Qsymia
These highlights do not include all the information needed to use QSYMIA safely and effectively. See full prescribing information for QSYMIA. QSYMIA (phentermine and topiramate extended-release capsules), for oral use, CIV Initial U.S. Approval: 2012
Approved
Approval ID
40dd5602-53da-45ac-bb4b-15789aba40f9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 11, 2023
Manufacturers
FDA
Vivus LLC
DUNS: 782772263
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
phentermine and topiramate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62541-203
Application NumberNDA022580
Product Classification
M
Marketing Category
C73594
G
Generic Name
phentermine and topiramate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 11, 2023
FDA Product Classification
INGREDIENTS (12)
SUCROSEInactive
Code: C151H8M554
Classification: IACT
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4B
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
PHENTERMINE HYDROCHLORIDEActive
Quantity: 11.25 mg in 1 1
Code: 0K2I505OTV
Classification: ACTIM
TOPIRAMATEActive
Quantity: 69 mg in 1 1
Code: 0H73WJJ391
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
phentermine and topiramate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62541-204
Application NumberNDA022580
Product Classification
M
Marketing Category
C73594
G
Generic Name
phentermine and topiramate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 11, 2023
FDA Product Classification
INGREDIENTS (12)
SUCROSEInactive
Code: C151H8M554
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4B
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
PHENTERMINE HYDROCHLORIDEActive
Quantity: 15 mg in 1 1
Code: 0K2I505OTV
Classification: ACTIM
TOPIRAMATEActive
Quantity: 92 mg in 1 1
Code: 0H73WJJ391
Classification: ACTIB
phentermine and topiramate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62541-201
Application NumberNDA022580
Product Classification
M
Marketing Category
C73594
G
Generic Name
phentermine and topiramate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 11, 2023
FDA Product Classification
INGREDIENTS (12)
SUCROSEInactive
Code: C151H8M554
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4B
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
TOPIRAMATEActive
Quantity: 23 mg in 1 1
Code: 0H73WJJ391
Classification: ACTIB
PHENTERMINE HYDROCHLORIDEActive
Quantity: 3.75 mg in 1 1
Code: 0K2I505OTV
Classification: ACTIM
phentermine and topiramate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62541-202
Application NumberNDA022580
Product Classification
M
Marketing Category
C73594
G
Generic Name
phentermine and topiramate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 11, 2023
FDA Product Classification
INGREDIENTS (14)
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
PHENTERMINE HYDROCHLORIDEActive
Quantity: 7.5 mg in 1 1
Code: 0K2I505OTV
Classification: ACTIM
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4B
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TOPIRAMATEActive
Quantity: 46 mg in 1 1
Code: 0H73WJJ391
Classification: ACTIB