Cyclobenzaprine Hydrochloride
CYCLOBENZAPRINE HYDROCHLORIDE TABLETS USP
Approved
Approval ID
ac490da0-6347-4f5d-bcae-c23261b43725
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 9, 2013
Manufacturers
FDA
Mutual Pharmaceutical
DUNS: 121735955
Products 2
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 Code53489-591
Application NumberANDA073541
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cyclobenzaprine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 13, 2013
FDA Product Classification
INGREDIENTS (9)
Cyclobenzaprine HydrochlorideActive
Quantity: 10 mg in 1 1
Code: 0VE05JYS2P
Classification: ACTIB
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
hypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
lactoseInactive
Code: J2B2A4N98G
Classification: IACT
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
polyethylene glycolsInactive
Code: 3WJQ0SDW1A
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
Cyclobenzaprine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53489-590
Application NumberANDA073541
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cyclobenzaprine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 13, 2013
FDA Product Classification
INGREDIENTS (9)
Cyclobenzaprine HydrochlorideActive
Quantity: 5 mg in 1 1
Code: 0VE05JYS2P
Classification: ACTIB
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
hypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
lactoseInactive
Code: J2B2A4N98G
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
polyethylene glycolsInactive
Code: 3WJQ0SDW1A
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT