United States· US:0517-4605_ad03d273-8f44-48f2-bc0e-4dd8dbf08507
Glycopyrrolate
A medicinal product containing glycopyrrolate, registered in United States by American Regent, 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
- GLYCOPYRROLATE
- Manufacturer
- American Regent, 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 6, 2026
Packs & prices · 2
- ndc110517-4605-25
- ndc11051746052525 VIAL, MULTI-DOSE in 1 TRAY (0517-4605-25) / 5 mL in 1 VIAL, MULTI-DOSE
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Glycopyrrolate in 9 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- IrelandGlycopyrronium bromide 200 micrograms/ml Solution for injectionEthypharm
- United KingdomAssicco 1mg tabletsMorningside Healthcare Ltd
- CzechiaAMIDIL AMIHALERZaklady Farmaceutyczne Polpharma SA, Starogard Gdański
- BelgiumAxhidroks 8 mg/gDr. Wolff Arzneimittel
- FinlandAxhidroxDr. August Wolff GmbH & Co. KG Arzneimittel
- CanadaCUVPOSAMEDEXUS PHARMACEUTICALS INC.
- GermanyAxhidroxDr. August Wolff Gmbh & Co. Kg Arzneimittel
- SwedenAxhidrox 2,2 mg/pumpning KrämDr. August Wolff GmbH & Co Arzneimittel
Authorised across Europe · EMA
The same active substance is authorised in 30 EEA countries. Names it is sold under:
- Austria · Axhidrox, Glycopyrroniumbromid Accord
- Belgium · Axhidroks, Robinul
- Bulgaria · Axhidrox, Амидил Амихалер
- Cyprus · Glycopyrronium Bromide Accord, Robinul
- Czechia · Amidil Amihaler, Axhidrox
- Germany · Axhidrox, Glycopyrronium Axiromed
- Denmark · Axhidrox, Glycopirronium Medical Valley
- Estonia · Axhidrox
- Finland · Axhidrox, Glykopyrroniumbromidi Accord
- France · Glycopyrronium Biogaran, Glycopyrronium Wolff
- United Kingdom (Northern Ireland) · Assicco, Glycopyrrolate Mercury Pharmaceuticals
- Greece · Axhidrox, Glycopyrronium Verisfield
- Croatia · Axhidrox
- Hungary · Axhidrox, Rybrila
- Ireland · Axhidrox, Glycopyrronium Bromide Ethypharm
- Iceland · Seebri Breezhaler, Sialanar
- Italy · Axhidrox, Glicopirronio Bromuro Accord
- Liechtenstein · Seebri Breezhaler, Sialanar
- Lithuania · Akshidroz
- Luxembourg · Axhidroks, Robinul
- Latvia · Axhidrox
- Malta · Glycopyrronium Morningside
- Netherlands · Axhidrox, Dusmyla
- Norway · Axhidrox, Glycopirronium Medical Valley
- Poland · Amidil Amihaler, Axhidrox
- Portugal · Glicopirrónio Axidrox
- Romania · Axhidrox
- Sweden · Axhidrox, Glycopirronium Medical Valley
- Slovenia · Axhidrox
- Slovakia · Axhidrox
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/d452f563-cedb-4cdd-b9bb-220b867ba727 GET /v1/drugs/d452f563-cedb-4cdd-b9bb-220b867ba727?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": "INTRAMUSCULAR; INTRAVENOUS",
"source": "ndc",
"strength": ".2",
"substance": "GLYCOPYRROLATE",
"productndc": "0517-4605",
"dosage_form": "INJECTION, SOLUTION",
"dea_schedule": null,
"strength_unit": "mg/mL",
"application_number": "ANDA089335",
"marketing_category": "ANDA"
}See everything about glycopyrrolate.
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.