Formoterol Fumarate Solution
NDC Package 70748-261-60

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Other Packages
    4. Frequently Asked Questions

Package Information

Formoterol Fumarate solution is formoterol is used as a long-term (maintenance) treatment to prevent or decrease breathing problems caused by ongoing lung diseases (chronic obstructive pulmonary disease-COPD, including chronic bronchitis and emphysema). This formulation utilizes a solution delivery system. Marketed by Lupin Pharmaceuticals, Inc., this product is identified by NDC 70748-261 and is authorized under FDA application ANDA215053.

Identification & Billing

NDC Package Code
70748-261-60
Package Description
60 POUCH in 1 CARTON / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL
Product Code
70748-261
11-Digit Billing Format
70748026160
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Formoterol Fumarate
Non-Proprietary Name
Formoterol Fumarate
Substance Name
Formoterol Fumarate
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.
Active Ingredient(s)
FORMOTEROL FUMARATE 20 ug/2mL
Pharmacologic Class
Usage Information
Formoterol is used as a long-term (maintenance) treatment to prevent or decrease breathing problems caused by ongoing lung diseases (chronic obstructive pulmonary disease-COPD, including chronic bronchitis and emphysema). Formoterol belongs to the class of drugs known as long-acting inhaled beta-agonists (LABAs). It works by relaxing the muscles around the airways so that they open up and you can breathe more easily. This effect helps to reduce wheezing, coughing, and shortness of breath. This medication does not work right away and should not be used for sudden attacks of breathing trouble. Your doctor must prescribe a quick-relief inhaler (e.g., albuterol, also called salbutamol in some countries) for sudden shortness of breath while you are using formoterol. You should always have a quick-relief inhaler with you. This form of formoterol is not approved to treat asthma. People with asthma using long-acting inhaled beta agonists (such as formoterol) without also using an inhaled corticosteroid may have an increased risk of serious (sometimes fatal) breathing problems.

Regulatory & Marketing

Labeler Name
Lupin Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA215053
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-28-2022
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J7606
Source: ASP
Formoterol fumarate, inh
HCPCS Dosage 20 MCG
Units / Pkg 60

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (70748-261). Click a package code to view its specific billing and regulatory data.

70748-261-30
30 POUCH in 1 CARTON / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 70748-261-60 identifies a specific commercial package of 60 pouch in 1 carton / 1 vial in 1 pouch / 2 ml in 1 vial of Formoterol Fumarate, a human prescription drug labeled by Lupin Pharmaceuticals, Inc.. This solution is formulated for respiratory (inhalation) use and contains formoterol fumarate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Lupin Pharmaceuticals, Inc. on November 28, 2022. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Formoterol is used as a long-term (maintenance) treatment to prevent or decrease breathing problems caused by ongoing lung diseases (chronic obstructive pulmonary disease-COPD, including chronic bronchitis and emphysema). Formoterol belongs to the class of drugs known as long-acting inhaled beta-agonists (LABAs). It works by relaxing the muscles around the airways so that they open up and you can breathe more easily. This effect helps to reduce wheezing, coughing, and shortness of breath. This medication does not work right away and should not be used for sudden attacks of breathing trouble. Your doctor must prescribe a quick-relief inhaler (e.g., albuterol, also called salbutamol in some countries) for sudden shortness of breath while you are using formoterol. You should always have a quick-relief inhaler with you. This form of formoterol is not approved to treat asthma. People with asthma using long-acting inhaled beta agonists (such as formoterol) without also using an inhaled corticosteroid may have an increased risk of serious (sometimes fatal) breathing problems.

How is this Lupin Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70748026160. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
70748-261-60
11-Digit CMS (5-4-2)
70748-0261-60

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.