Cyclobenzaprine Hydrochloride

Basic Information

Product Name

FDA Product Code

68788-8596

Regulatory Information

NDC Product Code

68788-8596

Application Number

ANDA090478

Marketing Category

C73584

Effective Date

March 15, 2024

Territorial Authority

USA

FDA Title

CYCLOBENZAPRINE HCl TABLETS USP

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

CYCLOBENZAPRINE HYDROCHLORIDE

Quantity: 10 mg in 1 1

Code: 0VE05JYS2P

Class Code: ACTIB

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

HYPROMELLOSE 2910 (3 MPA.S)

Code: 0VUT3PMY82

Class Code: IACT

HYPROMELLOSE 2910 (6 MPA.S)

Code: 0WZ8WG20P6

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

POLYETHYLENE GLYCOL 400

Code: B697894SGQ

Class Code: IACT

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

POLYSORBATE 80

Code: 6OZP39ZG8H

Class Code: IACT

Active Moieties