VALPROIC ACID

Product NDC
70752-202
11-digit product format
707520202
Labeler code
70752
Product ID
70752-202_a8e717fe-e79e-46f6-90da-8b8cfe78fae7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VALPROIC ACID
Dosage form
SOLUTION
Route
ORAL
Labeler
QUAGEN PHARMACEUTICALS LLC
Application
ANDA090517
Marketing category
ANDA
Marketing start
2024-04-15
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
70752-202-12VALPROIC ACID473 mL in 1 BOTTLESOLUTION4732
70752-202-12VALPROIC ACID12 in 1 CASESOLUTION122

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70752-202-12ML - Milliliter70752-202110f3e53-3301-44ec-822a-9db461bf00cd12024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70752-202VALPROIC ACID SOLUTION [QUAGEN PHARMACEUTICALS LLC]2Current NDC, 2 package rows20240507_531c0fc7-5e80-49a5-a9d1-0916ec45d52c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099687valproic acid 250 MG in 5 mL Oral SolutionPSN531c0fc7-5e80-49a5-a9d1-0916ec45d52c2
1099687valproic acid 50 MG/ML Oral SolutionSCD531c0fc7-5e80-49a5-a9d1-0916ec45d52c2
1099687valproate sodium 50 MG/ML SyrupSY531c0fc7-5e80-49a5-a9d1-0916ec45d52c2
1099687valproic acid 250 MG per 5 ML Oral SolutionSY531c0fc7-5e80-49a5-a9d1-0916ec45d52c2
1099687valproic acid 500 MG per 10 ML Oral SolutionSY531c0fc7-5e80-49a5-a9d1-0916ec45d52c2
1099687VPA 50 MG/ML Oral SolutionSY531c0fc7-5e80-49a5-a9d1-0916ec45d52c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70752-202-127075202021212 BOTTLE in 1 CASE (70752-202-12) / 473 mL in 1 BOTTLE12 bottle2024-04-15NoNoHistorical