Divalproex Sodium
These highlights do not include all the information needed to use DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS. DIVALPROEX SODIUM extended-release tablets, for oral use Initial U.S. Approval: 2000
Approved
Approval ID
283af6d2-8ea2-4225-b2e7-a2057dbdb793
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 27, 2023
Manufacturers
FDA
Cardinal Health 107, LLC
DUNS: 118546603
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Divalproex Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55154-2345
Application NumberANDA203730
Product Classification
M
Marketing Category
C73584
G
Generic Name
Divalproex Sodium
Product Specifications
Route of AdministrationORAL
Effective DateApril 27, 2023
FDA Product Classification
INGREDIENTS (18)
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
DIVALPROEX SODIUMActive
Quantity: 500 mg in 1 1
Code: 644VL95AO6
Classification: ACTIM
ETHYL ACRYLATEInactive
Code: 71E6178C9T
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive
Code: 74G4R6TH13
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT