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United States· US:47335-667_a9910c38-e099-4f8a-a7e9-a88623be2032

risedronate sodium

A medicinal product containing risedronate sodium hemi-pentahydrate, registered in United States by Sun Pharmaceutical Industries, Inc..

US label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedrisedronate sodiumATC—REGISTER NO.US:47335-667_a9910c38…PACKS LISTED8CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
RISEDRONATE SODIUM HEMI-PENTAHYDRATE
Manufacturer
Sun Pharmaceutical Industries, Inc.
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 · 8

  • ndc11
    4733566708
    100 TABLET, FILM COATED in 1 BOTTLE (47335-667-08)
  • ndc11
    4733566718
    1000 TABLET, FILM COATED in 1 BOTTLE (47335-667-18)
  • ndc11
    4733566783
    30 TABLET, FILM COATED in 1 BOTTLE (47335-667-83)
  • ndc11
    4733566788
    100 TABLET, FILM COATED in 1 BOTTLE (47335-667-88)
  • ndc11
    47335-667-08
  • ndc11
    47335-667-18
  • ndc11
    47335-667-83
  • ndc11
    47335-667-88

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Same medicine, other countries

Risedronate sodium hemi-pentahydrate in 1 other country

What each register calls a product with the same active substance — salts and hydrates count as the same.

All risedronate sodium hemi-pentahydrate products

Authorised across Europe · EMA

The same active substance is authorised in 7 EEA countries. Names it is sold under:

  • Cyprus · Atronate
  • Spain · Arisocare, Risedronato Stada
  • France · Risedronate Biogaran, Risedronate Cristers Pharma
  • United Kingdom (Northern Ireland) · Risedronate Sodium
  • Greece · Palibone, Risosfon
  • Italy · Cedravis, Fodren
  • Portugal · Risedronato De Sódio Bluepharma, Risedronato De Sódio Farmoz

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/e751016a-f371-4e6c-8ce0-2905bf912484
GET /v1/drugs/e751016a-f371-4e6c-8ce0-2905bf912484?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": "30",
  "substance": "RISEDRONATE SODIUM HEMI-PENTAHYDRATE",
  "productndc": "47335-667",
  "dosage_form": "TABLET, FILM COATED",
  "dea_schedule": null,
  "strength_unit": "mg/1",
  "application_number": "ANDA090886",
  "marketing_category": "ANDA"
}

See everything about risedronate sodium hemi-pentahydrate.

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.