Divalproex Sodium
DIVALPROEX SODIUM DELAYED-RELEASE TABLETS
Approved
Approval ID
0fddf30c-60f0-4d15-b598-ee414988619c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 21, 2010
Manufacturers
FDA
TYA Pharmaceuticals
DUNS: 938389038
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Divalproex Sodium
PRODUCT DETAILS
NDC Product Code64725-0798
Application NumberANDA078597
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 21, 2010
Generic NameDivalproex Sodium
INGREDIENTS (15)
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
D&C RED NO. 30Inactive
Code: 2S42T2808B
Classification: IACT
DIVALPROEX SODIUMActive
Quantity: 500 mg in 1 1
Code: 644VL95AO6
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
Divalproex Sodium
PRODUCT DETAILS
NDC Product Code64725-0797
Application NumberANDA078597
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 21, 2010
Generic NameDivalproex Sodium
INGREDIENTS (14)
DIVALPROEX SODIUMActive
Quantity: 250 mg in 1 1
Code: 644VL95AO6
Classification: ACTIM
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT