VALPROIC ACID
Valproic Acid
Approved
Approval ID
4067a52d-c3fa-4531-8e4f-9675e494065f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 22, 2010
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
valproic acid
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-417
Application NumberANDA073484
Product Classification
M
Marketing Category
C73584
G
Generic Name
valproic acid
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 25, 2008
FDA Product Classification
INGREDIENTS (7)
valproic acidActive
Quantity: 250 mg in 1 1
Code: 614OI1Z5WI
Classification: ACTIB
CORN OILInactive
Code: 8470G57WFM
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
glycerinInactive
Code: PDC6A3C0OX
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
gelatinInactive
Code: 2G86QN327L
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT