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 useInitial U.S. Approval: 2004
Approved
Approval ID
19a3f3cb-2136-44cc-a35b-5a07fcdc784f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 23, 2023
Manufacturers
FDA
Strides Pharma Inc.
DUNS: 078310501
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 Code42543-962
Application NumberANDA209226
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cinacalcet
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 23, 2023
FDA Product Classification
INGREDIENTS (14)
CINACALCET HYDROCHLORIDEActive
Quantity: 60 mg in 1 1
Code: 1K860WSG25
Classification: ACTIM
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
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 Code42543-963
Application NumberANDA209226
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cinacalcet
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 23, 2023
FDA Product Classification
INGREDIENTS (14)
CINACALCET HYDROCHLORIDEActive
Quantity: 90 mg in 1 1
Code: 1K860WSG25
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
Cinacalcet
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42543-961
Application NumberANDA209226
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cinacalcet
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 23, 2023
FDA Product Classification
INGREDIENTS (14)
CINACALCET HYDROCHLORIDEActive
Quantity: 30 mg in 1 1
Code: 1K860WSG25
Classification: ACTIM
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT