Cyclobenzaprine Hydrochloride

Basic Information

Product Name

FDA Product Code

76420-033

Regulatory Information

NDC Product Code

76420-033

Application Number

ANDA077797

Marketing Category

C73584

Effective Date

March 2, 2023

Territorial Authority

USA

FDA Title

CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

FD&C YELLOW NO. 6

Code: H77VEI93A8

Class Code: IACT

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

HYPROMELLOSES

Code: 3NXW29V3WO

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

POLYETHYLENE GLYCOL, UNSPECIFIED

Code: 3WJQ0SDW1A

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

D&C YELLOW NO. 10

Code: 35SW5USQ3G

Class Code: IACT

POLYSORBATE 80

Code: 6OZP39ZG8H

Class Code: IACT

CYCLOBENZAPRINE HYDROCHLORIDE

Quantity: 10 mg in 1 1

Code: 0VE05JYS2P

Class Code: ACTIB

Active Moieties