Provocholine
Approved
Approval ID
e8983096-65e6-41f2-8b6f-bbf0a7227307
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 14, 2023
Manufacturers
FDA
Methapharm Inc.
DUNS: 253526222
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
methacholine chloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64281-100
Application NumberNDA019193
Product Classification
M
Marketing Category
C73594
G
Generic Name
methacholine chloride
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateJuly 14, 2022
FDA Product Classification
INGREDIENTS (1)
METHACHOLINE CHLORIDEActive
Quantity: 100 mg in 100 mg
Code: 0W5ETF9M2K
Classification: ACTIM
Methacholine Chloride Inhalation Solution
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64281-110
Application NumberNDA019193
Product Classification
M
Marketing Category
C73594
G
Generic Name
Methacholine Chloride Inhalation Solution
Product Specifications
Effective DateJuly 14, 2022
FDA Product Classification