Medicine
Ipratropium 0.5 mg/2.5 mL inhalation solution
Ipratropium 0.5 mg/2.5 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.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store between 59°F (15°C) and 86°F (30°C). Protect from light. Store unused…
Key facts
- Active ingredient (INN)
- Ipratropium
- Brand
- Sold under the generic name
- Strength
- 0.5 mg/2.5 mL
- Dosage form
- Inhalation solution
- Route
- Inhalation
- Packs
- 30 pouches, 1 pouch, 2 pouches and 28 more
- Manufacturers
- Aurobindo PharmaIndiaSun Pharmaceutical IndustriesIndiaNephron PharmaceuticalsMylan PharmaceuticalsRitedose PharmaceuticalsRising Pharma HoldingsA-S Medication SolutionsCardinal HealthAmerican Health PackagingChartwell RX
- Origin register
- US FDA, United States
- Storage
- Store between 59°F (15°C) and 86°F (30°C). Protect from light. Store unused vials in the foil pouch.
- 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
- 27 September 2001
- Identifiers
- RxCUI 836358DailyMed set ID 51350fab-a919-4d97-9d0c-d9dc7286244c, 22479633-624a-4251-ad3c-1dcba5d503fb, 52c63e41-dbbc-d9d7-e063-6294a90a30c9 +11NDC 55154-2134, 76204-100, 67296-2246 +11Application ANDA075693, ANDA075562, ANDA206543 +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 |
|---|---|---|---|
| 30 pouch in 1 carton / 1 vial, single-dose in 1 pouch / 2.5 mL in 1 vial, single-dose | 65862-905-03 | Aurobindo PharmaIndia | 27 October 2016 |
| 1 pouch in 1 carton / 25 vial, single-dose in 1 pouch / 2.5 mL in 1 vial, single-dose | 65862-905-25 | Aurobindo PharmaIndia | 27 October 2016 |
| 1 pouch in 1 carton / 30 vial, single-dose in 1 pouch / 2.5 mL in 1 vial, single-dose | 65862-905-30 | Aurobindo PharmaIndia | 27 October 2016 |
| 2 pouch in 1 carton / 30 vial, single-dose in 1 pouch / 2.5 mL in 1 vial, single-dose | 65862-905-60 | Aurobindo PharmaIndia | 27 October 2016 |
| 5 pouch in 1 carton / 5 vial in 1 pouch / 2.5 mL in 1 vial | 47335-706-49 | Sun Pharmaceutical IndustriesIndia | 4 February 2020 |
| 6 pouch in 1 carton / 5 vial in 1 pouch / 2.5 mL in 1 vial | 47335-706-52 | Sun Pharmaceutical IndustriesIndia | 4 February 2020 |
| 12 pouch in 1 carton / 5 vial in 1 pouch / 2.5 mL in 1 vial | 47335-706-54 | Sun Pharmaceutical IndustriesIndia | 4 February 2020 |
| 6 pouch in 1 carton / 5 vial in 1 pouch / 2.5 mL in 1 vial | 62135-830-84 | Chartwell RX | 25 January 2024 |
| 1 pouch in 1 carton / 25 ampule in 1 pouch / 2.5 mL in 1 ampule | 0378-7970-52 | Mylan Pharmaceuticals | 9 November 2010 |
| 30 pouch in 1 carton / 1 ampule in 1 pouch / 2.5 mL in 1 ampule | 0378-7970-55 | Mylan Pharmaceuticals | 9 November 2010 |
| 2 pouch in 1 carton / 30 ampule in 1 pouch / 2.5 mL in 1 ampule | 0378-7970-91 | Mylan Pharmaceuticals | 9 November 2010 |
| 1 pouch in 1 carton / 30 ampule in 1 pouch / 2.5 mL in 1 ampule | 0378-7970-93 | Mylan Pharmaceuticals | 9 November 2010 |
| 30 pouch in 1 carton / 1 vial, single-dose in 1 pouch / 2.5 mL in 1 vial, single-dose | 0487-9801-01 | Nephron Pharmaceuticals | 27 September 2001 |
