Cyclobenzaprine Hydrochloride
Cyclobenzaprine Hydrochloride Tablets, USP
Approved
Approval ID
fae7e4a7-ca63-4af4-a43a-c5d85cce1961
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 23, 2011
Manufacturers
FDA
RedPharm Drug Inc.
DUNS: 008039641
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 Code67296-0447
Application NumberANDA078218
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cyclobenzaprine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 23, 2011
FDA Product Classification
INGREDIENTS (13)
CYCLOBENZAPRINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 0VE05JYS2P
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT