United States· US:66794-205_3f1431b2-9fb7-4739-e063-6394a90a1ddc

Glycopyrrolate

A glycopyrronium bromid product containing glycopyrrolate, registered in United States by Piramal Critical Care Inc. The same ATC class is registered in 12 of our 19 countries.

ATC A03AB02Orange BookUS 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…normalisedGlycopyrrolateATCA03AB02REGISTER NO.US:66794-205_3f1431b2…PACKS LISTED1CHECKEDSeptember 12, 2026

Where it is registered

Glycopyrronium bromid is registered in 12 of 19 countries.

Countries holding a registration under ATC A03AB02 (glycopyrronium bromid), each read from that country’s own register.

  • This record: United States, from FDA National Drug Code directory (United States)
  • 7 of them publish a price we can compare per daily dose

Glycopyrronium bromid · ATC A03AB02

12 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Icelandprice
  • Ireland
  • Japan
  • Netherlands
  • Norwayprice
  • Polandprice
  • United Statesprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
Glycopyrrolate
Manufacturer
Piramal Critical Care Inc
Country
United States (US)
ATC code
A03AB02
ATC class
Glycopyrronium bromid
Defined daily dose
3 mg, O
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 12, 2026

Packs & prices · 1

  • ndc11
    6679420541
    10 VIAL, GLASS in 1 CARTON (66794-205-41) / 20 mL in 1 VIAL, GLASS (66794-205-02)

Regulatory notes

UNII (FDA substance ID)
V92SO9WP2I
GLYCOPYRROLATE
RxCUI 4955
Orange Book
A210842
AP
DailyMed SPL labels
1 version tracked

Same medicine, other countries

Glycopyrronium bromid in 9 other countries

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

All glycopyrronium bromid products

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/25480c11-f748-439b-b77a-464d9e2feeb3
GET /v1/drugs/25480c11-f748-439b-b77a-464d9e2feeb3?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.

{
  "unii": {
    "unii": "V92SO9WP2I",
    "rxcui": "4955",
    "inchikey": "VPNYRYCIDCJBOM-QQTWVUFVSA-M;VPNYRYCIDCJBOM-POCMBTLOSA-M",
    "display_name": "GLYCOPYRROLATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR; INTRAVENOUS",
  "livertox": {
    "summary": null,
    "livertox_id": null,
    "hepatotoxicity_score": 5
  },
  "spl_meta": {
    "ec15e70c-8473-469a-9f07-ea668783fa07": {
      "match": "brand_token",
      "title": "GLYCOPYRROLATE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]",
      "spl_version": "9",
      "published_date": "2026-06-01"
    }
  },
  "productid": "66794-205_3f1431b2-9fb7-4739-e063-6394a90a1ddc",
  "productndc": "66794-205",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "210842",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "0.2MG/ML",
        "product_no": "001",
        "approval_date": "Oct 25, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GLYCOPYRROLATE",
  "proprietary_name": "Glycopyrrolate",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA210842",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Glycopyrrolate",
  "start_marketing_date": "20190711",
  "active_numerator_strength": ".2"
}

See everything about glycopyrronium bromid.

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.