DIVALPROEX SODIUM
These highlights do not include all the information needed to use DIVALPROEX SODIUM DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for DIVALPROEX SODIUM DELAYED-RELEASE CAPSULES. DIVALPROEX SODIUM delayed-release capsules, for oral use Initial U.S. Approval: 1989
Approved
Approval ID
8e86a610-45ef-4be7-a3ab-f656f5b32706
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 21, 2022
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 Code55154-4759
Application NumberANDA078919
Product Classification
M
Marketing Category
C73584
G
Generic Name
DIVALPROEX SODIUM
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 5, 2018
FDA Product Classification
INGREDIENTS (11)
DIVALPROEX SODIUMActive
Quantity: 125 mg in 1 1
Code: 644VL95AO6
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive
Code: 74G4R6TH13
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT