FDA.reportPublic FDA data

Valproic Acid

Product NDC
70518-4298
11-digit product format
705184298
Labeler code
70518
Product ID
70518-4298_401e1843-e96b-fda9-e063-6294a90a3073
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valproic Acid
Dosage form
SOLUTION
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA073178
Marketing category
ANDA
Marketing start
2025-02-27
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
70518-4298-0Valproic Acid10 in 1 BOXSOLUTION103
70518-4298-1Valproic Acid20 mL in 1 CUPSOLUTION203
70518-4298-2Valproic Acid10 in 1 BOXSOLUTION103
70518-4298-3Valproic Acid10 mL in 1 CUPSOLUTION103
70518-4298-4Valproic Acid10 in 1 BOXSOLUTION103
70518-4298-5Valproic Acid5 mL in 1 CUPSOLUTION53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4298VALPROIC ACID SOLUTION [REMEDYREPACK INC.]2Current NDC, 6 package rows20250327_1edd220d-d151-4177-9a29-9fee36489fb7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099687valproic acid 250 MG in 5 mL Oral SolutionPSN1edd220d-d151-4177-9a29-9fee36489fb73
1099687valproic acid 50 MG/ML Oral SolutionSCD1edd220d-d151-4177-9a29-9fee36489fb73
1099687valproate sodium 50 MG/ML SyrupSY1edd220d-d151-4177-9a29-9fee36489fb73
1099687valproic acid 250 MG per 5 ML Oral SolutionSY1edd220d-d151-4177-9a29-9fee36489fb73
1099687valproic acid 500 MG per 10 ML Oral SolutionSY1edd220d-d151-4177-9a29-9fee36489fb73
1099687VPA 50 MG/ML Oral SolutionSY1edd220d-d151-4177-9a29-9fee36489fb73

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4298-07051842980010 CUP in 1 BOX (70518-4298-0) / 20 mL in 1 CUP (70518-4298-1) 10 cup2025-02-27NoNoCurrent
70518-4298-17051842980120 mL in 1 CUP20 mlHistorical
70518-4298-27051842980210 CUP in 1 BOX (70518-4298-2) / 10 mL in 1 CUP (70518-4298-3) 10 cup2025-02-27NoNoCurrent
70518-4298-37051842980310 mL in 1 CUP10 mlHistorical
70518-4298-47051842980410 CUP in 1 BOX (70518-4298-4) / 5 mL in 1 CUP (70518-4298-5) 10 cup2025-02-27NoNoCurrent
70518-4298-5705184298055 mL in 1 CUP5 mlHistorical