United States· US:0115-1676_0bb7b70c-72e0-4bb8-9d3a-0fc8e4762dd1
Alendronate Sodium
A medicinal product containing alendronate sodium, registered in United States by Amneal Pharmaceuticals of New York LLC.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- ALENDRONATE SODIUM
- Manufacturer
- Amneal Pharmaceuticals of New York LLC
- Country
- United States (US)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 4
- ndc110115167601100 TABLET in 1 BOTTLE (0115-1676-01)
- ndc11011516760830 TABLET in 1 BOTTLE (0115-1676-08)
- ndc110115-1676-01
- ndc110115-1676-08
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Alendronate sodium in 8 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- FinlandFosamax MiteMerck Sharp & Dohme B.V.
- BelgiumAlendromono 70 mgTakeda Belgium
- CzechiaALENDROGENVIATRIS LIMITED, Dublin
- GermanyAlendronsäure 1 A Pharma1 A Pharma Gmbh
- SwedenAlendronat Aurobindo Veckotablett 70 mg TablettAurobindo Pharma (Malta) Limited
- NorwayAlendronat BluefishBluefish Pharmaceuticals AB
- IrelandAlendronic Acid Bluefish Once weekly 70 mg tabletsBluefish Pharmaceuticals AB
- IcelandAlendronat BluefishBluefish Pharmaceuticals AB
Authorised across Europe · EMA
The same active substance is authorised in 22 EEA countries. Names it is sold under:
- Austria · Alendronsäure Bluefish
- Cyprus · Alendronic Acid Aurobindo, Binosto
- Germany · Alendronsäure 1 A Pharma, Alendronsäure Aurobindo
- Denmark · Alendronat Aurobindo, Alendronat Bluefish
- Spain · Ácido Alendrónico Ortodrol, Ácido Alendrónico Qualigen
- Finland · Alendronat Ratiopharm, Alensol
- France · Acide Alendronique Alter, Acide Alendronique Arrow Lab
- United Kingdom (Northern Ireland) · Alendronic Acid, Alendronic Acid Generics Uk
- Greece · Ampine, Arthroplus
- Croatia · Forosa
- Hungary · Elanosta
- Ireland · Alendronic Acid Once Weekly Bluefish, Binosto Once Weekly
- Iceland · Alendronat Bluefish
- Italy · Acido Alendronico Alter, Acido Alendronico Aurobindo
- Lithuania · Ostemax
- Malta · Alendronic Acid Aurobindo Pharma (Malta), Binosto
- Netherlands · Alendronate Sodium Trihydrate Aurobindo, Bonasol Eenmaal Per Week
- Norway · Alendronat Bluefish, Alensol
- Poland · Alendronat Bluefish, Ostemax Comfort
- Portugal · Ácido Alendrónico Azevedos, Ácido Alendrónico Beapy
- Romania · Binosto
- Sweden · Alendronat Aurobindo, Alendronat Bluefish
Source: European Medicines Agency, Article 57 product data.
Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.
For developers
The same record over the API, and the raw payload
GET /v1/drugs/46c2e923-3f3c-46c3-849e-551216738bc8 GET /v1/drugs/46c2e923-3f3c-46c3-849e-551216738bc8?format=fhir
Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.
{
"route": "ORAL",
"source": "ndc",
"strength": "5",
"substance": "ALENDRONATE SODIUM",
"productndc": "0115-1676",
"dosage_form": "TABLET",
"dea_schedule": null,
"strength_unit": "mg/1",
"application_number": "ANDA075710",
"marketing_category": "ANDA"
}See everything about alendronate sodium.
This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.