Medicine
Mannitol and Sorbitol 0.54 g/2.7 g per 100 mL irrigation solution
Mannitol and Sorbitol 0.54 g/2.7 g per 100 mL irrigation solution is a generic prescription medicine for urethral use, 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
Protect from freezing. Store at 20 to 25ºC (68 to 77ºF).
Key facts
- Active ingredient (INN)
- Mannitol and Sorbitol
- Brand
- Sold under the generic name
- Strength
- 0.54 g/2.7 g per 100 mL
- Dosage form
- Irrigation solution
- Route
- Urethral
- Packs
- 4 pouches
- Manufacturer
- ICU Medical
- Origin register
- US FDA, United States
- Storage
- Protect from freezing. Store at 20 to 25ºC (68 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
- 1 October 2019
- Identifiers
- RxCUI 311446DailyMed set ID 5b44e248-4b7b-4777-954a-921c7b309944NDC 0990-7981Application NDA018316
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 4 pouch in 1 case / 1 bag in 1 pouch / 3000 mL in 1 bag | 0990-7981-08 | ICU Medical | 1 October 2019 |
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 21 June 1976 | 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
Clinical summary
Mannitol and Sorbitol is a fixed-dose combination medicine indicated as a urologic irrigating fluid during transurethral prostatic resection and other transurethral surgical procedures. It is available as irrigation solution for urethral use. MedsAcross supplies Mannitol and Sorbitol 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 Mannitol and SorbitolFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Sorbitol-Mannitol prescribing information (ICU Medical) · U.S. National Library of Medicine, DailyMed
Need Mannitol and Sorbitol 0.54 g/2.7 g per 100 mL irrigation 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.