Cyclobenzaprine Hydrochloride
CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only
Approved
Approval ID
59b428fa-5013-4b2b-872f-16ba4a9d4f5d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 25, 2023
Manufacturers
FDA
PD-Rx Pharmaceuticals, Inc.
DUNS: 156893695
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 Code72789-115
Application NumberANDA077797
Product Classification
M
Marketing Category
C73584
G
Generic Name
cyclobenzaprine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 25, 2023
FDA Product Classification
INGREDIENTS (12)
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CYCLOBENZAPRINE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: 0VE05JYS2P
Classification: ACTIB
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT