CYCLOBENZAPRINE HYDROCHLORIDE

Basic Information

Product Name

FDA Product Code

68788-8471

Regulatory Information

NDC Product Code

68788-8471

Application Number

ANDA208170

Marketing Category

C73584

Effective Date

June 29, 2023

Territorial Authority

USA

FDA Title

Cyclobenzaprine hydrochloride, USP

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

ANHYDROUS LACTOSE

Code: 3SY5LH9PMK

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

FD&C BLUE NO. 2

Code: L06K8R7DQK

Class Code: IACT

CROSPOVIDONE (120 .MU.M)

Code: 68401960MK

Class Code: IACT

HYPROMELLOSE, UNSPECIFIED

Code: 3NXW29V3WO

Class Code: IACT

D&C YELLOW NO. 10

Code: 35SW5USQ3G

Class Code: IACT

FD&C YELLOW NO. 6

Code: H77VEI93A8

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

POLYETHYLENE GLYCOL 400

Code: B697894SGQ

Class Code: IACT

POLYSORBATE 80

Code: 6OZP39ZG8H

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

CYCLOBENZAPRINE HYDROCHLORIDE

Quantity: 5 mg in 1 1

Code: 0VE05JYS2P

Class Code: ACTIB

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

Active Moieties