Medicine
Albuterol 4 mg tablet
Albuterol 4 mg tablet is a generic prescription medicine for oral use, made by 9 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 at 20° to 25°C (68° to 77°F). Protect from light.
Key facts
- Active ingredient (INN)
- Albuterol
- Brand
- Sold under the generic name
- Strength
- 4 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 50 tablets and 23 more
- Manufacturers
- Sun Pharmaceutical IndustriesIndiaZydus LifesciencesIndiaAurobindo PharmaIndiaProficient RxBryant Ranch PrepackAmneal Pharmaceuticals NYRising Pharma HoldingsChartwell RXGolden State Medical Supply
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F). Protect from light.
- 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
- 5 December 1989
- Identifiers
- RxCUI 197316, 197318DailyMed set ID c3fa0068-fd12-45de-818e-e929fb45ba05, a22af54a-c010-ab8b-e053-2a95a90a8862, 601a18ed-d66e-498f-a804-f1a3330827d4 +7NDC 70710-1062, 51407-368, 63629-2611 +7Application ANDA208884, ANDA072637, ANDA207046 +3
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 |
|---|---|---|---|
| 100 tablet in 1 bottle | 70710-1062-1 | Zydus LifesciencesIndia | 23 October 2020 |
| 500 tablet in 1 bottle | 70710-1062-5 | Zydus LifesciencesIndia | 23 October 2020 |
| 100 tablet in 1 bottle | 70771-1512-1 | Zydus LifesciencesIndia | 23 October 2020 |
| 500 tablet in 1 bottle | 70771-1512-5 | Zydus LifesciencesIndia | 23 October 2020 |
| 100 tablet in 1 bottle | 59651-334-01 | Aurobindo PharmaIndia | 14 May 2020 |
| 500 tablet in 1 bottle | 59651-334-05 | Aurobindo PharmaIndia | 14 May 2020 |
| 100 tablet in 1 bottle | 53489-177-01 | Sun Pharmaceutical IndustriesIndia | 5 December 1989 |
| 50 tablet in 1 bottle | 53489-177-02 | Sun Pharmaceutical IndustriesIndia | 5 December 1989 |
| 250 tablet in 1 bottle | 53489-177-03 | Sun Pharmaceutical IndustriesIndia | 5 December 1989 |
| 500 tablet in 1 bottle | 53489-177-05 | Sun Pharmaceutical IndustriesIndia | 5 December 1989 |
| 1000 tablet in 1 bottle | 53489-177-10 | Sun Pharmaceutical IndustriesIndia | 5 December 1989 |
| 100 tablet in 1 bottle | 69238-1345-1 | Amneal Pharmaceuticals NY | 24 May 2018 |
| 500 tablet in 1 bottle | 69238-1345-5 | Amneal Pharmaceuticals NY | 24 May 2018 |
| 90 tablet in 1 bottle | 62135-672-90 | Chartwell RX | 14 June 2023 |
| 100 tablet in 1 bottle | 64980-443-01 | Rising Pharma Holdings | 29 June 2018 |
| 500 tablet in 1 bottle | 64980-443-50 | Rising Pharma Holdings | 29 June 2018 |
| 20 tablet in 1 bottle | 63629-2611-1 | Bryant Ranch Prepack | 8 April 2025 |
| 30 tablet in 1 bottle | 63629-2611-2 | Bryant Ranch Prepack | 8 April 2025 |
| 60 tablet in 1 bottle | 63629-2611-3 | Bryant Ranch Prepack | 8 April 2025 |
| 100 tablet in 1 bottle | 51407-368-01 | Golden State Medical Supply | 26 March 2020 |
| 100 tablet in 1 bottle | 71205-899-00 | Proficient Rx | 30 July 2021 |
| 1000 tablet in 1 bottle | 71205-899-11 | Proficient Rx | 30 July 2021 |
| 30 tablet in 1 bottle | 71205-899-30 | Proficient Rx | 30 July 2021 |
| 500 tablet in 1 bottle | 71205-899-55 | Proficient Rx | 30 July 2021 |
| 60 tablet in 1 bottle | 71205-899-60 | Proficient Rx | 30 July 2021 |
| 90 tablet in 1 bottle | 71205-899-90 | Proficient Rx | 30 July 2021 |
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 4 mg tablet 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.