Risedronate Sodium (Page 9 of 9)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 150 mg Blister Card (1 Unit-of-use)

NDC 65862-870-11
Rx only
Once-a-Month
Risedronate Sodium
Tablet, USP 150 mg AUROBINDO One-Month Supply (1 Tablet)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 150 mg Blister Card (1 Unit-of-use)
(click image for full-size original)


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 150 mg Blister Card (1 Unit-of-use)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 150 mg Blister Carton (1 Unit-of-use)

NDC 65862-870-11
Rx only
Once-a-Month
Risedronate Sodium
Tablet, USP
150 mg
PHARMACIST: Dispense the accompanying Medication Guide to each patient.
AUROBINDO One-Month Supply (1 Tablet)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 150 mg Blister Carton (1 Unit-of-use)
(click image for full-size original)

RISEDRONATE SODIUM risedronate sodium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-870
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
SILICON DIOXIDE
CROSPOVIDONE (120 .MU.M)
FD&C BLUE NO. 2
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE 2910 (6 MPA.S)
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL 400
POLYETHYLENE GLYCOL 8000
TITANIUM DIOXIDE
Product Characteristics
Color BLUE Score no score
Shape ROUND (Biconvex) Size 9mm
Flavor Imprint Code Z;43
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65862-870-11 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 (65862-870-11)
2 NDC:65862-870-03 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 (65862-870-03)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206768 10/21/2016
Labeler — Aurobindo Pharma Limited (650082092)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 918917642 ANALYSIS (65862-870), MANUFACTURE (65862-870)

Revised: 07/2022 Aurobindo Pharma Limited

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