Medicine
Albuterol 0.63 mg/3 mL inhalation solution
Albuterol 0.63 mg/3 mL inhalation solution is a generic prescription medicine for inhalation use, made by 8 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 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to…
Key facts
- Active ingredient (INN)
- Albuterol
- Brand
- Sold under the generic name
- Strength
- 0.63 mg/3 mL
- Dosage form
- Inhalation solution
- Route
- Inhalation
- Packs
- 5 pouches, 6 pouches, 30 pouches and 8 more
- Manufacturers
- Aurobindo PharmaIndiaLuoxin Aurovitas Pharma (Chengdu)Ritedose PharmaceuticalsChartwell RXIngenus PharmaceuticalsMylan PharmaceuticalsNephron PharmaceuticalsRising Pharma Holdings
- Origin register
- US FDA, United States
- Storage
- Store between 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Rx Only Manufactured By: Nephron Pharmaceuticals Corporation West Columbia, SC 29172 STORING YOUR MEDICINE Store albuterol inhalation solution between 20°C to 25°C (68°F to 77°F). Protect from light and excessive heat. Store unit-dose vials in protective foil pouch at all times.
- 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
- 31 March 2010
- Identifiers
- RxCUI 351136, 351137DailyMed set ID 285a656c-f77f-4e77-b0a8-a0e9c901803f, 1d6be2b8-c670-b783-e063-6294a90ae503, 32474c0e-af35-69d1-e063-6394a90a53c6 +5NDC 0487-0301, 81894-105, 64980-643 +5Application ANDA076355, ANDA211888, ANDA215571 +1
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 |
|---|---|---|---|
| 5 pouch in 1 carton / 5 vial in 1 pouch / 3 mL in 1 vial | 59651-183-25 | Aurobindo PharmaIndia | 20 April 2020 |
| 6 pouch in 1 carton / 5 vial in 1 pouch / 3 mL in 1 vial | 59651-183-30 | Aurobindo PharmaIndia | 29 July 2024 |
| 30 pouch in 1 carton / 1 vial in 1 pouch / 3 mL in 1 vial | 62135-826-84 | Chartwell RX | 19 January 2024 |
| 5 pouch in 1 carton / 5 vial in 1 pouch / 3 mL in 1 vial | 50742-392-25 | Ingenus Pharmaceuticals | 1 November 2024 |
| 5 pouch in 1 carton / 5 vial in 1 pouch / 3 mL in 1 vial | 81894-105-25 | Luoxin Aurovitas Pharma (Chengdu) | 20 April 2020 |
| 6 pouch in 1 carton / 5 vial in 1 pouch / 3 mL in 1 vial | 81894-105-30 | Luoxin Aurovitas Pharma (Chengdu) | 29 July 2024 |
| 5 pouch in 1 carton / 5 vial in 1 pouch / 3 mL in 1 vial | 0378-7057-52 | Mylan Pharmaceuticals | 7 October 2022 |
| 30 pouch in 1 carton / 1 vial, single-dose in 1 pouch / 3 mL in 1 vial, single-dose | 0487-0301-01 | Nephron Pharmaceuticals | 31 March 2010 |
| 30 pouch in 1 carton / 1 vial, single-dose in 1 pouch / 3 mL in 1 vial, single-dose | 64980-643-03 | Rising Pharma Holdings | 30 April 2025 |
| 30 pouch in 1 carton / 1 vial in 1 pouch / 3 mL in 1 vial | 76204-010-01 | Ritedose Pharmaceuticals | 4 January 2022 |
| 25 pouch in 1 carton / 5 vial in 1 pouch / 3 mL in 1 vial | 76204-010-55 | Ritedose Pharmaceuticals | 4 January 2022 |
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 0.63 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.