Risedronate Sodium (Page 9 of 9)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 47335-666-83

Risedronate Sodium Tablets, USP

5 mg

Rx only

30 Tablets

Sun Pharma

PHARMACIST: Please dispense with Medication Guide provided separately to each patient.

spl-risedronate-5mg
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 47335-667-83

Risedronate Sodium Tablets, USP

30 mg

Rx only

30 Tablets

Sun Pharma

PHARMACIST: Please dispense with Medication Guide provided separately to each patient.

spl-risedronate-30mg
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 47335-668-68

Once-a-Week

Risedronate Sodium Tablets, USP

35 mg

4 Week Supply

4 Tablets

Rx only

Sun Pharma

PHARMACIST: Please dispense with Medication Guide provided separately to each patient.

spl-risedronate-35mg
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 47335-727-98

Two Consecutive Days-a-Month

Risedronate Sodium Tablets, USP

75 mg

Rx only

One Month Pack

2 Tablets

Sun Pharma

PHARMACIST: Please dispense with Medication Guide provided separately to each patient.

spl-risedronate-75mg
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 47335-928-60

Once-a-Month

Risedronate Sodium Tablet, USP

150 mg

Rx only

One Month Pack

1 Tablet

Sun Pharma

PHARMACIST: Please dispense with Medication Guide provided separately to each patient.

spl-risedronate-150mg
(click image for full-size original)

RISEDRONATE SODIUM risedronate sodium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:47335-666
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RISEDRONATE SODIUM HEMI-PENTAHYDRATE (RISEDRONIC ACID) RISEDRONATE SODIUM 5 mg
Inactive Ingredients
Ingredient Name Strength
MANNITOL
MICROCRYSTALLINE CELLULOSE
CROSCARMELLOSE
STARCH, CORN
SILICON DIOXIDE
MAGNESIUM STEARATE
POLYVINYL ALCOHOL, UNSPECIFIED
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL, UNSPECIFIED
TALC
FERRIC OXIDE YELLOW
Product Characteristics
Color YELLOW Score no score
Shape ROUND Size 5mm
Flavor Imprint Code S;5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:47335-666-83 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:47335-666-88 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:47335-666-08 100 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:47335-666-18 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090886 11/30/2015
RISEDRONATE SODIUM risedronate sodium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:47335-667
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RISEDRONATE SODIUM HEMI-PENTAHYDRATE (RISEDRONIC ACID) RISEDRONATE SODIUM 30 mg
Inactive Ingredients
Ingredient Name Strength
MANNITOL
MICROCRYSTALLINE CELLULOSE
CROSCARMELLOSE
STARCH, CORN
SILICON DIOXIDE
MAGNESIUM STEARATE
POLYVINYL ALCOHOL, UNSPECIFIED
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL, UNSPECIFIED
TALC
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 10mm
Flavor Imprint Code S;667
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:47335-667-83 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:47335-667-88 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:47335-667-08 100 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:47335-667-18 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090886 11/30/2015
RISEDRONATE SODIUM risedronate sodium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:47335-668
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RISEDRONATE SODIUM HEMI-PENTAHYDRATE (RISEDRONIC ACID) RISEDRONATE SODIUM 35 mg
Inactive Ingredients
Ingredient Name Strength
MANNITOL
MICROCRYSTALLINE CELLULOSE
CROSCARMELLOSE
STARCH, CORN
SILICON DIOXIDE
MAGNESIUM STEARATE
POLYVINYL ALCOHOL, UNSPECIFIED
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL, UNSPECIFIED
TALC
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
Product Characteristics
Color BROWN Score no score
Shape ROUND Size 11mm
Flavor Imprint Code S;668
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:47335-668-68 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 (47335-668-68)
2 NDC:47335-668-62 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 (47335-668-62)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090886 11/30/2015
RISEDRONATE SODIUM risedronate sodium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:47335-727
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RISEDRONATE SODIUM HEMI-PENTAHYDRATE (RISEDRONIC ACID) RISEDRONATE SODIUM 75 mg
Inactive Ingredients
Ingredient Name Strength
MANNITOL
MICROCRYSTALLINE CELLULOSE
CROSCARMELLOSE
STARCH, CORN
SILICON DIOXIDE
MAGNESIUM STEARATE
POLYVINYL ALCOHOL, UNSPECIFIED
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL, UNSPECIFIED
TALC
FERRIC OXIDE RED
Product Characteristics
Color PINK Score no score
Shape ROUND Size 9mm
Flavor Imprint Code S;727
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:47335-727-98 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 (47335-727-98)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090886 06/11/2014
RISEDRONATE SODIUM risedronate sodium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:47335-928
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RISEDRONATE SODIUM HEMI-PENTAHYDRATE (RISEDRONIC ACID) RISEDRONATE SODIUM 150 mg
Inactive Ingredients
Ingredient Name Strength
MANNITOL
MICROCRYSTALLINE CELLULOSE
CROSCARMELLOSE
STARCH, CORN
SILICON DIOXIDE
MAGNESIUM STEARATE
POLYVINYL ALCOHOL, UNSPECIFIED
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL, UNSPECIFIED
TALC
FD&C BLUE NO. 2
Product Characteristics
Color BLUE Score no score
Shape ROUND Size 10mm
Flavor Imprint Code S;928
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:47335-928-60 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 (47335-928-60)
2 NDC:47335-928-67 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (47335-928-67)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090886 06/11/2014
Labeler — Sun Pharmaceutical Industries, Inc. (146974886)
Establishment
Name Address ID/FEI Operations
Sun Pharmaceutical Industries Limited 650445203 ANALYSIS (47335-666), ANALYSIS (47335-667), ANALYSIS (47335-668), ANALYSIS (47335-727), ANALYSIS (47335-928), MANUFACTURE (47335-666), MANUFACTURE (47335-667), MANUFACTURE (47335-668), MANUFACTURE (47335-727), MANUFACTURE (47335-928)

Revised: 08/2020 Sun Pharmaceutical Industries, Inc.

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