FOSAMAX (Page 8 of 8)

Distributed by: Organon LLC, a subsidiary of
ORGANON & Co.,
Jersey City, NJ 07302, USA

For patent information: www.organon.com/our-solutions/patent/

Copyright © 2021 Organon Global Inc.
All rights reserved.

Revised: 6/2021

usmg-og0217-mf-2106r000

This Medication Guide has been approved by the U.S. Food and Drug Administration.

PRINCIPAL DISPLAY PANEL — 4 Tablet Blister Pack

ONCE WEEKLY
FOSAMAX® 70 mg
(Alendronate SodiumTablets)

Dispense the enclosed
Medication Guide
to each patient.

Each tablet contains
91.37 mg
alendronate sodium
(70 mg free acid
equivalent)

4 Tablets

Rx only

USUAL ADULT
DOSAGE:
ONE 70 mg TABLET
ONCE WEEKLY

See accompanying
circular for complete
dosage information.

Dist. by:
Organon LLC, a subsidiary of
ORGANON & Co.,
Jersey City, NJ 07302, USA

Manuf. by:
Aesica Pharmaceuticals GmbH
Galileistraβe 6, 08056 Zwickau, Germany

Alendronate Sodium(active ingred.) Made in Ireland.

Formulated in Germany.

Copyright © 2021 Organon Global Inc. All rights reserved.

PRINCIPAL DISPLAY PANEL -- 4 Tablet Blister Pack
(click image for full-size original)
FOSAMAX alendronate sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:78206-135
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
MICROCRYSTALLINE CELLULOSE
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:78206-135-01 4 TABLET in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020560 06/01/2021
Labeler — Organon LLC (117494753)

Revised: 06/2022 Organon LLC

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