Back to search

United States· US:64281-110_52a662b1-6841-8e8e-e063-6394a90a51e6

Provocholine Inhalation Solution

A medicinal product containing methacholine chloride inhalation solution, registered in United States by Methapharm Inc..

Orange 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…normalisedProvocholine Inhalation SolutionATC—REGISTER NO.US:64281-110_52a662b1…PACKS LISTED1CHECKEDJune 3, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
Methacholine Chloride Inhalation Solution
Manufacturer
Methapharm Inc.
Country
United States (US)
ATC code
—
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
June 3, 2026

Packs & prices · 1

  • ndc11
    6428111006
    6 PACKAGE in 1 PACKAGE (64281-110-06) / 6 CARTON in 1 PACKAGE (64281-110-05) / 1 KIT in 1 CARTON * 1 VIAL, PLASTIC in 1 KIT / 3 mL in 1 VIAL, PLASTIC (64281-113-00) * 1 VIAL, PLASTIC in 1 KIT / 3 mL in 1 VIAL, PLASTIC (64281-115-00) * 1 VIAL, PLASTIC in 1 KIT / 3 mL in 1 VIAL, PLASTIC (64281-114-00) * 1 VIAL, PLASTIC in 1 KIT / 3 mL in 1 VIAL, PLASTIC (64281-116-00) * 1 VIAL, PLASTIC in 1 KIT / 3 mL in 1 VIAL, PLASTIC (64281-112-00) * 1 VIAL, PLASTIC in 1 KIT / 3 mL in 1 VIAL, PLASTIC (64281-111-00)

Regulatory notes

Orange Book
N019193
DailyMed SPL labels
1 version tracked

Same medicine, other countries

Methacholine chloride inhalation solution in 10 other countries

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

All methacholine chloride inhalation solution products

Authorised across Europe · EMA

The same active substance is authorised in 9 EEA countries. Names it is sold under:

  • Germany · Provokit
  • Denmark · Provocholine
  • Spain · Provocholine
  • France · Chlorure De Methacholine Panpharma
  • Ireland · Methacholine Chloride Methapharm
  • Italy · Metacolina Lofarma
  • Netherlands · Provocholine
  • Norway · Provocholine
  • Sweden · Provocholine

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/91473bf8-8623-467e-80c4-dcaeeae5e215
GET /v1/drugs/91473bf8-8623-467e-80c4-dcaeeae5e215?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": null,
  "spl_meta": {
    "e8983096-65e6-41f2-8b6f-bbf0a7227307": {
      "match": "brand_token",
      "title": "PROVOCHOLINE (METHACHOLINE CHLORIDE) POWDER, FOR SOLUTION PROVOCHOLINE INHALATION SOLUTION (METHACHOLINE CHLORIDE INHALATION SOLUTION) SOLUTION PROVOCHOLINE INHALATION SOLUTION (METHACHOLINE CHLORIDE INHALATION SOLUTION) KIT [METHAPHARM INC.]",
      "spl_version": "27",
      "published_date": "2026-05-27"
    }
  },
  "productid": "64281-110_52a662b1-6841-8e8e-e063-6394a90a51e6",
  "productndc": "64281-110",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "019193",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "100MG/VIAL",
        "product_no": "001",
        "approval_date": "Oct 31, 1986"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "1600MG/VIAL",
        "product_no": "002",
        "approval_date": "Aug 29, 2016"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Provocholine Inhalation Solution",
  "active_ingred_unit": null,
  "application_number": "NDA019193",
  "marketing_category": "NDA",
  "nonproprietary_name": "Methacholine Chloride Inhalation Solution",
  "start_marketing_date": "20220303",
  "active_numerator_strength": null
}

See everything about methacholine chloride inhalation solution.

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.