VALPROIC ACID

Product NDC
0527-5250
11-digit product format
005275250
Labeler code
0527
Product ID
0527-5250_c72bdbdd-4aac-46ad-95a7-4d79690e9031
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VALPROIC ACID
Dosage form
SOLUTION
Route
ORAL
Labeler
Lannett Company, Inc.
Application
ANDA077960
Marketing category
ANDA
Marketing start
2006-10-13
Marketing end
0000-00-00
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
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0527-5250-70ML - Milliliter0527-5250e85ae49e-3418-45a1-9ce3-4f4c810f63da12020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0527-5250VALPROIC ACID SOLUTION [LANNETT COMPANY, INC.]5Legacy NDC20201002_027c77dd-3051-4beb-b132-f73d6c165529.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0527-5250-7000527525070473 mL in 1 BOTTLE (0527-5250-70) 473 ml2006-10-130000-00-00NoNoCurrent