Sensipar
Sensipar (cinacalcet) Tablets
Approved
Approval ID
8f390187-1071-4000-b778-1d21c518cc9c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 8, 2010
Manufacturers
FDA
State of Florida DOH Central Pharmacy
DUNS: 829348114
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
cinacalcet hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53808-0578
Application NumberNDA021688
Product Classification
M
Marketing Category
C73594
G
Generic Name
cinacalcet hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJune 8, 2010
FDA Product Classification
INGREDIENTS (8)
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CINACALCET HYDROCHLORIDEActive
Quantity: 60 mg in 1 1
Code: 1K860WSG25
Classification: ACTIB
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
cinacalcet hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53808-0577
Application NumberNDA021688
Product Classification
M
Marketing Category
C73594
G
Generic Name
cinacalcet hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJune 8, 2010
FDA Product Classification
INGREDIENTS (8)
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
CINACALCET HYDROCHLORIDEActive
Quantity: 30 mg in 1 1
Code: 1K860WSG25
Classification: ACTIB
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT