Qsymia

Basic Information

Product Name

Qsymia

FDA Product Code

62541-202

Regulatory Information

NDC Product Code

62541-202

Application Number

NDA022580

Marketing Category

C73594

Effective Date

December 11, 2023

Territorial Authority

USA

FDA Title

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

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

FD&C YELLOW NO. 6

Code: H77VEI93A8

Class Code: IACT

PHENTERMINE HYDROCHLORIDE

Quantity: 7.5 mg in 1 1

Code: 0K2I505OTV

Class Code: ACTIM

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

ETHYLCELLULOSE, UNSPECIFIED

Code: 7Z8S9VYZ4B

Class Code: IACT

POVIDONE K30

Code: U725QWY32X

Class Code: IACT

GELATIN, UNSPECIFIED

Code: 2G86QN327L

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

FD&C BLUE NO. 1

Code: H3R47K3TBD

Class Code: IACT

FD&C RED NO. 3

Code: PN2ZH5LOQY

Class Code: IACT

FD&C YELLOW NO. 5

Code: I753WB2F1M

Class Code: IACT

SUCROSE

Code: C151H8M554

Class Code: IACT

TOPIRAMATE

Quantity: 46 mg in 1 1

Code: 0H73WJJ391

Class Code: ACTIB

Active Moieties

PHENTERMINE

Code: C045TQL4WP

TOPIRAMATE

Code: 0H73WJJ391

Basic Information

Regulatory Information

Company Information

Active Ingredients

FD&C YELLOW NO. 6

STARCH, CORN

MICROCRYSTALLINE CELLULOSE

ETHYLCELLULOSE, UNSPECIFIED

POVIDONE K30

GELATIN, UNSPECIFIED

TALC

TITANIUM DIOXIDE

FD&C BLUE NO. 1

FD&C RED NO. 3

FD&C YELLOW NO. 5

SUCROSE

Active Moieties

PHENTERMINE

TOPIRAMATE