Risedronate Sodium (Page 9 of 9)

PACKAGE LABEL — PRINCIPAL DISPLAY PANEL — 35 MG CARTON

APOTEX CORP. NDC 60505-3165-0

Risedronate Sodium Tablets, USP 35 mg

Each film-coated tablet contains 40.5 mg of risedronate sodium hemipentahydrate (equivalent to 35 mg of risedronate sodium).

35 mg

Rx only

4 Tablets (Once-a-Week)

PACKAGE LABEL — PRINCIPAL DISPLAY PANEL — 75 MG CARTON

APOTEX CORP. NDC 60505-3096-2

Risedronate Sodium Tablets, USP 75 mg

Each film-coated tablet contains 86.7 mg of risedronate sodium hemipentahydrate (equivalent to 75 mg of risedronate sodium).

75 mg

Rx only

2 Tablets (Two Consecutive Days-a-Month)

PACKAGE LABEL — PRINCIPAL DISPLAY PANEL — 150 MG CARTON

APOTEX CORP. NDC 60505-3097-2

Risedronate Sodium Tablet, USP 150 mg

Each film-coated tablet contains 173.4 mg of risedronate sodium hemipentahydrate (equivalent to 150 mg of risedronate sodium).

150 mg

Rx only

1 Tablet (Once-a-Month)

RISEDRONATE SODIUM risedronate sodium tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60505-3165 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RISEDRONATE SODIUM (RISEDRONIC ACID) RISEDRONATE SODIUM 35 mg

Inactive Ingredients Ingredient Name Strength CROSPOVIDONE (15 MPA.S AT 5%) FERRIC OXIDE RED FERRIC OXIDE YELLOW HYDROXYPROPYL CELLULOSE (1600000 WAMW) HYPROMELLOSES MAGNESIUM STEARATE POLYETHYLENE GLYCOL 8000 TITANIUM DIOXIDE ANHYDROUS LACTOSE SILICON DIOXIDE

Product Characteristics Color ORANGE Score no score Shape ROUND (Biconvex) Size 7mm Flavor Imprint Code APO;RIS;35 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:60505-3165-0 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK 1 4 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (60505-3165-0) 2 NDC:60505-3165-2 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK 2 4 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (60505-3165-2)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090877 11/30/2015

RISEDRONATE SODIUM risedronate sodium tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60505-3096 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RISEDRONATE SODIUM (RISEDRONIC ACID) RISEDRONATE SODIUM 75 mg

Inactive Ingredients Ingredient Name Strength CROSPOVIDONE (15 MPA.S AT 5%) FERRIC OXIDE RED HYDROXYPROPYL CELLULOSE (1600000 WAMW) HYPROMELLOSES MAGNESIUM STEARATE POLYETHYLENE GLYCOL 8000 TITANIUM DIOXIDE ANHYDROUS LACTOSE SILICON DIOXIDE

Product Characteristics Color PINK (dark) Score no score Shape ROUND (biconvex) Size 9mm Flavor Imprint Code APO;RIS;75 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:60505-3096-2 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK 1 2 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (60505-3096-2)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090877 06/11/2014

RISEDRONATE SODIUM risedronate sodium tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60505-3097 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RISEDRONATE SODIUM (RISEDRONIC ACID) RISEDRONATE SODIUM 150 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE CROSPOVIDONE (15 MPA.S AT 5%) MAGNESIUM STEARATE SILICON DIOXIDE HYPROMELLOSES HYDROXYPROPYL CELLULOSE (1600000 WAMW) POLYETHYLENE GLYCOL 8000 TITANIUM DIOXIDE FD&C BLUE NO. 2 SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE SODIUM PHOSPHATE, DIBASIC

Product Characteristics Color BLUE Score no score Shape ROUND (biconvex) Size 9mm Flavor Imprint Code APO;RIS;150 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:60505-3097-2 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK 1 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (60505-3097-2) 2 NDC:60505-3097-4 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK 2 3 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (60505-3097-4)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090877 06/11/2014

Labeler — Apotex Corp. (845263701)

Registrant — Apotex Inc. (209429182)

Establishment
Name	Address	ID/FEI	Operations
Apotex Inc.		209429182	analysis (60505-3165), analysis (60505-3096), analysis (60505-3097), manufacture (60505-3165), manufacture (60505-3096), manufacture (60505-3097)

Revised: 01/2020 Apotex Corp.