NDC Code(s) : 76282-674-30, 76282-675-30, 76282-676-30
Packager : EXELAN PHARMACEUTICALS INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CINACALCETCINACALCET TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76282-674
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CINACALCET HYDROCHLORIDE(UNII: 1K860WSG25)
(CINACALCET - UNII:UAZ6V7728S) 		CINACALCET30 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
STARCH, CORN(UNII: O8232NY3SJ)
POVIDONE K30(UNII: U725QWY32X)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CROSPOVIDONE(UNII: 2S7830E561)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
HYPROMELLOSE 2910 (15 MPA.S)(UNII: 36SFW2JZ0W)
Product Characteristics
Color GREEN (Light green) Score no score
Shape OVAL Size 10 mm
Flavor Imprint Code CL;410
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:76282-674-3030 in 1 BOTTLE Type 0: Not a Combination Product14/04/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208915 04/14/2020
CINACALCETCINACALCET TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76282-675
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CINACALCET HYDROCHLORIDE(UNII: 1K860WSG25)
(CINACALCET - UNII:UAZ6V7728S) 		CINACALCET60 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
STARCH, CORN(UNII: O8232NY3SJ)
POVIDONE K30(UNII: U725QWY32X)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CROSPOVIDONE(UNII: 2S7830E561)
HYPROMELLOSE 2910 (15 MPA.S)(UNII: 36SFW2JZ0W)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
TRIACETIN(UNII: XHX3C3X673)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color GREEN (Light green) Score no score
Shape OVAL Size 12 mm
Flavor Imprint Code CL;411
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:76282-675-3030 in 1 BOTTLE Type 0: Not a Combination Product14/04/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208915 04/14/2020
CINACALCETCINACALCET TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76282-676
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CINACALCET HYDROCHLORIDE(UNII: 1K860WSG25)
(CINACALCET - UNII:UAZ6V7728S) 		CINACALCET90 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
STARCH, CORN(UNII: O8232NY3SJ)
POVIDONE K30(UNII: U725QWY32X)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CROSPOVIDONE(UNII: 2S7830E561)
HYPROMELLOSE 2910 (15 MPA.S)(UNII: 36SFW2JZ0W)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color GREEN (Light green) Score no score
Shape OVAL Size 14 mm
Flavor Imprint Code CL;412
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:76282-676-3030 in 1 BOTTLE Type 0: Not a Combination Product14/04/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208915 04/14/2020

LABELER - EXELAN PHARMACEUTICALS INC.(967795266)

PRINCIPAL DISPLAY PANEL

NDC 76282-674-30                     Rx Only

Cinacalcet

Hydrochloride

Tablets

30mg*

30 Tablets

Exelan

image

NDC 76282-675-30                   Rx Only

Cinacalcet

Hydrochloride

Tablets

60mg*

30 Tablets

Exelan

image

NDC 76282-676-30                     Rx Only

Cinacalcet

Hydrochloride

Tablets

90mg*

30 Tablets

Exelan

image