Fexmid
Fexmidcyclobenzaprine HCl7.5 mg Tablets USP
Approved
Approval ID
99aca2c3-afe6-4f74-83b8-beb08bb2b502
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 13, 2011
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 Code21695-830
Application NumberANDA071611
Product Classification
M
Marketing Category
C73584
G
Generic Name
cyclobenzaprine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 7, 2011
FDA Product Classification
INGREDIENTS (10)
cyclobenzaprine hydrochlorideActive
Quantity: 7.5 mg in 1 1
Code: 0VE05JYS2P
Classification: ACTIB
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
anhydrous DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT