United States· US:65649-551_9db15b8c-2928-4b75-a33b-548416afc8c9
Relistor
A medicinal product containing methylnaltrexone bromide, registered in United States by Salix Pharmaceuticals, 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
- METHYLNALTREXONE BROMIDE
- Manufacturer
- Salix Pharmaceuticals, 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 · 6
- ndc1165649551021 VIAL, SINGLE-DOSE in 1 CARTON (65649-551-02) / .6 mL in 1 VIAL, SINGLE-DOSE
- ndc1165649551037 BLISTER PACK in 1 CARTON (65649-551-03) / 1 SYRINGE in 1 BLISTER PACK / .6 mL in 1 SYRINGE
- ndc1165649551071 BLISTER PACK in 1 CARTON (65649-551-07) / 1 SYRINGE in 1 BLISTER PACK / .6 mL in 1 SYRINGE
- ndc1165649-551-02
- ndc1165649-551-03
- ndc1165649-551-07
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Methylnaltrexone bromide in 14 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- IrelandRELISTOR 12 mg/0.6 mL solution for injectionBausch Health Ireland Limited
- CzechiaRELISTORBausch Health Ireland Limited, Dublin
- BelgiumRelistor 12 mgBausch Health Ireland
- FinlandRelistorBausch Health Ireland Limited
- PolandRelistorBausch Health Ireland Ltd.
- SwedenRelistor 12 mg Injektionsvätska, lösning i förfylld sprutaBausch Health Ireland Ltd
- SwitzerlandRelistor, InjektionslösungCuratis AG
- SpainRELISTOR 12 mg/0,6 ml, SOLUCION INYECTABLEBausch Health Ireland Limited
Authorised across Europe · EMA
The same active substance is authorised in 4 EEA countries. Names it is sold under:
- United Kingdom (Northern Ireland) · Relistor
- Iceland · Relistor
- Liechtenstein · Relistor
- Norway · Relistor
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/108b3106-0bb9-4b5a-b0cd-fc0c9b2b619f GET /v1/drugs/108b3106-0bb9-4b5a-b0cd-fc0c9b2b619f?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": "SUBCUTANEOUS",
"source": "ndc",
"strength": "12",
"substance": "METHYLNALTREXONE BROMIDE",
"productndc": "65649-551",
"dosage_form": "INJECTION, SOLUTION",
"dea_schedule": null,
"strength_unit": "mg/.6mL",
"application_number": "NDA021964",
"marketing_category": "NDA"
}See everything about methylnaltrexone bromide.
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.