Cyclobenzaprine Hydrochloride
CYCLOBENZAPRINE HYDROCHLORIDE TABLETS USP
Approved
Approval ID
6a682677-4a99-43a5-a991-af7f2d69aca1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 24, 2013
Manufacturers
FDA
MedVantx, Inc.
DUNS: 806427725
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 Code66116-527
Application NumberANDA074421
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cyclobenzaprine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 24, 2013
FDA Product Classification
INGREDIENTS (16)
CYCLOBENZAPRINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 0VE05JYS2P
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT