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FDA Product

CYCLOBENZAPRINE HCI

Product approved by U.S. Food and Drug Administration (US)

Basic Information

CYCLOBENZAPRINE HCI

61919-681

Regulatory Information

61919-681

ANDA078722

C73584

June 6, 2023

USA

CYCLOBENZAPRINE HCI

HUMAN PRESCRIPTION DRUG LABEL

12

Company Information

DIRECTRX

079254320

Active Ingredients

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

HYPROMELLOSE, UNSPECIFIED

Code: 3NXW29V3WO

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

CYCLOBENZAPRINE HYDROCHLORIDE

Quantity: 7.5 mg in 1 1

Code: 0VE05JYS2P

Class Code: ACTIB

POLYETHYLENE GLYCOL, UNSPECIFIED

Code: 3WJQ0SDW1A

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)

Code: RFW2ET671P

Class Code: IACT

Active Moieties

ANHYDROUS LACTOSE

Code: 3SY5LH9PMK

CYCLOBENZAPRINE

Code: 69O5WQQ5TI

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