Sensipar (Page 7 of 7)

PRINCIPAL DISPLAY PANEL

AMGEN®

NDC 55513-074-30

Sensipar®

(cinacalcet) Tablets

Rx Only

30 tablets

60 mg

Each tablet contains:

Cinacalcet 60 mg (equivalent to 66 mg of cinacalcet hydrochloride).

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).

See USP controlled room temperature.

Dispense in tight, light-resistant container per USP.

Dosage : See Package Insert.

© 2004-2018 Amgen Inc. All rights reserved.

Patent : http://pat.amgen.com/sensipar/

Distributed by : Amgen,

One Amgen Center Drive,

Thousand Oaks, CA 91320-1799

Made in Japan

PRINCIPAL DISPLAY PANEL
AMGEN®
NDC 55513-074-30
Sensipar®
(cinacalcet ) Tablets
Rx Only 
30 tablets
60 mg
Each tablet contains :
Cinacalcet 60 mg (equivalent to 66 mg of cinacalcet hydrochloride).
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).
See USP controlled room temperature.
Dispense in tight, light-resistant container per USP.
Dosage : See Package Insert.
© 2004-2018 Amgen Inc. All rights reserved.
Patent : http://pat.amgen.com/sensipar/
Distributed by : Amgen,
One Amgen Center Drive,
Thousand Oaks, CA 91320-1799
Made in Japan
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

AMGEN®

NDC 55513-075-30

Sensipar®

(cinacalcet) Tablets

Rx Only

30 tablets

90 mg

Each tablet contains:

Cinacalcet 90 mg (equivalent to 99 mg of cinacalcet hydrochloride).

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).

See USP controlled room temperature.

Dispense in tight, light-resistant container per USP.

Dosage : See Package Insert.

© 2004-2018 Amgen Inc. All rights reserved.

Patent : http://pat.amgen.com/sensipar/

Distributed by : Amgen,

One Amgen Center Drive,

Thousand Oaks, CA 91320-1799

Made in Japan

PRINCIPAL DISPLAY PANEL
AMGEN®
NDC 55513-075-30
Sensipar®
(cinacalcet ) Tablets
Rx Only 
30 tablets
90 mg
Each tablet contains :
Cinacalcet 90 mg (equivalent to 99 mg of cinacalcet hydrochloride).
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).
See USP controlled room temperature.
Dispense in tight, light-resistant container per USP.
Dosage : See Package Insert.
© 2004-2018 Amgen Inc. All rights reserved.
Patent : http://pat.amgen.com/sensipar/
Distributed by : Amgen,
One Amgen Center Drive,
Thousand Oaks, CA 91320-1799
Made in Japan
(click image for full-size original)

SENSIPAR cinacalcet hydrochloride tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55513-073
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CINACALCET HYDROCHLORIDE (CINACALCET) CINACALCET 30 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE
MAGNESIUM STEARATE
POVIDONE
STARCH, CORN
SILICON DIOXIDE
Product Characteristics
Color GREEN (light green) Score no score
Shape OVAL Size 10mm
Flavor Imprint Code AMG;30
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55513-073-30 30 TABLET, COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021688 04/04/2004
SENSIPAR cinacalcet hydrochloride tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55513-074
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CINACALCET HYDROCHLORIDE (CINACALCET) CINACALCET 60 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE
MAGNESIUM STEARATE
POVIDONE
STARCH, CORN
SILICON DIOXIDE
Product Characteristics
Color GREEN (light green) Score no score
Shape OVAL Size 12mm
Flavor Imprint Code AMG;60
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55513-074-30 30 TABLET, COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021688 04/04/2004
SENSIPAR cinacalcet hydrochloride tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55513-075
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CINACALCET HYDROCHLORIDE (CINACALCET) CINACALCET 90 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE
MAGNESIUM STEARATE
POVIDONE
STARCH, CORN
SILICON DIOXIDE
Product Characteristics
Color GREEN (light green) Score no score
Shape OVAL Size 14mm
Flavor Imprint Code AMG;90
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55513-075-30 30 TABLET, COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021688 04/04/2004
Labeler — Amgen Inc (039976196)
Establishment
Name Address ID/FEI Operations
Patheon Inc. 240769596 ANALYSIS (55513-073), ANALYSIS (55513-074), ANALYSIS (55513-075), LABEL (55513-073), LABEL (55513-074), LABEL (55513-075), MANUFACTURE (55513-073), MANUFACTURE (55513-074), MANUFACTURE (55513-075), PACK (55513-073), PACK (55513-074), PACK (55513-075)

Revised: 12/2019 Amgen Inc

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