Cyclobenzaprine Hydrochloride
Cyclobenzaprine Hydrochloride Tablets, USP Rx only
Approved
Approval ID
29ca9548-23b0-4c50-82cb-4f0564d7e065
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 3, 2023
Manufacturers
FDA
Preferred Pharmaceuticals Inc.
DUNS: 791119022
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 Code68788-8221
Application NumberANDA078643
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cyclobenzaprine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 3, 2023
FDA Product Classification
INGREDIENTS (10)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CYCLOBENZAPRINE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: 0VE05JYS2P
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 5/3/2023
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg
Rising**®**
** PHARMACEUTICALS**
** NDC 68788-8221**
Cyclobenzaprine
** Hydrochloride**
** Tablets, USP**
5 mg
Rx only
Repackaged By: Preferred Pharmaceuticals Inc.