| 30 bag in 1 box / 1 pouch in 1 bag / 1 vial, single-dose in 1 pouch / 2.5 mL in 1 vial, single-dose | 0487-9801-02 | Nephron Pharmaceuticals | 27 September 2001 |
| 1 pouch in 1 carton / 25 vial, single-dose in 1 pouch / 2.5 mL in 1 vial, single-dose | 0487-9801-25 | Nephron Pharmaceuticals | 27 September 2001 |
| 1 pouch in 1 carton / 30 vial, single-dose in 1 pouch / 2.5 mL in 1 vial, single-dose | 0487-9801-30 | Nephron Pharmaceuticals | 27 September 2001 |
| 2 pouch in 1 carton / 30 vial, single-dose in 1 pouch / 2.5 mL in 1 vial, single-dose | 0487-9801-60 | Nephron Pharmaceuticals | 27 September 2001 |
| 1 pouch in 1 carton / 25 vial, single-dose in 1 pouch / 2.5 mL in 1 vial, single-dose | 64980-640-02 | Rising Pharma Holdings | 25 April 2025 |
| 1 pouch in 1 carton / 30 vial, single-dose in 1 pouch / 2.5 mL in 1 vial, single-dose | 64980-640-03 | Rising Pharma Holdings | 25 April 2025 |
| 2 pouch in 1 carton / 30 vial, single-dose in 1 pouch / 2.5 mL in 1 vial, single-dose | 64980-640-06 | Rising Pharma Holdings | 25 April 2025 |
| 30 pouch in 1 carton / 1 ampule in 1 pouch / 2.5 mL in 1 ampule | 76204-100-01 | Ritedose Pharmaceuticals | 21 November 2011 |
| 1 pouch in 1 carton / 25 ampule in 1 pouch / 2.5 mL in 1 ampule | 76204-100-25 | Ritedose Pharmaceuticals | 21 November 2011 |
| 1 pouch in 1 carton / 30 ampule in 1 pouch / 2.5 mL in 1 ampule | 76204-100-30 | Ritedose Pharmaceuticals | 21 November 2011 |
| 2 pouch in 1 carton / 30 ampule in 1 pouch / 2.5 mL in 1 ampule | 76204-100-60 | Ritedose Pharmaceuticals | 21 November 2011 |
| 1 pouch in 1 carton / 25 mL in 1 pouch | 50090-0668-0 | A-S Medication Solutions | 28 November 2014 |
| 25 pouch in 1 carton / 2.5 mL in 1 pouch | 50090-6373-0 | A-S Medication Solutions | 14 February 2023 |
| 5 pouch in 1 bag / 1 ampule in 1 pouch / 2.5 mL in 1 ampule | 55154-2134-5 | Cardinal Health | 26 December 2018 |
| 5 pouch in 1 bag / 1 ampule in 1 pouch / 2.5 mL in 1 ampule | 55154-4411-5 | Cardinal Health | 24 July 2026 |
| 30 pouch in 1 carton / 1 ampule in 1 pouch / 2.5 mL in 1 ampule | 60687-394-83 | American Health Packaging | 7 January 2019 |
| 25 ampule in 1 pouch / 2.5 mL in 1 ampule | 68071-3769-2 | NuCare Pharmaceuticals | 13 January 2025 |
| 1 pouch in 1 carton / 25 ampule in 1 pouch / 2.5 mL in 1 ampule | 67296-2246-1 | Redpharm Drug | 21 November 2011 |
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 29 December 1986 | 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 Ipratropium
Clinical summary
Ipratropium is an anticholinergic indicated as a bronchodilator for maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. It is available as nasal spray, inhalation solution and inhalers. MedsAcross supplies 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 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
- Atrovent HFA prescribing information (Boehringer Ingelheim Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Ipratropium 0.5 mg/2.5 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.