Cyclobenzaprine Hydrochloride
Cyclobenzaprine Hydrochloride Tablets, USP Rx only
Approved
Approval ID
e39f4ef7-acc0-2d35-e053-2995a90a0f84
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 15, 2023
Manufacturers
FDA
St Mary's Medical Park Pharmacy
DUNS: 063050751
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 Code60760-536
Application NumberANDA078643
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cyclobenzaprine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMarch 15, 2023
FDA Product Classification
INGREDIENTS (10)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CYCLOBENZAPRINE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: 0VE05JYS2P
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT