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United States· US:0115-2622_63142944-3083-4d47-908f-2984144b6c5d

TERBUTALINE SULFATE

A medicinal product containing terbutaline sulfate, registered in United States by Amneal Pharmaceuticals of New York LLC.

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…normalisedTERBUTALINE SULFATEATC—REGISTER NO.US:0115-2622_63142944…PACKS LISTED4CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
TERBUTALINE SULFATE
Manufacturer
Amneal Pharmaceuticals of New York LLC
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 · 4

  • ndc11
    0115262201
    100 TABLET in 1 BOTTLE (0115-2622-01)
  • ndc11
    0115262202
    500 TABLET in 1 BOTTLE (0115-2622-02)
  • ndc11
    0115-2622-01
  • ndc11
    0115-2622-02

Regulatory notes

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

Same medicine, other countries

Terbutaline sulfate in 13 other countries

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

All terbutaline sulfate products

Authorised across Europe · EMA

The same active substance is authorised in 17 EEA countries. Names it is sold under:

  • Austria · Bricanyl
  • Cyprus · Ataline
  • Czechia · Bricanyl
  • Germany · Aerodur Turbohaler, Bricanyl
  • Denmark · Bricanyl Turbuhaler
  • Spain · Terbasmin, Terbasmin Turbuhaler
  • Finland · Bricanyl Turbuhaler
  • France · Bricanyl, Bricanyl Turbuhaler
  • United Kingdom (Northern Ireland) · Bricanyl, Bricanyl Respules
  • Hungary · Bricanyl
  • Ireland · Bricanyl, Bricanyl Turbohaler
  • Iceland · Bricanyl Turbuhaler
  • Malta · Bricanyl Turbohaler
  • Netherlands · Bricanyl Turbuhaler
  • Norway · Bricanyl, Bricanyl Turbuhaler
  • Portugal · Bricanyl Turbohaler
  • Sweden · Bricanyl, Bricanyl Turbuhaler

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/d46ca2bc-346f-4e49-a85f-521a22b9262c
GET /v1/drugs/d46ca2bc-346f-4e49-a85f-521a22b9262c?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": "5",
  "substance": "TERBUTALINE SULFATE",
  "productndc": "0115-2622",
  "dosage_form": "TABLET",
  "dea_schedule": null,
  "strength_unit": "mg/1",
  "application_number": "ANDA075877",
  "marketing_category": "ANDA"
}

See everything about terbutaline sulfate.

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.