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)

rise35mgblscarton4tabs
(click image for full-size original)

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)

rise75mg2s
(click image for full-size original)

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)

rise150mgblscarton1tab
(click image for full-size original)
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.

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