Alendronate Sodium (Page 8 of 8)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 10 mg (30 Tablets Bottle)

Rx only
NDC 16714-631-01
Alendronate Sodium
Tablets, USP 10 mg*
PHARMACIST: Dispense the accompanying
Medication Guide to each patient.
30 Tablets
Northstar RxTM

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 10 mg (30 Tablets Bottle)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 10 mg Blister Carton (10 x 10 Unit-dose)

Rx only
NDC 16714-631-11
Alendronate Sodium Tablets, USP
10 mg*
PHARMACIST: Dispense the accompanying Medication Guide to each patient.
100 (10 x 10) Unit-dose Tablets
Northstar RxTM

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 10 mg Blister Carton (10 x 10 Unit-dose)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 35 mg Blister Carton (5 Blister of 4 Tablets each)

Rx only
NDC 16714-632-02
ONCE WEEKLY
Alendronate Sodium Tablets, USP
35 mg*
PHARMACIST: Dispense the accompanying Medication Guide to each patient.
20 Tablets (5 Blisters of 4 Tablets each)
Northstar RxTM

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 35 mg Blister Carton (5 Blister of 4 Tablets each)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 70 mg Blister Carton (5 Blister of 4 Tabletseach)

Rx only
NDC 16714-633-02
ONCE WEEKLY
Alendronate Sodium Tablets, USP
70 mg*
PHARMACIST: Dispense the accompanying Medication Guide to each patient.
20 Tablets (5 Blisters of 4 Tablets each)
Northstar RxTM

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 70 mg Blister Carton (5 Blister of 4 Tablets each)
(click image for full-size original)

ALENDRONATE SODIUM alendronate sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-631
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALENDRONATE SODIUM (ALENDRONIC ACID) ALENDRONIC ACID 10 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POVIDONE K30
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color WHITE (White to Off-white) Score no score
Shape ROUND (Biconvex) Size 5mm
Flavor Imprint Code F;18
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-631-01 30 TABLET in 1 BOTTLE None
2 NDC:16714-631-02 100 TABLET in 1 BOTTLE None
3 NDC:16714-631-11 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (16714-631-10)
3 NDC:16714-631-10 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (16714-631-11)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090124 08/04/2008
ALENDRONATE SODIUM alendronate sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-632
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALENDRONATE SODIUM (ALENDRONIC ACID) ALENDRONIC ACID 35 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POVIDONE K30
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color WHITE (White to Off-white) Score no score
Shape OVAL (Biconvex) Size 10mm
Flavor Imprint Code F;19
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-632-01 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 4 TABLET in 1 BLISTER PACK This package is contained within the CARTON (16714-632-01)
2 NDC:16714-632-02 5 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 4 TABLET in 1 BLISTER PACK This package is contained within the CARTON (16714-632-02)
3 NDC:16714-632-11 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (16714-632-10)
3 NDC:16714-632-10 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (16714-632-11)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090124 08/04/2008
ALENDRONATE SODIUM alendronate sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-633
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALENDRONATE SODIUM (ALENDRONIC ACID) ALENDRONIC ACID 70 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POVIDONE K30
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color WHITE (White to Off-white) Score no score
Shape OVAL (Biconvex) Size 13mm
Flavor Imprint Code F;21
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-633-01 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 4 TABLET in 1 BLISTER PACK This package is contained within the CARTON (16714-633-01)
2 NDC:16714-633-02 5 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 4 TABLET in 1 BLISTER PACK This package is contained within the CARTON (16714-633-02)
3 NDC:16714-633-11 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (16714-633-10)
3 NDC:16714-633-10 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (16714-633-11)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090124 08/04/2008
Labeler — NorthStar Rx LLC (830546433)
Registrant — Aurobindo Pharma Limited (650082092)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 918917642 ANALYSIS (16714-631), ANALYSIS (16714-632), ANALYSIS (16714-633), MANUFACTURE (16714-631), MANUFACTURE (16714-632), MANUFACTURE (16714-633)

Revised: 10/2019 NorthStar Rx LLC

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