Medicine
Albuterol 2.5 mg/3 mL inhalation solution
Albuterol 2.5 mg/3 mL inhalation solution is a generic prescription medicine for inhalation use, made by 15 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.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store between 2° and 25° C (68°F and 77°F). excrusions permitted to 15°C to…
Key facts
- Active ingredient (INN)
- Albuterol
- Brand
- Sold under the generic name
- Strength
- 2.5 mg/3 mL
- Dosage form
- Inhalation solution
- Route
- Inhalation
- Packs
- 6 pouches, 1 pouch, 30 pouches and 37 more
- Manufacturers
- AsclemedA-S Medication SolutionsMylan PharmaceuticalsNephron PharmaceuticalsRitedose PharmaceuticalsSportpharmNuCare Pharmaceuticals,IncRising Pharma HoldingsCardinal HealthAmerican Health Packaging
- Origin register
- US FDA, United States
- Storage
- Store between 2° and 25° C (68°F and 77°F). excrusions permitted to 15°C to 30°C (59°F and 86°F). Store vials in pouch until time of use.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- R03AC02 Albuterol
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 17 September 1997
- Identifiers
- RxCUI 630208DailyMed set ID 8f52f15f-3fb7-4b00-a19f-8721c5ac55db, 32377c09-da6d-331c-e063-6294a90a7a46, 574824f3-51cc-4b94-9c10-e3204d8b19f8 +18NDC 50090-6560, 64980-641, 0487-9501 +17Application ANDA074880, ANDA077839
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 |
|---|---|---|---|
| 6 pouch in 1 carton / 5 vial in 1 pouch / 3 mL in 1 vial | 62135-828-84 | Chartwell RX | 18 January 2024 |
| 1 pouch in 1 carton / 25 ampule in 1 pouch / 3 mL in 1 ampule | 0378-8270-52 | Mylan Pharmaceuticals | 18 December 2012 |
| 30 pouch in 1 carton / 1 ampule in 1 pouch / 3 mL in 1 ampule | 0378-8270-55 | Mylan Pharmaceuticals | 6 March 2014 |
| 2 pouch in 1 carton / 30 ampule in 1 pouch / 3 mL in 1 ampule | 0378-8270-91 | Mylan Pharmaceuticals | 11 April 2013 |
| 1 pouch in 1 carton / 30 ampule in 1 pouch / 3 mL in 1 ampule | 0378-8270-93 | Mylan Pharmaceuticals | 22 January 2013 |
| 30 pouch in 1 carton / 1 vial, single-dose in 1 pouch / 3 mL in 1 vial, single-dose | 0487-9501-01 | Nephron Pharmaceuticals | 17 September 1997 |
| 1 pouch in 1 carton / 30 vial, single-dose in 1 pouch / 3 mL in 1 vial, single-dose | 0487-9501-03 | Nephron Pharmaceuticals | 17 September 1997 |
| 1 pouch in 1 carton / 25 vial, single-dose in 1 pouch / 3 mL in 1 vial, single-dose | 0487-9501-25 | Nephron Pharmaceuticals | 17 September 1997 |
| 2 pouch in 1 carton / 30 vial, single-dose in 1 pouch / 3 mL in 1 vial, single-dose | 0487-9501-60 | Nephron Pharmaceuticals | 17 September 1997 |
| 1 pouch in 1 carton / 25 vial, single-dose in 1 pouch / 3 mL in 1 vial, single-dose | 64980-641-02 | Rising Pharma Holdings | 14 March 2025 |
| 1 pouch in 1 carton / 30 vial, single-dose in 1 pouch / 3 mL in 1 vial, single-dose | 64980-641-03 | Rising Pharma Holdings | 14 March 2025 |
| 2 pouch in 1 carton / 30 vial, single-dose in 1 pouch / 3 mL in 1 vial, single-dose | 64980-641-06 | Rising Pharma Holdings | 14 March 2025 |
| 30 pouch in 1 carton / 1 ampule in 1 pouch / 3 mL in 1 ampule | 76204-200-01 | Ritedose Pharmaceuticals | 5 December 2011 |
| 1 pouch in 1 carton / 25 ampule in 1 pouch / 3 mL in 1 ampule | 76204-200-25 | Ritedose Pharmaceuticals | 5 December 2011 |
| 1 pouch in 1 carton / 30 ampule in 1 pouch / 3 mL in 1 ampule | 76204-200-30 | Ritedose Pharmaceuticals | 5 December 2011 |
| 2 pouch in 1 carton / 30 ampule in 1 pouch / 3 mL in 1 ampule | 76204-200-60 | Ritedose Pharmaceuticals | 5 December 2011 |
