MedPath
FDA Product

CYCLOBENZAPRINE HYDROCHLORIDE

Product approved by U.S. Food and Drug Administration (US)

Basic Information

CYCLOBENZAPRINE HYDROCHLORIDE

60760-767

Regulatory Information

60760-767

ANDA208170

C73584

August 10, 2023

USA

Cyclobenzaprine hydrochloride, USP

HUMAN PRESCRIPTION DRUG LABEL

5

Company Information

063050751

Active Ingredients

CYCLOBENZAPRINE HYDROCHLORIDE

Quantity: 10 mg in 1 1

Code: 0VE05JYS2P

Class Code: ACTIB

ANHYDROUS LACTOSE

Code: 3SY5LH9PMK

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

HYPROMELLOSE, UNSPECIFIED

Code: 3NXW29V3WO

Class Code: IACT

CROSPOVIDONE (15 MPA.S AT 5%)

Code: 68401960MK

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

POLYSORBATE 80

Code: 6OZP39ZG8H

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

POLYETHYLENE GLYCOL 400

Code: B697894SGQ

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

D&C YELLOW NO. 10

Code: 35SW5USQ3G

Class Code: IACT

FD&C YELLOW NO. 6

Code: H77VEI93A8

Class Code: IACT

Active Moieties

CYCLOBENZAPRINE

Code: 69O5WQQ5TI

© Copyright 2025. All Rights Reserved by MedPath