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
6bad4e06-c0a1-4123-83c2-67d3b081e8a9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 23, 2023
Manufacturers
FDA
Accord Healthcare, Inc.
DUNS: 604222237
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 Code16729-440
Application NumberANDA211892
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cinacalcet
Product Specifications
Route of AdministrationORAL
Effective DateNovember 23, 2023
FDA Product Classification
INGREDIENTS (9)
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
CINACALCET HYDROCHLORIDEActive
Quantity: 30 mg in 1 1
Code: 1K860WSG25
Classification: ACTIM
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Cinacalcet
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16729-441
Application NumberANDA211892
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cinacalcet
Product Specifications
Route of AdministrationORAL
Effective DateNovember 23, 2023
FDA Product Classification
INGREDIENTS (9)
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
CINACALCET HYDROCHLORIDEActive
Quantity: 60 mg in 1 1
Code: 1K860WSG25
Classification: ACTIM
Cinacalcet
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16729-442
Application NumberANDA211892
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cinacalcet
Product Specifications
Route of AdministrationORAL
Effective DateNovember 23, 2023
FDA Product Classification
INGREDIENTS (9)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CINACALCET HYDROCHLORIDEActive
Quantity: 90 mg in 1 1
Code: 1K860WSG25
Classification: ACTIM
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT