Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Preferred Pharmaceuticals Inc.

DUNS Number

791119022

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Preferred Pharmaceuticals Inc.

Labeler

Preferred Pharmaceuticals Inc.

Registrant

Preferred Pharmaceuticals Inc.

DUNS Number

791119022

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Cyclobenzaprine Hydrochloride

Product Details

NDC Product Code

68788-8221

Application Number

ANDA078643

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

May 3, 2023

Ingredients

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

CyclobenzaprineActive

Code: 0VE05JYS2PClass: ACTIBQuantity: 5 mg in 1 1

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQClass: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.