NDC Code(s) : 69097-410-02, 69097-411-02, 69097-412-02
Packager : Cipla USA Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CINACALCET CINACALCET TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69097-410
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:69097-410-0230 in 1 BOTTLE Type 0: Not a Combination Product03/08/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208915 03/08/2018
CINACALCET CINACALCET TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69097-411
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:69097-411-0230 in 1 BOTTLE Type 0: Not a Combination Product03/08/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208915 03/08/2018
CINACALCET CINACALCET TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69097-412
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:69097-412-0230 in 1 BOTTLE Type 0: Not a Combination Product03/08/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208915 03/08/2018

LABELER - Cipla USA Inc.(078719707)

REGISTRANT - Cipla USA Inc.(078719707)

Establishment
Name Address ID/FEI Business Operations
Cipla Ltd. Patalganga unit II 916940208 ANALYSIS(69097-410, 69097-411, 69097-412), LABEL(69097-410, 69097-411, 69097-412), MANUFACTURE(69097-410, 69097-411, 69097-412), PACK(69097-410, 69097-411, 69097-412)

Establishment
Name Address ID/FEI Business Operations
Cipla Limited- Kurkumbh 917066446 API MANUFACTURE(69097-410, 69097-411, 69097-412), MANUFACTURE(69097-410, 69097-411, 69097-412)

Establishment
Name Address ID/FEI Business Operations
Ascent Pharmaceuticals Inc 080938961 ANALYSIS(69097-410, 69097-411, 69097-412), LABEL(69097-410, 69097-411, 69097-412), MANUFACTURE(69097-410, 69097-411, 69097-412), PACK(69097-410, 69097-411, 69097-412)

PRINCIPAL DISPLAY PANEL

NDC 69097-410-02                      Rx Only

Cinacalcet

Hydrochloride

Tablets

30mg*

30 Tablets

Cipla

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NDC 69097-411-02                      Rx Only

Cinacalcet

Hydrochloride

Tablets

60mg*

30 Tablets

Cipla

image

NDC 69097-412-02                      Rx Only

Cinacalcet

Hydrochloride

Tablets

90mg*

30 Tablets

Cipla

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