Medicine
Nystatin 500000 units tablet
Nystatin 500000 units tablet is a generic prescription medicine for oral use, made by 8 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° to 25°C (68° to 77°F).
Key facts
- Active ingredient (INN)
- Nystatin
- Brand
- Sold under the generic name
- Strength
- 500000 units
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 90 tablets, 28 tablets and 10 more
- Manufacturers
- Avet PharmaceuticalsIndiaBryant Ranch PrepackProficient RxAvKAREChartwell RXNuCare Pharmaceuticals,IncPreferred PharmaceuticalsTeva Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°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
- 30 September 1990
- Identifiers
- RxCUI 312059DailyMed set ID 05cc72dd-8e05-bfb5-e063-6394a90a92f1, e87b8480-987d-4f82-87bf-cf831d6984a1, f03b294d-10cd-4bba-92c8-42ae9b110cd0 +5NDC 68071-3508, 23155-051, 0093-0983 +5Application ANDA062474, ANDA062506
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 |
|---|---|---|---|
| 100 tablet, coated in 1 bottle | 23155-051-01 | Avet PharmaceuticalsIndia | 31 October 2011 |
| 90 tablet, film coated in 1 bottle | 62135-741-90 | Chartwell RX | 8 August 2023 |
| 100 tablet, film coated in 1 bottle | 0093-0983-01 | Teva Pharmaceuticals | 30 September 1990 |
| 90 tablet, film coated in 1 bottle | 42291-651-90 | AvKARE | 20 January 2014 |
| 28 tablet, coated in 1 bottle | 63629-8350-1 | Bryant Ranch Prepack | 29 April 2022 |
| 56 tablet, coated in 1 bottle | 63629-8350-2 | Bryant Ranch Prepack | 2 September 2020 |
| 30 tablet, coated in 1 bottle | 63629-8350-3 | Bryant Ranch Prepack | 2 September 2020 |
| 120 tablet, coated in 1 bottle | 63629-8350-4 | Bryant Ranch Prepack | 7 June 2024 |
| 90 tablet, coated in 1 bottle | 68071-3508-9 | NuCare Pharmaceuticals,Inc | 20 September 2023 |
| 120 tablet, coated in 1 bottle | 68788-8690-1 | Preferred Pharmaceuticals | 7 June 2024 |
| 30 tablet, coated in 1 bottle | 71205-575-30 | Proficient Rx | 8 June 2021 |
| 60 tablet, coated in 1 bottle | 71205-575-60 | Proficient Rx | 8 June 2021 |
| 90 tablet, coated in 1 bottle | 71205-575-90 | Proficient Rx | 8 June 2021 |
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
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 500000 units tablet 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.