United States· US:65862-519_9488209f-f3ad-4726-be89-f6a7e59e6885
Risedronate Sodium
A medicinal product containing risedronate sodium, registered in United States by Aurobindo Pharma Limited.
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
- RISEDRONATE SODIUM
- Manufacturer
- Aurobindo Pharma Limited
- 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
- ndc1165862-519-04
- ndc1165862-519-08
- ndc1165862519041 BLISTER PACK in 1 CARTON (65862-519-04) / 4 TABLET, FILM COATED in 1 BLISTER PACK
- ndc1165862519083 BLISTER PACK in 1 CARTON (65862-519-08) / 4 TABLET, FILM COATED in 1 BLISTER PACK
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Risedronate sodium in 7 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaRISEDRONAT TEVATeva Pharmaceuticals CR, s.r.o., Praha
- FinlandCladronateActavis Group PTC ehf
- SwedenAvestra Septimum 35 mg Filmdragerad tablettTheramex Ireland Limited
- IrelandRidate Once a Week 35mg film-coated tabletsRowex Limited,
- NorwayOptinate SeptimumOrifarm AS
- United KingdomActonel 30mg tabletsWarner Chilcott UK Ltd
- GermanyAcaraAnwerina Deutschland Gmbh
Authorised across Europe · EMA
The same active substance is authorised in 29 EEA countries. Names it is sold under:
- Austria · Actonel Einmal Wöchentlich, Risedronat Einmal Wöchentlich Stada
- Belgium · Actonel, Actonel Hebdomadaire
- Bulgaria · Зилар, Ризида
- Cyprus · Actonel «2 Συνεχόμενεσ Ημέρεσ Το Μήνα», Actonel Oaw/«μία Φορά Την Εβδομάδα»
- Czechia · Risedronat Teva, Risendros
- Germany · Acara, Actonel
- Denmark · Karadronat, Optinate Septimum
- Estonia · Norifaz
- Spain · Acrel Semanal, Actonel
- Finland · Optinate Septimum, Risedronat Sandoz
- France · Actonel, Risedronat Viatris
- United Kingdom (Northern Ireland) · Actonel Once A Week, Risedronate Sodium Accord-Uk
- Greece · Actonel, Actonel Gr
- Croatia · Actonel, Bonna
- Hungary · Actonel, Boneact
- Ireland · Ridate Once A Week, Risedronate Once A Week Bluefish
- Iceland · Risedronate Bluefish
- Italy · Actonel, Optinate
- Lithuania · Norifaz, Risendros
- Luxembourg · Actonel, Actonel Hebdomadaire
- Latvia · Norifaz, Risendros
- Malta · Risedronate Aurobindo, Risedronate Once A Week Aurobindo
- Netherlands · Actonel, Actonel Wekelijks
- Poland · Norifaz, Risendros 35
- Portugal · Actonel, Risedronato De Sódio Alter
- Romania · Actonel, Risedronat Arena
- Sweden · Avestra, Avestra Septimum
- Slovenia · Actonel
- Slovakia · Risendros
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/b5cc7067-8e5a-42f5-b9a1-6ceb7c004fc4 GET /v1/drugs/b5cc7067-8e5a-42f5-b9a1-6ceb7c004fc4?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": "35",
"substance": "RISEDRONATE SODIUM",
"productndc": "65862-519",
"dosage_form": "TABLET, FILM COATED",
"dea_schedule": null,
"strength_unit": "mg/1",
"application_number": "ANDA200296",
"marketing_category": "ANDA"
}See everything about risedronate 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.