United States· US:0430-0478_a874a4b5-3deb-40b1-9cb8-d80c3fca4401
Actonel
A medicinal product containing risedronate sodium hemipentahydrate; risedronate sodium monohydrate, registered in United States by Allergan, Inc..
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 HEMIPENTAHYDRATE; RISEDRONATE SODIUM MONOHYDRATE
- Manufacturer
- Allergan, 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 · 2
- ndc1104300478011 TABLET, FILM COATED in 1 DOSE PACK (0430-0478-01)
- ndc110430-0478-01
Regulatory notes
No shortage, Orange Book or US label notes for this record.
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/ec7f2939-da26-430b-9dd2-ce8aa8693310 GET /v1/drugs/ec7f2939-da26-430b-9dd2-ce8aa8693310?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": "129; 21",
"substance": "RISEDRONATE SODIUM HEMIPENTAHYDRATE; RISEDRONATE SODIUM MONOHYDRATE",
"productndc": "0430-0478",
"dosage_form": "TABLET, FILM COATED",
"dea_schedule": null,
"strength_unit": "mg/1; mg/1",
"application_number": "NDA020835",
"marketing_category": "NDA"
}See everything about risedronate sodium hemipentahydrate; risedronate sodium monohydrate.
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.