Fosamax (Page 5 of 5)

PRINCIPAL DISPLAY PANEL

FOSAMAX, Tablets, 5 mgimage of 5 mg package label

FOSAMAX, Tablets, 10 mgimage of 10 mg package label

FOSAMAX, Tablets, 35 mgimage of 35 mg package label

FOSAMAX, Tablets, 70 mgimage of 70 mg package label

FOSAMAX alendronate sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-4384(NDC:0006-0925)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALENDRONATE SODIUM (ALENDRONIC ACID) ALENDRONATE SODIUM 5 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
ANHYDROUS LACTOSE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
Product Characteristics
Color white (white) Score no score
Shape ROUND (round) Size 8mm
Flavor Imprint Code MRK;925
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-4384-0 30 TABLET (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020560 11/20/2000
FOSAMAX alendronate sodium tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-3857(NDC:0006-0936)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALENDRONATE SODIUM (ALENDRONIC ACID) ALENDRONATE SODIUM 10 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
ANHYDROUS LACTOSE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
CARNAUBA WAX
Product Characteristics
Color white (white) Score no score
Shape OVAL (oval) Size 11mm
Flavor Imprint Code MRK;936
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-3857-0 30 TABLET, COATED (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020560 12/19/1996
FOSAMAX alendronate sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-4463(NDC:0006-0077)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALENDRONATE SODIUM (ALENDRONIC ACID) ALENDRONATE SODIUM 35 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
ANHYDROUS LACTOSE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
Product Characteristics
Color white (white) Score no score
Shape OVAL (oval) Size 10mm
Flavor Imprint Code 77
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-4463-0 04 TABLET (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020560 02/05/2001
FOSAMAX alendronate sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-4462(NDC:0006-0031)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALENDRONATE SODIUM (ALENDRONIC ACID) ALENDRONATE SODIUM 70 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
ANHYDROUS LACTOSE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
Product Characteristics
Color white (white) Score no score
Shape OVAL (oval) Size 13mm
Flavor Imprint Code 31
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-4462-0 04 TABLET (TABLET) in 1 BOTTLE None
2 NDC:54868-4462-1 12 TABLET (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020560 02/17/2010
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 repack, relabel

Revised: 03/2010 Physicians Total Care, Inc.

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