Medicine
Formoterol 20 mcg/2 mL inhalation solution
Formoterol 20 mcg/2 mL inhalation solution is a generic prescription medicine for inhalation use, made by 12 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians. It ships in a temperature-controlled cold chain.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Cold chain
Store in a refrigerator, 2°C to 8°C (36°F to 46°F). After dispensing to the…
Key facts
- Active ingredient (INN)
- Formoterol
- Brand
- Sold under the generic name
- Strength
- 20 mcg/2 mL
- Dosage form
- Inhalation solution
- Route
- Inhalation
- Packs
- 30 pouches, 60 pouches and 21 more
- Manufacturers
- Alembic PharmaceuticalsIndiaDr. Reddy's LaboratoriesIndiaLifestar PharmaIndiaLupinIndiaMicro LabsIndiaBryant Ranch PrepackDevatisIngenus PharmaceuticalsMylan PharmaceuticalsNorthStar RxLLC
- Origin register
- US FDA, United States
- Storage
- Store in a refrigerator, 2°C to 8°C (36°F to 46°F). After dispensing to the patient: Store in a refrigerator at 2°C to 8°C (36°F to 46°F) and discard when drug expires or store at room temperature, 20°C to 25°C (68°F to 77°F) and discard if not used after 3 months. Vial should always be stored in the foil pouch, and only removed IMMEDIATELY before use.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- R03AC13 Formoterol
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 22 June 2021
- Identifiers
- RxCUI 1246319DailyMed set ID 0796acea-70d6-479f-af48-18723b1efd2a, 419bc85d-8e24-478b-921e-babfb73e79f3, 2d9bf685-8886-4865-834b-2748af124b79 +10NDC 42571-463, 0093-4061, 76204-030 +10Application ANDA218304, ANDA091141, ANDA216486 +7
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 30 pouch in 1 carton / 1 vial in 1 pouch / 2 mL in 1 vial | 62332-655-30 | Alembic PharmaceuticalsIndia | 22 November 2021 |
| 60 pouch in 1 carton / 1 vial in 1 pouch / 2 mL in 1 vial | 62332-655-60 | Alembic PharmaceuticalsIndia | 22 November 2021 |
| 30 pouch in 1 carton / 1 vial in 1 pouch / 2 mL in 1 vial | 43598-778-30 | Dr. Reddy's LaboratoriesIndia | 30 January 2025 |
| 60 pouch in 1 carton / 1 vial in 1 pouch / 2 mL in 1 vial | 43598-778-60 | Dr. Reddy's LaboratoriesIndia | 30 January 2025 |
| 60 pouch in 1 carton / 4 vial in 1 pouch / 2 mL in 1 vial | 70756-608-60 | Lifestar PharmaIndia | 22 March 2023 |
| 30 pouch in 1 carton / 1 vial in 1 pouch / 2 mL in 1 vial | 70756-608-70 | Lifestar PharmaIndia | 22 March 2023 |
| 30 pouch in 1 carton / 1 vial in 1 pouch / 2 mL in 1 vial | 70748-261-30 | LupinIndia | 28 November 2022 |
| 60 pouch in 1 carton / 1 vial in 1 pouch / 2 mL in 1 vial | 70748-261-60 | LupinIndia | 28 November 2022 |
| 60 pouch in 1 carton / 1 vial in 1 pouch / 2 mL in 1 vial | 42571-463-62 | Micro LabsIndia | 1 October 2024 |
| 30 pouch in 1 carton / 1 vial in 1 pouch / 2 mL in 1 vial | 42571-463-73 | Micro LabsIndia | 1 October 2024 |
| 30 pouch in 1 carton / 1 vial in 1 pouch / 2 mL in 1 vial | 73043-051-93 | Devatis | 30 June 2025 |
| 60 pouch in 1 carton / 1 vial in 1 pouch / 2 mL in 1 vial | 73043-051-96 | Devatis | 30 June 2025 |
| 30 pouch in 1 carton / 1 vial, single-dose in 1 pouch / 2 mL in 1 vial, single-dose | 50742-394-30 | Ingenus Pharmaceuticals | 6 June 2025 |
| 60 pouch in 1 carton / 1 vial, single-dose in 1 pouch / 2 mL in 1 vial, single-dose | 50742-394-60 | Ingenus Pharmaceuticals | 5 June 2025 |
| 60 pouch in 1 carton / 1 vial in 1 pouch / 2 mL in 1 vial | 0378-1631-91 | Mylan Pharmaceuticals | 22 June 2021 |
| 30 pouch in 1 carton / 1 vial in 1 pouch / 2 mL in 1 vial | 0378-1631-93 | Mylan Pharmaceuticals | 22 June 2021 |
| 30 pouch in 1 carton / 1 vial in 1 pouch / 2 mL in 1 vial | 76204-030-01 | Ritedose Pharmaceuticals | 14 March 2025 |
| 60 pouch in 1 carton / 1 vial in 1 pouch / 2 mL in 1 vial | 76204-030-02 | Ritedose Pharmaceuticals | 14 March 2025 |
| 60 pouch in 1 carton / 1 vial in 1 pouch / 2 mL in 1 vial | 0093-4061-06 | Teva Pharmaceuticals | 22 June 2021 |
| 30 pouch in 1 carton / 1 vial in 1 pouch / 2 mL in 1 vial | 0093-4061-30 | Teva Pharmaceuticals | 22 June 2021 |
| 30 pouch in 1 carton / 1 vial in 1 pouch / 2 mL in 1 vial | 63629-8813-1 | Bryant Ranch Prepack | 10 September 2021 |
| 60 pouch in 1 carton / 1 vial in 1 pouch / 2 mL in 1 vial | 63629-8814-1 | Bryant Ranch Prepack | 10 September 2021 |
| 30 pouch in 1 carton / 1 vial in 1 pouch / 2 mL in 1 vial | 72603-620-30 | NorthStar RxLLC | 1 July 2024 |
| 60 pouch in 1 carton / 4 vial in 1 pouch / 2 mL in 1 vial | 72603-620-60 | NorthStar RxLLC | 1 July 2024 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 16 February 2001 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Alternatives
Other makers and brands of Formoterol 20 mcg/2 mL inhalation solution.
Clinical summary
Formoterol is a beta2-adrenergic 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, among other approved uses. MedsAcross supplies Formoterol for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about FormoterolFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- FORMOTEROL FUMARATE prescribing information (Mylan Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Formoterol 20 mcg/2 mL inhalation solution for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.