Cinacalcet
These highlights do not include all the information needed to use CINACALCET TABLETS safely and effectively. See full prescribing information for CINACALCET TABLETS. CINACALCET tablets, for oral use Initial U.S. Approval: 2004
Approved
Approval ID
092553cf-1bcd-4c19-9adf-b46f2bda5c9e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 17, 2021
Manufacturers
FDA
Sun Pharmaceutical Industries, Inc.
DUNS: 146974886
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Cinacalcet
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code47335-379
Application NumberANDA207008
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cinacalcet
Product Specifications
Route of AdministrationORAL
Effective DateDecember 20, 2021
FDA Product Classification
INGREDIENTS (14)
CINACALCET HYDROCHLORIDEActive
Quantity: 30 mg in 1 1
Code: 1K860WSG25
Classification: ACTIM
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
Cinacalcet
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code47335-380
Application NumberANDA207008
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cinacalcet
Product Specifications
Route of AdministrationORAL
Effective DateDecember 20, 2021
FDA Product Classification
INGREDIENTS (14)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CINACALCET HYDROCHLORIDEActive
Quantity: 60 mg in 1 1
Code: 1K860WSG25
Classification: ACTIM
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
Cinacalcet
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code47335-600
Application NumberANDA207008
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cinacalcet
Product Specifications
Route of AdministrationORAL
Effective DateDecember 20, 2021
FDA Product Classification
INGREDIENTS (14)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CINACALCET HYDROCHLORIDEActive
Quantity: 90 mg in 1 1
Code: 1K860WSG25
Classification: ACTIM
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT