Medicine
Ipratropium 21 mcg nasal spray
Ipratropium 21 mcg nasal spray is a generic prescription medicine for nasal 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
Avoid freezing. Store tightly closed at 20º to 25ºC (68º to 77ºF).
Key facts
- Active ingredient (INN)
- Ipratropium
- Brand
- Sold under the generic name
- Strength
- 21 mcg
- Dosage form
- Nasal spray
- Route
- Nasal
- Packs
- 1 bottle and 6 more
- Manufacturers
- LupinIndiaAdvagen PharmaAmneal Pharmaceuticals NYApotexBausch & LombBryant Ranch PrepackHikma PharmaceuticalsNorthStar RxOceanside Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Avoid freezing. Store tightly closed at 20º to 25ºC (68º to 77ºF).
- 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 March 2003
- Identifiers
- RxCUI 1797833DailyMed set ID 6493c00f-2306-2cb6-9624-4ea678f66576, 61820346-29d9-4864-b8f4-4a198b8ac594, fcf20db7-091d-40de-8755-03773fc47edd +6NDC 16714-526, 69238-2016, 72162-2143 +6Application ANDA076156, ANDA215104, ANDA076664 +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 |
|---|---|---|---|
| 1 bottle, spray in 1 carton / 345 spray, metered in 1 bottle, spray | 70748-336-01 | LupinIndia | 3 July 2025 |
| 1 bottle in 1 carton / 345 spray, metered in 1 bottle | 72888-149-38 | Advagen Pharma | 14 January 2025 |
| 1 bottle, spray in 1 carton / 345 spray in 1 bottle, spray | 69238-2016-3 | Amneal Pharmaceuticals NY | 18 August 2022 |
| 1 bottle, spray in 1 carton / 345 spray, metered in 1 bottle, spray | 60505-0826-1 | Apotex | 26 May 2020 |
| 1 bottle, spray in 1 carton / 345 spray, metered in 1 bottle, spray | 24208-398-30 | Bausch & Lomb | 31 March 2003 |
| 1 bottle, spray in 1 carton / 345 spray in 1 bottle, spray | 0054-0045-44 | Hikma Pharmaceuticals | 5 November 2003 |
| 1 bottle, spray in 1 carton / 345 spray, metered in 1 bottle, spray | 68682-398-30 | Oceanside Pharmaceuticals | 1 June 2025 |
| 1 bottle, spray in 1 carton / 345 spray in 1 bottle, spray | 72162-2143-3 | Bryant Ranch Prepack | 7 December 2023 |
| 1 bottle, spray in 1 carton / 345 spray, metered in 1 bottle, spray | 16714-526-01 | Northstar RX | 22 February 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 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 21 mcg nasal spray 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.