Products4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Qsymia
Product Details
NDC Product Code
62541-203Application Number
NDA022580Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
December 11, 2023SUCROSEInactive
Code: C151H8M554Class: IACT
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4BClass: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1MClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
Code: 0K2I505OTVClass: ACTIMQuantity: 11.25 mg in 1 1
TopiramateActive
Code: 0H73WJJ391Class: ACTIBQuantity: 69 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
Qsymia
Product Details
NDC Product Code
62541-204Application Number
NDA022580Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
December 11, 2023SUCROSEInactive
Code: C151H8M554Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4BClass: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1MClass: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
Code: 0K2I505OTVClass: ACTIMQuantity: 15 mg in 1 1
TopiramateActive
Code: 0H73WJJ391Class: ACTIBQuantity: 92 mg in 1 1
Qsymia
Product Details
NDC Product Code
62541-201Application Number
NDA022580Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
December 11, 2023SUCROSEInactive
Code: C151H8M554Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4BClass: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQYClass: IACT
TopiramateActive
Code: 0H73WJJ391Class: ACTIBQuantity: 23 mg in 1 1
Code: 0K2I505OTVClass: ACTIMQuantity: 3.75 mg in 1 1
Qsymia
Product Details
NDC Product Code
62541-202Application Number
NDA022580Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
December 11, 2023FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
Code: 0K2I505OTVClass: ACTIMQuantity: 7.5 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4BClass: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQYClass: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1MClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
TopiramateActive
Code: 0H73WJJ391Class: ACTIBQuantity: 46 mg in 1 1