cinacalcet hydrochloride
These highlights do not include all the information needed to use CINACALCET HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for CINACALCET HYDROCHLORIDE TABLETS. CINACALCET HYDROCHLORIDE tablets, for oral useInitial U.S. Approval: 2004
Approved
Approval ID
0850ec78-ae46-481e-a6b5-8169cb843eab
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 21, 2020
Manufacturers
FDA
Slate Run Pharmaceuticals
DUNS: 039452765
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 Code70436-008
Application NumberANDA210207
Product Classification
M
Marketing Category
C73584
G
Generic Name
cinacalcet hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMarch 5, 2019
FDA Product Classification
INGREDIENTS (12)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONE (12 MPA.S AT 5%)Inactive
Code: 40UAA97IT9
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
CINACALCET HYDROCHLORIDEActive
Quantity: 60 mg in 1 1
Code: 1K860WSG25
Classification: ACTIM
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
HYPROMELLOSE 2208 (100 MPA.S)Inactive
Code: B1QE5P712K
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
cinacalcet hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70436-009
Application NumberANDA210207
Product Classification
M
Marketing Category
C73584
G
Generic Name
cinacalcet hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMarch 5, 2019
FDA Product Classification
INGREDIENTS (12)
CROSPOVIDONE (12 MPA.S AT 5%)Inactive
Code: 40UAA97IT9
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
HYPROMELLOSE 2208 (100 MPA.S)Inactive
Code: B1QE5P712K
Classification: IACT
CINACALCET HYDROCHLORIDEActive
Quantity: 90 mg in 1 1
Code: 1K860WSG25
Classification: ACTIM
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
cinacalcet hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70436-007
Application NumberANDA210207
Product Classification
M
Marketing Category
C73584
G
Generic Name
cinacalcet hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMarch 5, 2019
FDA Product Classification
INGREDIENTS (12)
CINACALCET HYDROCHLORIDEActive
Quantity: 30 mg in 1 1
Code: 1K860WSG25
Classification: ACTIM
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONE (12 MPA.S AT 5%)Inactive
Code: 40UAA97IT9
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
HYPROMELLOSE 2208 (100 MPA.S)Inactive
Code: B1QE5P712K
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT