Provocholine Inhalation Solution

Orange BookUNIISPLATC V04CX03

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

Identification

ManufacturerMethapharm Inc.

CountryUS (United States)

ATC codeV04CX03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6428111612
2 CARTON in 1 CARTON (64281-116-12) / 6 VIAL, PLASTIC in 1 CARTON (64281-116-06) / 3 mL in 1 VIAL, PLASTIC (64281-116-00)

Annotations

UNII (FDA Substance ID)

0W5ETF9M2K

METHACHOLINE CHLORIDE

RxCUI 40165

Orange Book

N019193

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "0W5ETF9M2K",
    "rxcui": "40165",
    "inchikey": "JHPHVAVFUYTVCL-UHFFFAOYSA-M",
    "display_name": "METHACHOLINE CHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "RESPIRATORY (INHALATION)",
  "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": "64281-116_52a662b1-6841-8e8e-e063-6394a90a51e6",
  "productndc": "64281-116",
  "dosage_form": "SOLUTION",
  "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": "METHACHOLINE CHLORIDE",
  "proprietary_name": "Provocholine Inhalation Solution",
  "active_ingred_unit": "mg/3mL",
  "application_number": "NDA019193",
  "marketing_category": "NDA",
  "nonproprietary_name": "Methacholine Chloride Inhalation Solution",
  "start_marketing_date": "20260414",
  "active_numerator_strength": "48"
}

Related drugs

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