Cinacalcet (Page 6 of 6)

16 HOW SUPPLIED/STORAGE AND HANDLING

Cinacalcet tablets, 30 mg are formulated as light-green, oval-shaped, film-coated tablets debossed “C” on one side and “30” on the other side, packaged in bottles of 30 and 500 tablets.

Bottles of 30 NDC 43598-367-30

Bottles of 500 NDC 43598-367-05

Cinacalcet tablets, 60 mg are formulated as light-green, oval-shaped, film-coated tablets debossed “C” on one side and “60” on the other side, packaged in bottles of 30 and 500 tablets.

Bottles of 30 NDC 43598-368-30

Bottles of 500 NDC 43598-368-05

Cinacalcet tablets, 90 mg are formulated as light-green, oval-shaped, film-coated tablets debossed “C” on one side and “90” on the other side, packaged in bottles of 30 and 500 tablets.

Bottles of 30 NDC 43598-369-30

Bottles of 500 NDC 43598-369-05

Storage

Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature].

Dispense in tight, light-resistant container per USP.

17 PATIENT COUNSELING INFORMATION

• Hypocalcemia: Advise patients to report symptoms of hypocalcemia, including paresthesias, myalgias, muscle spasms, and seizures, to their healthcare provider [see Warnings and Precautions (5.1)].
• Upper Gastrointestinal Bleeding: Advise patients to report any symptoms of upper gastrointestinal bleeding to their health care provider [see Warnings and Precautions ( 5.2)].
• Heart Failure: Advise patients with heart failure that use of cinacalcet may worsen their heart failure and additional monitoring may be required [see Warnings and Precautions ( 5.3)].
• Advise patients to report nausea and vomiting to their health care provider [see Adverse Reactions (6.1)].
• Advise patients to take cinacalcet tablets with food or shortly after a meal and to take the tablets whole and not divide them [see Dosage and Administration ( 2.1)].
• Inform patients of the importance of regular blood tests, in order to monitor the safety and efficacy of cinacalcet therapy.

Rx only

Distributer:

Dr. Reddy’s Laboratories Inc.,

Princeton, NJ 08540

Made in India

Revised: 1121

PACKAGE LABEL PRINCIPAL DISPLAY PANEL SECTION

Cinacalcet Tablets 30 mg — 30’s Count

Unvarnished Area consists of: 2D Barcode, Lot Number, Expiry Date and Serial Number.

Cinacalcet Tablets 60 mg — 30’s Count

Unvarnished Area consists of: 2D Barcode, Lot Number, Expiry Date and Serial Number.

Cinacalcet Tablets 90 mg — 30’s Count

Unvarnished Area consists of: 2D Barcode, Lot Number, Expiry Date and Serial Number.

CINACALCET cinacalcet tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43598-367 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 Silicon Dioxide Crospovidone Magnesium Stearate Cellulose, Microcrystalline Povidone Starch, Corn Fd&C Blue No. 2 Hypromelloses Ferric Oxide Yellow Lactose Monohydrate Titanium Dioxide Triacetin

Product Characteristics Color GREEN (light green) Score no score Shape OVAL Size 10mm Flavor Imprint Code C;30 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:43598-367-30 30 TABLET in 1 BOTTLE None 2 NDC:43598-367-05 500 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA208368 09/18/2020

CINACALCET cinacalcet tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43598-368 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 Silicon Dioxide Crospovidone Magnesium Stearate Cellulose, Microcrystalline Povidone Starch, Corn Fd&C Blue No. 2 Hypromelloses Ferric Oxide Yellow Lactose Monohydrate Titanium Dioxide Triacetin

Product Characteristics Color GREEN (light green) Score no score Shape OVAL Size 12mm Flavor Imprint Code C;60 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:43598-368-30 30 TABLET in 1 BOTTLE None 2 NDC:43598-368-05 500 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA208368 09/18/2020

CINACALCET cinacalcet tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43598-369 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 Silicon Dioxide Crospovidone Magnesium Stearate Cellulose, Microcrystalline Povidone Starch, Corn Fd&C Blue No. 2 Hypromelloses Ferric Oxide Yellow Lactose Monohydrate Titanium Dioxide Triacetin

Product Characteristics Color GREEN (light green) Score no score Shape OVAL Size 14mm Flavor Imprint Code C;90 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:43598-369-30 30 TABLET in 1 BOTTLE None 2 NDC:43598-369-05 500 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA208368 09/18/2020

Labeler — Dr. Reddys Laboratories Inc (802315887)

Establishment
Name	Address	ID/FEI	Operations
Dr. Reddys Laboratories Limited (SEZ UNIT)		860037244	analysis (43598-367), manufacture (43598-367), analysis (43598-368), manufacture (43598-368), analysis (43598-369), manufacture (43598-369)

Revised: 11/2021 Dr. Reddys Laboratories Inc