Cinacalcet
Cinacalcet Tablets Rx Only These highlights do not include all the information needed to use CINACALCET TABLETS safely and effectively. See full prescribing information for CINACALCET TABLETS. Initial U.S. Approval: 2004
Approved
Approval ID
c81dce3a-8f66-4a99-e053-2a95a90a9a10
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 9, 2024
Manufacturers
FDA
AvKARE
DUNS: 796560394
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 Code42291-460
Application NumberANDA206125
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cinacalcet
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 9, 2024
FDA Product Classification
INGREDIENTS (15)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
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 Code42291-461
Application NumberANDA206125
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cinacalcet
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 9, 2024
FDA Product Classification
INGREDIENTS (15)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
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
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
Cinacalcet
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42291-459
Application NumberANDA206125
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cinacalcet
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 9, 2024
FDA Product Classification
INGREDIENTS (15)
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CINACALCET HYDROCHLORIDEActive
Quantity: 30 mg in 1 1
Code: 1K860WSG25
Classification: ACTIM
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT