FDA.reportPublic FDA data

Valproic Acid

Product NDC
62559-266
11-digit product format
625590266
Labeler code
62559
Product ID
62559-266_36e8a44c-2c80-4c44-8cad-9ea6de9807c3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valproic Acid
Dosage form
SOLUTION
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Valproic Acid
Listing expiration
2027-12-31

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
62559-266-16Valproic Acid473 mL in 1 BOTTLESOLUTION4733

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62559-266-16ML - Milliliter62559-26671148f16-81cd-4bce-a20d-10b80866e49812024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62559-266VALPROIC ACID SOLUTION [ANI PHARMACEUTICALS, INC.]1Current NDC, 1 package rows20240104_2314af65-b928-42a9-91eb-6372909ab4f5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099687valproic acid 250 MG in 5 mL Oral SolutionPSN2314af65-b928-42a9-91eb-6372909ab4f53
1099687valproic acid 250 MG in 5 mL Oral SolutionPSN1edd220d-d151-4177-9a29-9fee36489fb73
1099687valproic acid 50 MG/ML Oral SolutionSCD2314af65-b928-42a9-91eb-6372909ab4f53
1099687valproic acid 50 MG/ML Oral SolutionSCD1edd220d-d151-4177-9a29-9fee36489fb73
1099687valproate sodium 50 MG/ML SyrupSY1edd220d-d151-4177-9a29-9fee36489fb73
1099687valproate sodium 50 MG/ML SyrupSY2314af65-b928-42a9-91eb-6372909ab4f53
1099687valproic acid 250 MG per 5 ML Oral SolutionSY2314af65-b928-42a9-91eb-6372909ab4f53
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
1099687valproic acid 500 MG per 10 ML Oral SolutionSY2314af65-b928-42a9-91eb-6372909ab4f53
1099687VPA 50 MG/ML Oral SolutionSY1edd220d-d151-4177-9a29-9fee36489fb73
1099687VPA 50 MG/ML Oral SolutionSY2314af65-b928-42a9-91eb-6372909ab4f53
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
62559-266-1662559026616473 mL in 1 BOTTLE (62559-266-16) 473 ml2024-01-02NoNoCurrent