NDC Code(s) : 0591-3169-30, 0591-3170-30, 0591-3171-04, 0591-3172-30, 0591-3173-04
Packager : Actavis Pharma, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Alendronate SodiumAlendronate Sodium TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-3169
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALENDRONATE SODIUM(UNII: 2UY4M2U3RA)
(ALENDRONIC ACID - UNII:X1J18R4W8P) 		ALENDRONIC ACID5 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
STARCH, CORN(UNII: O8232NY3SJ)
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 8 mm
Flavor Imprint Code WPI;3169
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0591-3169-3030 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product08/04/2008
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076768 08/04/2008
Alendronate SodiumAlendronate Sodium TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-3170
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALENDRONATE SODIUM(UNII: 2UY4M2U3RA)
(ALENDRONIC ACID - UNII:X1J18R4W8P) 		ALENDRONIC ACID10 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
STARCH, CORN(UNII: O8232NY3SJ)
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 9 mm
Flavor Imprint Code WPI;3170
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0591-3170-3030 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product08/04/2008
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076768 08/04/2008
Alendronate SodiumAlendronate Sodium TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-3171
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALENDRONATE SODIUM(UNII: 2UY4M2U3RA)
(ALENDRONIC ACID - UNII:X1J18R4W8P) 		ALENDRONIC ACID35 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
STARCH, CORN(UNII: O8232NY3SJ)
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 10 mm
Flavor Imprint Code WPI;3171
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0591-3171-044 in 1 BLISTER PACK Type 0: Not a Combination Product08/04/2008
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076768 08/04/2008
Alendronate SodiumAlendronate Sodium TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-3172
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALENDRONATE SODIUM(UNII: 2UY4M2U3RA)
(ALENDRONIC ACID - UNII:X1J18R4W8P) 		ALENDRONIC ACID40 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
STARCH, CORN(UNII: O8232NY3SJ)
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 8 mm
Flavor Imprint Code WPI;3172
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0591-3172-3030 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product08/04/2008
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076768 08/04/2008
Alendronate SodiumAlendronate Sodium TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-3173
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALENDRONATE SODIUM(UNII: 2UY4M2U3RA)
(ALENDRONIC ACID - UNII:X1J18R4W8P) 		ALENDRONIC ACID70 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
STARCH, CORN(UNII: O8232NY3SJ)
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 13 mm
Flavor Imprint Code WPI;3173
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0591-3173-044 in 1 BLISTER PACK Type 0: Not a Combination Product08/04/2008
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076768 08/04/2008

PRINCIPAL DISPLAY PANEL

NDC 0591-3169-30
Alendronate Sodium Tablets USP
5 mg*
Watson® Rx only 30 Tablets

NDC 0591-3169-30 Alendronate Sodium Tablets USP 5 mg* Watson® Rx only 30 Tablets

PRINCIPAL DISPLAY PANEL

NDC 0591-3170-30
Alendronate Sodium Tablets USP 10 mg*
Watson® Rx only 30 Tablets

NDC 0591-3170-30 Alendronate Sodium Tablets USP 10 mg* Watson® Rx only 30 Tablets

PRINCIPAL DISPLAY PANEL

NDC 0591-3171-04
For the prevention of osteoporosis in postmenopausal women
Once Weekly
Alendronate Sodium Tablets USP 35 mg*
Watson® Rx only 4 Tablets

NDC 0591-3171-04 Once Weekly Alendronate Sodium Tablets USP 35 mg* Watson® Rx only 4 Tablets

PRINCIPAL DISPLAY PANEL

NDC 0591-3172-30
Alendronate Sodium Tablets USP
40 mg*
Watson® Rx only 30 Tablets

NDC 0591-3172-30 Alendronate Sodium Tablets USP 40 mg* Watson® Rx only 30 Tablets

PRINCIPAL DISPLAY PANEL

NDC 0591-3173-04
For the treatment of osteoporosis in postmenopausal women
Once Weekly
Alendronate Sodium Tablets USP 70 mg*
Watson® Rx only 4 Tablets

NDC 0591-3173-04 Once Weekly Alendronate Sodium Tablets USP 70 mg* Watson® Rx only 4 Tablets