESOLUTION1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81033-266-05ML - Milliliter81033-2660e918f4b-2558-44b5-bb1a-5f2a18addcf112025-09-12
81033-266-10ML - Milliliter81033-2664ff50bef-181f-4872-9918-00bb9f24e7f112025-09-12
81033-266-50ML - Milliliter81033-266e85923ff-6684-4dc2-983d-12e775b40a6912025-09-12
81033-266-52ML - Milliliter81033-266f992c861-18e9-4cd6-8efd-3dd0fd03ae7712025-09-12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099687valproic acid 250 MG in 5 mL Oral SolutionPSN3a2155d0-e79d-3e11-e063-6294a90a4aae1
1099687valproic acid 50 MG/ML Oral SolutionSCD3a2155d0-e79d-3e11-e063-6294a90a4aae1
1099687valproate sodium 50 MG/ML SyrupSY3a2155d0-e79d-3e11-e063-6294a90a4aae1
1099687valproic acid 250 MG per 5 ML Oral SolutionSY3a2155d0-e79d-3e11-e063-6294a90a4aae1
1099687valproic acid 500 MG per 10 ML Oral SolutionSY3a2155d0-e79d-3e11-e063-6294a90a4aae1
1099687VPA 50 MG/ML Oral SolutionSY3a2155d0-e79d-3e11-e063-6294a90a4aae1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81033-266-05810330266055 mL in 1 CUP, UNIT-DOSE5 mlHistorical
81033-266-108103302661010 mL in 1 CUP, UNIT-DOSE10 mlHistorical
81033-266-5081033026650100 CUP, UNIT-DOSE in 1 CASE (81033-266-50) / 5 mL in 1 CUP, UNIT-DOSE (81033-266-05) 2025-08-01NoNoHistorical
81033-266-5281033026652100 CUP, UNIT-DOSE in 1 CASE (81033-266-52) / 10 mL in 1 CUP, UNIT-DOSE (81033-266-10) 2025-08-01NoNoHistorical