Provocholine Inhalation Solution

Orange BookSPL

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerMethapharm Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 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)

Annotations

Orange Book

N019193

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "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
}

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