| 1 vial, single-dose in 1 carton / 3 mL in 1 vial, single-dose | 76420-087-03 | Asclemed | 16 October 2020 |
| 1 pouch in 1 carton / 25 vial, single-dose in 1 pouch / 3 mL in 1 vial, single-dose | 76420-087-25 | Asclemed | 6 November 2025 |
| 30 pouch in 1 carton / 1 vial, single-dose in 1 pouch / 3 mL in 1 vial, single-dose | 87063-031-01 | Asclemed | 7 November 2025 |
| 1 pouch in 1 carton / 25 vial, single-dose in 1 pouch / 3 mL in 1 vial, single-dose | 87063-031-25 | Asclemed | 7 November 2025 |
| 1 pouch in 1 carton / 30 vial, single-dose in 1 pouch / 3 mL in 1 vial, single-dose | 87063-031-30 | Asclemed | 7 November 2025 |
| 2 pouch in 1 carton / 30 vial, single-dose in 1 pouch / 3 mL in 1 vial, single-dose | 87063-031-60 | Asclemed | 7 November 2025 |
| 1 pouch in 1 carton / 25 ampule in 1 pouch / 3 mL in 1 ampule | 68071-3780-2 | NuCare Pharmaceuticals | 21 January 2025 |
| 3 mL in 1 container | 68071-4543-6 | NuCare Pharmaceuticals,Inc | 29 August 2018 |
| 3 mL in 1 vial, single-dose | 68071-4754-2 | NuCare Pharmaceuticals,Inc | 6 February 2019 |
| 1 pouch in 1 carton / 25 mL in 1 pouch | 50090-0516-0 | A-S Medication Solutions | 29 June 2016 |
| 5 pouch in 1 carton / 25 mL in 1 pouch | 50090-0516-1 | A-S Medication Solutions | 29 June 2016 |
| 25 pouch in 1 carton / 3 mL in 1 pouch | 50090-6560-0 | A-S Medication Solutions | 17 July 2023 |
| 75 pouch in 1 carton / 3 mL in 1 pouch | 50090-6560-1 | A-S Medication Solutions | 24 July 2023 |
| 5 pouch in 1 bag / 1 ampule in 1 pouch / 3 mL in 1 ampule | 55154-2132-5 | Cardinal Health | 16 January 2023 |
| 5 pouch in 1 bag / 1 ampule in 1 pouch / 3 mL in 1 ampule | 55154-4410-5 | Cardinal Health | 16 February 2023 |
| 30 pouch in 1 carton / 1 ampule in 1 pouch / 3 mL in 1 ampule | 60687-395-83 | American Health Packaging | 11 January 2019 |
| 5 vial, single-dose in 1 pouch / 3 mL in 1 vial, single-dose | 51662-1499-1 | HealthFirst | 29 January 2020 |
| 1 ampule in 1 bag / 3 mL in 1 ampule | 71872-7054-1 | Medical Purchasing Solutions | 6 March 2018 |
| 25 ampule in 1 pouch / 3 mL in 1 ampule | 68788-8399-2 | Preferred Pharmaceuticals | 1 March 2023 |
| 1 pouch in 1 carton / 25 vial, single-dose in 1 pouch / 3 mL in 1 vial, single-dose | 63187-204-25 | Proficient Rx | 1 November 2018 |
| 30 pouch in 1 carton / 1 vial, single-dose in 1 pouch / 3 mL in 1 vial, single-dose | 85766-127-01 | Sportpharm | 7 November 2025 |
| 1 pouch in 1 carton / 25 vial, single-dose in 1 pouch / 3 mL in 1 vial, single-dose | 85766-127-25 | Sportpharm | 7 November 2025 |
| 1 pouch in 1 carton / 30 vial, single-dose in 1 pouch / 3 mL in 1 vial, single-dose | 85766-127-30 | Sportpharm | 7 November 2025 |
| 2 pouch in 1 carton / 30 vial, single-dose in 1 pouch / 3 mL in 1 vial, single-dose | 85766-127-60 | Sportpharm | 7 November 2025 |
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 1 May 1981 | 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
Other strengths and forms of Albuterol
Clinical summary
Albuterol is a beta2-adrenergic agonist indicated in adults and children 4 years of age and older for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm. MedsAcross supplies Albuterol 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 AlbuterolFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Albuterol Sulfate prescribing information (Sandoz) · U.S. National Library of Medicine, DailyMed
Need Albuterol 2.5 mg/3 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.