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  4. NDC Product Code: 70644-215 Formoterol Fumarate Inhalation Solution And Pari Lc Plus Nebulizer

NDC 70644-215 Formoterol Fumarate Inhalation Solution And Pari Lc Plus Nebulizer

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

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 70644-215?
  4. Formoterol Fumarate Inhalation Solution And Pari Lc Plus Nebulizer Uses
  5. Active Ingredients UNII Codes
  6. NDC to RxNorm Crosswalk
  7. Patient Education

Product Information

Get all the details for National Drug Code (NDC) 70644-215 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
70644-215
Proprietary Name:
Formoterol Fumarate Inhalation Solution And Pari Lc Plus Nebulizer
Non-Proprietary Name: [1]
Formoterol Fumarate Inhalation Solution And Pari Lc Plus Nebulizer
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]
Genericus, Inc.
Labeler Code:
70644
Product Label ID:
3da9b6eb-67fa-4baf-9d6b-1ad327e63c55
HCPCS Code:
J7606 - FORMOTEROL FUMARATE, INHALATION SOLUTION, FDA APPROVED FINAL PRODUCT, NON-COMPOUNDED, ADMINISTERED THROUGH DME, UNIT DOSE FORM, 20 MICROGRAMS
FDA Application Number: [6]
ANDA215883
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date: [9]
09-16-2024
Listing Expiration Date: [11]
12-31-2025
Exclude Flag: [12]
N
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Product Details

What is NDC 70644-215?

The NDC code 70644-215 is assigned by the FDA to the product Formoterol Fumarate Inhalation Solution And Pari Lc Plus Nebulizer which is a human prescription drug product labeled by Genericus, Inc.. The product's dosage form is kit. The product is distributed in 2 packages with assigned NDC codes 70644-215-30 1 kit in 1 package * 60 vial in 1 carton / 2 ml in 1 vial * 30 vial in 1 carton / 2 ml in 1 vial * 1 in 1 package, 70644-215-60 1 kit in 1 package * 60 vial in 1 carton / 2 ml in 1 vial * 30 vial in 1 carton / 2 ml in 1 vial * 1 in 1 package. 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 Formoterol Fumarate Inhalation Solution And Pari Lc Plus Nebulizer?

Use of a LABA, including formoterol fumarate inhalation solution, without an inhaled corticosteroid is contraindicated in patients with asthma [see WARNINGS and PRECAUTIONS (5.1)]. Formoterol fumarate inhalation solution is not indicated for the treatment of asthma.

Which are Formoterol Fumarate Inhalation Solution And Pari Lc Plus Nebulizer UNII Codes?

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

What is the NDC to RxNorm Crosswalk for Formoterol Fumarate Inhalation Solution And Pari Lc Plus Nebulizer?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 1246319 - formoterol fumarate 20 MCG in 2 ML Inhalation Solution
  • RxCUI: 1246319 - formoterol fumarate 0.01 MG/ML Inhalation Solution
  • RxCUI: 1246319 - formoterol fumarate 20 MCG per 2 ML Inhalation Solution
  • RxCUI: 1246319 - formoterol fumarate 20 MCG/2 ML Inhalation Solution

* Please review the disclaimer below.

Patient Education

Formoterol Oral Inhalation


Formoterol oral inhalation is used to control wheezing, shortness of breath, and chest tightness caused by chronic obstructive pulmonary disease (COPD; a group of lung diseases that includes chronic bronchitis and emphysema). Formoterol is in a class of medications called long-acting beta agonists (LABAs). It works by relaxing and opening air passages in the lungs, making it easier to breathe.
[Learn More]


* 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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".