1. Home
  2. Labeler Index
  3. Methapharm, Inc.
  4. NDC Product Code: 67850-552 Aridol Bronchial Challenge Test Kit

NDC 67850-552 Aridol Bronchial Challenge Test Kit

Mannitol Kit - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 67850-552?
  5. Aridol Bronchial Challenge Test Kit Uses
  6. Active Ingredients UNII Codes

Product Information

NDC Product Code:
67850-552
Proprietary Name:
Aridol Bronchial Challenge Test Kit
Non-Proprietary Name: [1]
Mannitol
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Kit - A packaged collection of related material.
Labeler Name: [5]
Methapharm, Inc.
Labeler Code:
67850
Product Label ID:
5387a4fb-b894-4cba-88a3-a947217d34da
FDA Application Number: [6]
NDA022368
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date: [9]
10-05-2010
Listing Expiration Date: [11]
12-31-2024
Exclude Flag: [12]
N
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325 - WHITE/CLEAR)
YELLOW (C48330 - YELLOW/CLEAR)
PINK (C48328 - PINK/CLEAR)
RED (C48326 - RED/CLEAR)
WHITE (C48325)
Shape:
CAPSULE (C48336)
Size(s):
15 MM
Imprint(s):
5;MG
10;MG
20;MG
40;MG
Score:
1

Product Packages

NDC Code 67850-552-01

Package Description: 1 KIT in 1 KIT * 1 POWDER in 1 CAPSULE * 1 POWDER in 1 KIT * 1 POWDER in 1 KIT * 1 POWDER in 1 KIT

Product Details

What is NDC 67850-552?

The NDC code 67850-552 is assigned by the FDA to the product Aridol Bronchial Challenge Test Kit which is a human prescription drug product labeled by Methapharm, Inc.. The generic name of Aridol Bronchial Challenge Test Kit is mannitol. The product's dosage form is kit. The product is distributed in a single package with assigned NDC code 67850-552-01 1 kit in 1 kit * 1 powder in 1 capsule * 1 powder in 1 kit * 1 powder in 1 kit * 1 powder in 1 kit. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Aridol Bronchial Challenge Test Kit?

Mannitol, the active ingredient in ARIDOL, is a sugar alcohol indicated for the assessment of bronchial hyperresponsiveness in patients 6 years of age or older who do not have clinically apparent asthma.Limitations of Use:ARIDOL is not a standalone test or a screening test for asthma. Bronchial challenge testing with ARIDOL should be used only as part of a physician's overall assessment of asthma.

Which are Aridol Bronchial Challenge Test Kit UNII Codes?

The UNII codes for the active ingredients in this product are:

* Please review the disclaimer below.

Product Footnotes

[1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

[3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".