QUDEXY XR

Basic Information

Product Name

QUDEXY XR

FDA Product Code

0245-1073

Regulatory Information

NDC Product Code

0245-1073

Application Number

NDA205122

Marketing Category

C73594

Effective Date

May 31, 2023

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use QUDEXY XR safely and effectively. See full prescribing information for QUDEXY XR. QUDEXY XR (topiramate) extended-release capsules, for oral use Initial U.S. Approval: 1996

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

microcrystalline cellulose

Code: OP1R32D61U

Class Code: IACT

Topiramate

Quantity: 200 mg in 1 1

Code: 0H73WJJ391

Class Code: ACTIB

ethylcellulose, unspecified

Code: 7Z8S9VYZ4B

Class Code: IACT

ferrosoferric oxide

Code: XM0M87F357

Class Code: IACT

titanium dioxide

Code: 15FIX9V2JP

Class Code: IACT

diethyl phthalate

Code: UF064M00AF

Class Code: IACT

ferric oxide yellow

Code: EX438O2MRT

Class Code: IACT

ferric oxide red

Code: 1K09F3G675

Class Code: IACT

hypromellose 2910 (6 MPA.S)

Code: 0WZ8WG20P6

Class Code: IACT

Active Moieties

Topiramate

Code: 0H73WJJ391

Basic Information

Regulatory Information

Company Information

Active Ingredients

microcrystalline cellulose

ethylcellulose, unspecified

ferrosoferric oxide

titanium dioxide

diethyl phthalate

ferric oxide yellow

ferric oxide red

hypromellose 2910 (6 MPA.S)

Active Moieties

Topiramate