Sensipar
These highlights do not include all the information needed to use SENSIPAR safely and effectively. See full prescribing information for SENSIPAR. SENSIPAR (cinacalcet) tablets, for oral use Initial U.S. Approval: 2004
Approved
Approval ID
8ff022bc-4627-4965-beb1-968deb5b56bc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 6, 2016
Manufacturers
FDA
Carilion Materials Management
DUNS: 079239644
Products 1
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 Code68151-4740
Application NumberNDA021688
Product Classification
M
Marketing Category
C73594
G
Generic Name
cinacalcet hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 25, 2014
FDA Product Classification
INGREDIENTS (8)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CINACALCET HYDROCHLORIDEActive
Quantity: 30 mg in 1 1
Code: 1K860WSG25
Classification: ACTIM
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONESInactive
Code: FZ989GH94E
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT