Cyclobenzaprine Hydrochloride

Basic Information

Product Name

FDA Product Code

59746-735

Regulatory Information

NDC Product Code

59746-735

Application Number

ANDA077563

Marketing Category

C73584

Effective Date

November 29, 2017

Territorial Authority

USA

FDA Title

Cyclobenzaprine Hydrochloride Tablets Rx Only

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

Silicon Dioxide

Code: ETJ7Z6XBU4

Class Code: IACT

Cyclobenzaprine Hydrochloride

Quantity: 7.5 mg in 1 1

Code: 0VE05JYS2P

Class Code: ACTIB

Croscarmellose Sodium

Code: M28OL1HH48

Class Code: IACT

Lactose

Code: J2B2A4N98G

Class Code: IACT

Magnesium Stearate

Code: 70097M6I30

Class Code: IACT

Cellulose, Microcrystalline

Code: OP1R32D61U

Class Code: IACT

Talc

Code: 7SEV7J4R1U

Class Code: IACT

Polyethylene Glycol, Unspecified

Code: 3WJQ0SDW1A

Class Code: IACT

Polyvinyl Alcohol, Unspecified

Code: 532B59J990

Class Code: IACT

Titanium Dioxide

Code: 15FIX9V2JP

Class Code: IACT

Active Moieties