AMRIX
AMRIX (Cyclobenzaprine Hydrochloride Extended-Release Capsules)
Approved
Approval ID
555ff988-280c-4272-bf1f-a911fe2e584d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 8, 2010
Manufacturers
FDA
Rebel Distributors Corp.
DUNS: 118802834
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Cyclobenzaprine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-723
Application NumberNDA021777
Product Classification
M
Marketing Category
C73594
G
Generic Name
Cyclobenzaprine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMarch 18, 2010
FDA Product Classification
INGREDIENTS (10)
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
diethyl phthalateInactive
Code: UF064M00AF
Classification: IACT
cyclobenzaprine hydrochlorideActive
Quantity: 15 mg in 1 1
Code: 0VE05JYS2P
Classification: ACTIM
gelatinInactive
Code: 2G86QN327L
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT