Medicine
Nystatin 100000 units/g topical powder
Nystatin 100000 units/g topical powder is a generic prescription medicine for topical use, made by 5 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°C to 25°C (68°F to 77°F), avoid excessive heat (40°C/104°F).
Key facts
- Active ingredient (INN)
- Nystatin
- Brand
- Sold under the generic name
- Strength
- 100000 units/g
- Dosage form
- Topical powder
- Route
- Topical
- Packs
- 15 g, 30 g, 60 g and 18 more
- Manufacturers
- Zydus LifesciencesIndiaDr. Reddy's LaboratoriesIndiaEpic PharmaLeading PharmaNorthStar Rx
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F), avoid excessive heat (40°C/104°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- A07AA02 Nystatin
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 23 April 2018
- Identifiers
- RxCUI 646456DailyMed set ID fb2a480e-0bb1-445e-bbb6-701dea6dc631, 2daf159d-6a12-4b5d-97b3-8069c17e7635, 5d593aa9-f2e4-4adf-9f02-37832ffcb5b4 +4NDC 42806-185, 68382-370, 70771-1585 +4Application ANDA210532, ANDA208581, ANDA064118 +2
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 |
|---|---|---|---|
| 15 g in 1 bottle, plastic | 68382-370-01 | Zydus LifesciencesIndia | 6 October 2021 |
| 30 g in 1 bottle, plastic | 68382-370-02 | Zydus LifesciencesIndia | 6 October 2021 |
| 60 g in 1 bottle, plastic | 68382-370-03 | Zydus LifesciencesIndia | 6 October 2021 |
| 15 g in 1 bottle, plastic | 70771-1585-1 | Zydus LifesciencesIndia | 6 October 2021 |
| 30 g in 1 bottle, plastic | 70771-1585-2 | Zydus LifesciencesIndia | 6 October 2021 |
| 60 g in 1 bottle, plastic | 70771-1585-3 | Zydus LifesciencesIndia | 6 October 2021 |
| 30 g in 1 bottle, plastic | 75907-060-30 | Dr. Reddy's LaboratoriesIndia | 28 May 2024 |
| 15 g in 1 bottle, plastic | 75907-060-44 | Dr. Reddy's LaboratoriesIndia | 28 May 2024 |
| 60 g in 1 bottle, plastic | 75907-060-60 | Dr. Reddy's LaboratoriesIndia | 28 May 2024 |
| 15 g in 1 bottle | 42806-178-15 | Epic Pharma | 2 May 2018 |
| 30 g in 1 bottle | 42806-178-30 | Epic Pharma | 2 May 2018 |
| 60 g in 1 bottle | 42806-178-60 | Epic Pharma | 2 May 2018 |
| 15 g in 1 bottle | 42806-185-15 | Epic Pharma | 14 April 2023 |
| 30 g in 1 bottle | 42806-185-30 | Epic Pharma | 14 April 2023 |
| 60 g in 1 bottle | 42806-185-60 | Epic Pharma | 14 April 2023 |
| 15 g in 1 bottle, plastic | 69315-306-15 | Leading Pharma | 23 April 2018 |
| 30 g in 1 bottle, plastic | 69315-306-30 | Leading Pharma | 23 April 2018 |
| 60 g in 1 bottle, plastic | 69315-306-60 | Leading Pharma | 23 April 2018 |
| 15 g in 1 bottle, plastic | 72603-491-01 | Northstar Rx | 1 September 2025 |
| 30 g in 1 bottle, plastic | 72603-491-02 | Northstar Rx | 1 September 2025 |
| 60 g in 1 bottle, plastic | 72603-491-03 | Northstar Rx | 1 September 2025 |
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 14 April 1971 | 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
Alternatives
Other makers and brands of Nystatin 100000 units/g topical powder.
Other strengths and forms of Nystatin
Clinical summary
Nystatin is a polyene antifungal indicated for the treatment of infections of the oral cavity caused by Candida albicans. It is available as cream, oral suspension and topical powder. MedsAcross supplies Nystatin 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 NystatinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Nystatin prescribing information (Chartwell RX) · U.S. National Library of Medicine, DailyMed
Need Nystatin 100000 units/g topical powder 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.