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Medicine

Fosamax Plus D 70 mg/2800 IU tablet

Available on requestPrescription onlyUS FDA

Fosamax Plus D 70 mg/2800 IU tablet is a prescription medicine containing Alendronate and Cholecalciferol for oral use, marketed by Organon, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.

Availability

Available on request

Export supply from India to licensed buyers

Typical lead time

On request

Counted from payment and complete documents

Shipping

Ambient

Store at 68°F to 77°F (20°C to 25°C), excursions between 59°F to 86°F (15°C to…

Key facts

Active ingredient (INN)
Alendronate and Cholecalciferol
Brand
Fosamax Plus D
Strength
70 mg/2800 IU
Dosage form
Tablet
Route
Oral
Packs
4 tablets
Marketing authorisation holder
Organon
Manufacturer
Organon
Origin register
US FDA, United States
Storage
Store at 68°F to 77°F (20°C to 25°C), excursions between 59°F to 86°F (15°C to 30°C). are allowed. Protect from moisture and light. Store tablets in the original blister package until use.
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
M05BB03 Alendronic acid and Cholecalciferol
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
1 June 2021
Identifiers
RxCUI 904462, 904465, 904492 +1DailyMed set ID 10307e7e-9a84-4aa1-8c5c-4b209cffe4d1NDC 78206-137Application NDA021762

Record updated 12 November 2026

Documents available

Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.

No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.

Packs

PackCodeLabelerMarketed since
4 tablet in 1 blister pack78206-137-01Organon1 June 2021

Status by register

Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 7 April 2005Drugs@FDA
EU (EMA)Application withdrawnEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Import route

Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.

Import guides are available for 25 countries. Pick one to see its route summary.

BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides

Other strengths and forms of Alendronate and Cholecalciferol

Clinical summary

Alendronate and Cholecalciferol is a fixed-dose combination of a bisphosphonate and a vitamin D indicated for treatment of osteoporosis in postmenopausal women, among other approved uses. It is available as tablets for oral use. MedsAcross supplies Alendronate and Cholecalciferol for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Read about Alendronate and Cholecalciferol

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

Need Fosamax Plus D 70 mg/2800 IU tablet for your hospital or patient?

Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.