CYCLOBENZAPRINE HYDROCHLORIDE
Approved
Approval ID
c68204a7-d00c-4ce7-bfda-bff58b2ed67e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 3, 2011
Manufacturers
FDA
STAT RX USA LLC
DUNS: 786036330
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 Code16590-544
Application NumberANDA071611
Product Classification
M
Marketing Category
C73584
G
Generic Name
CYCLOBENZAPRINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateJune 3, 2011
FDA Product Classification
INGREDIENTS (10)
CYCLOBENZAPRINE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: 0VE05JYS2P
Classification: ACTIB
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT