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
45028573-13c4-4c8b-ae62-6c75bba97c81
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 18, 2022
Manufacturers
FDA
Amgen Inc
DUNS: 039976196
Products 3
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 Code55513-074
Application NumberNDA021688
Product Classification
M
Marketing Category
C73594
G
Generic Name
cinacalcet hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 5, 2019
FDA Product Classification
INGREDIENTS (8)
CINACALCET HYDROCHLORIDEActive
Quantity: 60 mg in 1 1
Code: 1K860WSG25
Classification: ACTIM
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
cinacalcet hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55513-073
Application NumberNDA021688
Product Classification
M
Marketing Category
C73594
G
Generic Name
cinacalcet hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 5, 2019
FDA Product Classification
INGREDIENTS (8)
CINACALCET HYDROCHLORIDEActive
Quantity: 30 mg in 1 1
Code: 1K860WSG25
Classification: ACTIM
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
cinacalcet hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55513-075
Application NumberNDA021688
Product Classification
M
Marketing Category
C73594
G
Generic Name
cinacalcet hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 5, 2019
FDA Product Classification
INGREDIENTS (8)
CINACALCET HYDROCHLORIDEActive
Quantity: 90 mg in 1 1
Code: 1K860WSG25
Classification: ACTIM
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT