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  5. NDC Package Code: 84639-212-04 Bronchitol

NDC Package 84639-212-04 Bronchitol

Mannitol Capsule Respiratory (inhalation) - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
84639-212-04
Package Description:
1 BLISTER PACK in 1 CARTON / 10 CAPSULE in 1 BLISTER PACK (84639-212-01)
Product Code:
84639-212
Proprietary Name:
Bronchitol
Non-Proprietary Name:
Mannitol
Substance Name:
Mannitol
Usage Information:
BRONCHITOL is indicated as add-on maintenance therapy to improve pulmonary function in adult patients 18 years and older with Cystic Fibrosis. Use BRONCHITOL only for adults who have passed the BRONCHITOL Tolerance Test [see Dosage and Administration (2.1)].
11-Digit NDC Billing Format:
84639021204
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
NDC to RxNorm Crosswalk:
Product Type:
Human Prescription Drug
Labeler Name:
Arna Pharma Pty Ltd
Dosage Form:
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route(s):
Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.
Active Ingredient(s):
MANNITOL 40 mg/101
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
NDA202049
Marketing Category:
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date:
10-02-2024
Listing Expiration Date:
12-31-2025
Exclude Flag:
N
Code Structure:

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the disclaimer below.

Other Product Packages

The following packages are also available for this product:

NDC Package CodePackage Description
84639-212-1414 BLISTER PACK in 1 CARTON / 10 CAPSULE in 1 BLISTER PACK (84639-212-01)
84639-212-564 CARTON in 1 BOX / 14 BLISTER PACK in 1 CARTON (84639-212-14) / 10 CAPSULE in 1 BLISTER PACK (84639-212-01)

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 84639-212-04?

The NDC Packaged Code 84639-212-04 is assigned to a package of 1 blister pack in 1 carton / 10 capsule in 1 blister pack (84639-212-01) of Bronchitol, a human prescription drug labeled by Arna Pharma Pty Ltd. The product's dosage form is capsule and is administered via respiratory (inhalation) form.This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package.

Is NDC 84639-212 included in the NDC Directory?

Yes, Bronchitol with product code 84639-212 is active and included in the NDC Directory. The product was first marketed by Arna Pharma Pty Ltd on October 02, 2024 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 84639-212-04?

The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 1.

What is the 11-digit format for NDC 84639-212-04?

The 11-digit format is 84639021204. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-3-284639-212-045-4-284639-0212-04