Medicine
Albuterol and Ipratropium 2.5 mg/0.5 mg per 3 mL inhalation solution
Albuterol and Ipratropium 2.5 mg/0.5 mg per 3 mL inhalation solution is a generic prescription medicine for inhalation use, made by 10 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°C and 25°C (36°F and 77°F). Store in pouch until time of use…
Key facts
- Active ingredient (INN)
- Albuterol and Ipratropium
- Brand
- Sold under the generic name
- Strength
- 2.5 mg/0.5 mg per 3 mL
- Dosage form
- Inhalation solution
- Route
- Inhalation
- Packs
- 6 pouches, 12 pouches, 30 pouches and 21 more
- Manufacturers
- CiplaIndiaAurobindo PharmaIndiaSun Pharmaceutical IndustriesIndiaRitedose PharmaceuticalsMylan PharmaceuticalsGolden State Medical SupplyA-S Medication SolutionsAmerican Health PackagingProficient RxRedpharm Drug
- Origin register
- US FDA, United States
- Storage
- Store between 2°C and 25°C (36°F and 77°F). Store in pouch until time of use. Protect from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 31 December 2007
- Identifiers
- RxCUI 1437702DailyMed set ID 89d59bd9-c826-413c-8ed9-a1521a0c7cc5, 23c05e9a-9df5-4978-8831-cf562aa4ba92, 38f9a201-3954-4370-8e71-7ec2df88a1ff +8NDC 69097-840, 0378-9671, 47335-756 +8Application ANDA202496, ANDA207875, ANDA206532 +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 |
|---|---|---|---|
| 6 pouch in 1 carton / 5 vial in 1 pouch / 3 mL in 1 vial | 69097-173-53 | CiplaIndia | 31 December 2007 |
| 12 pouch in 1 carton / 5 vial in 1 pouch / 3 mL in 1 vial | 69097-173-64 | CiplaIndia | 31 December 2007 |
| 30 pouch in 1 carton / 1 vial in 1 pouch / 3 mL in 1 vial | 69097-840-53 | CiplaIndia | 1 June 2020 |
| 2 pouch in 1 carton / 30 vial in 1 pouch / 3 mL in 1 vial | 69097-840-64 | CiplaIndia | 1 June 2020 |
| 1 pouch in 1 carton / 30 vial in 1 pouch / 3 mL in 1 vial | 69097-840-87 | CiplaIndia | 1 June 2020 |
| 30 pouch in 1 carton / 1 vial, single-dose in 1 pouch / 3 mL in 1 vial, single-dose | 65862-906-03 | Aurobindo PharmaIndia | 9 July 2020 |
| 6 pouch in 1 carton / 5 vial, single-dose in 1 pouch / 3 mL in 1 vial, single-dose | 65862-906-30 | Aurobindo PharmaIndia | 9 July 2020 |
| 12 pouch in 1 carton / 5 vial, single-dose in 1 pouch / 3 mL in 1 vial, single-dose | 65862-906-60 | Aurobindo PharmaIndia | 9 July 2020 |
| 6 pouch in 1 carton / 5 vial in 1 pouch / 3 mL in 1 vial | 47335-756-49 | Sun Pharmaceutical IndustriesIndia | 15 November 2021 |
| 12 pouch in 1 carton / 5 vial in 1 pouch / 3 mL in 1 vial | 47335-756-52 | Sun Pharmaceutical IndustriesIndia | 15 November 2021 |
| 1 pouch in 1 carton / 30 ampule in 1 pouch / 3 mL in 1 ampule | 0378-9671-30 | Mylan Pharmaceuticals | 1 March 2013 |
| 2 pouch in 1 carton / 30 ampule in 1 pouch / 3 mL in 1 ampule | 0378-9671-60 | Mylan Pharmaceuticals | 1 March 2013 |
| 30 pouch in 1 carton / 1 ampule in 1 pouch / 3 mL in 1 ampule | 0378-9671-93 | Mylan Pharmaceuticals | 1 March 2013 |
| 30 pouch in 1 carton / 1 ampule in 1 pouch / 3 mL in 1 ampule | 76204-600-01 | Ritedose Pharmaceuticals | 15 October 2012 |
| 6 pouch in 1 carton / 5 ampule in 1 pouch / 3 mL in 1 ampule | 76204-600-05 | Ritedose Pharmaceuticals | 15 October 2012 |
| 12 pouch in 1 carton / 5 ampule in 1 pouch / 3 mL in 1 ampule | 76204-600-12 | Ritedose Pharmaceuticals | 15 October 2012 |
| 1 pouch in 1 carton / 30 ampule in 1 pouch / 3 mL in 1 ampule | 76204-600-30 | Ritedose Pharmaceuticals | 15 October 2012 |
| 2 pouch in 1 carton / 30 ampule in 1 pouch / 3 mL in 1 ampule | 76204-600-60 | Ritedose Pharmaceuticals | 15 October 2012 |
| 30 vial in 1 carton / 3 mL in 1 vial | 50090-1382-0 | A-S Medication Solutions | 28 November 2014 |
| 30 pouch in 1 carton / 1 ampule in 1 pouch / 3 mL in 1 ampule | 60687-405-83 | American Health Packaging | 21 January 2019 |
| 1 pouch in 1 carton / 30 ampule in 1 pouch / 3 mL in 1 ampule | 60429-975-30 | Golden State Medical Supply | 17 October 2017 |
| 2 pouch in 1 carton / 30 ampule in 1 pouch / 3 mL in 1 ampule | 60429-975-60 | Golden State Medical Supply | 17 October 2017 |
| 1 pouch in 1 bag / 5 vial in 1 pouch / 3 mL in 1 vial | 71205-726-15 | Proficient Rx | 1 December 2022 |
| 1 pouch in 1 carton / 30 ampule in 1 pouch / 3 mL in 1 ampule | 67296-2315-9 | Redpharm Drug | 15 October 2012 |
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 24 October 1996 | 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 and Ipratropium
Clinical summary
Albuterol and Ipratropium is a fixed-dose combination of an anticholinergic and a beta2-adrenergic agonist indicated in patients with chronic obstructive pulmonary disease (COPD) on a regular aerosol bronchodilator, among other approved uses. MedsAcross supplies Albuterol and Ipratropium 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 Albuterol and IpratropiumFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Combivent Respimat prescribing information (Boehringer Ingelheim Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Albuterol and Ipratropium 2.5 mg/0.5 mg per 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.