Symbicort and Generic Budesonide/Formoterol Inhalers

Symbicort is a branded inhalation aerosol containing two active ingredients: budesonide and formoterol fumarate dihydrate. FDA-approved generic budesonide/formoterol inhalation aerosol products are also available in the United States.

Current U.S. labeling identifies Symbicort and generic budesonide/formoterol inhalation aerosol products as prescription drugs.

What are the active ingredients?

Budesonide is an inhaled corticosteroid. Formoterol is a long-acting beta2-adrenergic agonist (LABA). In the combination product, the two ingredients are delivered together through a metered-dose inhaler.

Current U.S. labeling for Symbicort-related inhalation aerosol uses two strengths expressed as the amount delivered per actuation:

• budesonide 80 mcg / formoterol 4.5 mcg;
• budesonide 160 mcg / formoterol 4.5 mcg.

The product-specific label determines the approved uses, age ranges, strength selection, and instructions. This page does not provide individualized asthma or COPD treatment recommendations.

Brand and generic product landscape

Symbicort is the branded reference product. In March 2022, FDA listed Breyna, from Mylan Pharmaceuticals Inc., a Viatris company, as the first approved generic of Symbicort in 80/4.5 mcg and 160/4.5 mcg strengths.

The generic landscape has continued to develop. Current DailyMed labeling also includes an ANDA budesonide/formoterol fumarate dihydrate inhalation aerosol from Teva Pharmaceuticals with 80/4.5 mcg and 160/4.5 mcg strengths and 120 actuations per canister.

A patient comparing brand and generic products should focus on the exact product dispensed rather than on the word "generic" alone. Important details include the NDC, manufacturer or labeler, strength, actuator, dose counter, package configuration, and product-specific instructions.

Is this the same as an albuterol rescue inhaler?

No. Budesonide/formoterol and albuterol are not the same medication.

Albuterol inhalation aerosol contains a short-acting beta2-adrenergic agonist. Symbicort-related products contain both an inhaled corticosteroid and a long-acting beta2-adrenergic agonist. Their FDA labeling, intended roles, and instructions differ.

The current budesonide/formoterol labeling specifically describes the product as a combination corticosteroid/LABA therapy. It should not be reduced to "another albuterol inhaler" or substituted on that assumption.

For comparison of the product category, see Albuterol Inhalers: Ventolin HFA and Generic Products.

Prescription status and substitution questions

Symbicort and the generic budesonide/formoterol inhalation aerosol products discussed here are prescription products. A prescription may identify a brand, an active-ingredient combination, a strength, or other dispensing details that affect what can be supplied.

Useful questions for a pharmacist include:

• Is the product Symbicort, Breyna, or another FDA-approved budesonide/formoterol inhalation aerosol?
• Which strength is prescribed: 80/4.5 or 160/4.5?
• Does the dispensed inhaler have the same active ingredients and strength as the prescription?
• Is the insurer requiring a particular brand or generic?
• Does a change in product require new device instructions?
• How many actuations are in the canister, and how does its counter work?
• Are there product-specific priming, cleaning, storage, or mouth-rinsing instructions?

The exact package insert should be followed because device and handling details belong to the specific product, not merely to the ingredient names.

Access, insurance, and formulary considerations

Coverage can vary by insurer and plan. A product may be FDA-approved yet still require a formulary alternative, prior authorization, or a different copay tier. Those are plan-specific access issues rather than differences in FDA approval status.

When coverage changes, patients should avoid assuming that any inhaler with similar-looking packaging is an equivalent replacement. The prescription, active ingredients, strength, device, and approved product identity should be checked.

Contact the pharmacy to confirm current availability and prescription requirements for a specific product.

For the broader respiratory research index, return to Respiratory Medications.

Why the two-number strength matters

Budesonide/formoterol strength is expressed with two numbers because the inhaler contains two active ingredients. A label showing 80/4.5 is not the same strength as one showing 160/4.5 even though the formoterol component is 4.5 mcg in both. The budesonide component differs.

That is why a product comparison should retain the full strength expression rather than shortening it to “4.5 mcg” or referring only to the brand. A pharmacy substitution review should match the prescribed combination and strength, not just the fact that the inhaler contains budesonide and formoterol.

FDA-approved generic does not mean every device detail is identical

FDA approval of a generic establishes the applicable regulatory relationship to the reference product, but patients should still use the instructions supplied with the exact inhaler they receive. Current generic labels describe metered-dose inhalers with their own actuator, counter, package configuration, and handling instructions.

If a refill changes from Symbicort to Breyna or another approved budesonide/formoterol inhalation aerosol, practical verification can include the product name, manufacturer or labeler, NDC, strength, actuation count, and device instructions. The pharmacist can also confirm whether the change is being made as a generic substitution or because the prescriber selected a different product.