Quick answers
- What is Arformoterol tartrate used for?
- The FDA-approved label (Arformoterol Tartrate, American Health Packaging, August 20, 2026) says: “Arformoterol tartrate inhalation solution is a long-acting beta 2 -adrenergic agonist (beta 2 -agonist) indicated for: Long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. Important limitations of use …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Arformoterol tartrate have a boxed warning?
- No. None of the 15 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Arformoterol tartrate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Arformoterol tartrate been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started September 29, 2022 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Arformoterol tartrate?
- 15 companies list prescription products of Arformoterol tartrate in the FDA NDC Directory, including Fosun Pharma USA Inc., Lifestar Pharma LLC and Micro Labs Limited.
What Arformoterol tartrate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Arformoterol tartrate inhalation solution is a long-acting beta 2 -adrenergic agonist (beta 2 -agonist) indicated for: Long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. Important limitations of use …
— FDA label: Arformoterol Tartrate, American Health Packaging, effective August 20, 2026. Read the full label on DailyMed →
The FDA has 15 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 15 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Solution |
|---|---|
| Route | Respiratory (inhalation) |
| Prescription products | 15 in the FDA NDC Directory |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| arformoterol tartrate 15 ug/2 mL solution | Generic | $0.6065–$0.6404 per mL 27 packages, lowest to highest |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Fosun Pharma USA Inc.1 product
- Lifestar Pharma LLC1 product
- Micro Labs Limited1 product
- American Health Packaging1 product
- Slate Run Pharmaceuticals1 product
- Ritedose Pharmaceuticals, LLC1 product
- Lupin Pharmaceuticals, Inc.1 product
- Dr. Reddy's Laboratories Inc.1 product
- Cipla USA Inc.1 product
- Alembic Pharmaceuticals Inc.1 product
- NorthStar RxLLC1 product
- Aucta Pharmaceuticals, Inc.1 product
- Ingenus Pharmaceuticals, LLC1 product
- Sun Pharmaceutical Industries, Inc.1 product
- Devatis, Inc.1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (13)
- ANDA207306Cipla · June 22, 2021
- ANDA213762Adaptis · June 22, 2021
- ANDA213068Lupin · February 7, 2022
- ANDA214736Ritedose Corp · March 2, 2022
- ANDA214779Alembic · May 10, 2022
- ANDA215385Sun Pharm · May 26, 2022
- ANDA216128Mankind Pharma · November 15, 2022
- ANDA214901Aiping Pharm Inc · April 2, 2024
- ANDA215032DR Reddys · June 3, 2024
- ANDA218156Lexenpharm · November 18, 2024
- ANDA218380Pharmazone · February 3, 2025
- ANDA218555Micro Labs · March 7, 2025
- ANDA218429Saba Ilac Sanayi · April 25, 2025
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
September 29, 2022 · Class II · Terminated · D-1550-2022
Lack of Assurance of Sterility: environmental monitoring failure.
Arformoterol Tartrate Inhalation Solution, 15 mcg/2mL, 2 mL Sterile Unit-Dose Vial packaged in 5 x 2 mL Sterile Unit-Dose Vials per pouch, NDC 69097-168-48; 60 (12 x 5) x 2 mL Sterile Unit-Dose Vials per carton, NDC 6909 — CIPLA
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 668956 |
|---|---|
| SPL set ID of the quoted label | bb1a6643-f280-4f02-a824-0428a2b82d3c |
| FDA labels (SPL) | 15 |
| FDA applications | 13 ANDA |
| Active ingredients (FDA) | ARFORMOTEROL |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Arformoterol Tartrate, American Health Packaging, effective August 20, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →