Medicine
Nystatin 100000 units/g ointment
Nystatin 100000 units/g ointment is a generic prescription medicine for topical use, made by 10 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 room temperature.
Key facts
- Active ingredient (INN)
- Nystatin
- Brand
- Sold under the generic name
- Strength
- 100000 units/g
- Dosage form
- Ointment
- Route
- Topical
- Packs
- 15 g, 30 g, 1 tube and 20 more
- Manufacturers
- Torrent PharmaceuticalsIndiaViona PharmaceuticalsIndiaZydus LifesciencesIndiaBryant Ranch PrepackActavis PharmaCosette PharmaceuticalsLeading PharmaPadagis Israel PharmaceuticalsProficient RxA-S Medication Solutions
- Origin register
- US FDA, United States
- Storage
- Store at room temperature.
- 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
- 3 September 2002
- Identifiers
- RxCUI 884308DailyMed set ID 6a3bb3da-adf9-46d2-a5ff-f796e7aae7a1, 93d59122-86f3-489d-9790-1ef6c6aff89d, 72dc2b60-29a4-48a8-848a-1a5086cfdd58 +10NDC 50090-5845, 72162-2007, 72162-2333 +11Application ANDA207767, ANDA062472, ANDA209114 +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 |
|---|---|---|---|
| 15 g in 1 tube | 13668-534-01 | Torrent PharmaceuticalsIndia | 29 January 2019 |
| 30 g in 1 tube | 13668-534-02 | Torrent PharmaceuticalsIndia | 29 January 2019 |
| 15 g in 1 tube | 72578-089-01 | Viona PharmaceuticalsIndia | 24 June 2020 |
| 30 g in 1 tube | 72578-089-04 | Viona PharmaceuticalsIndia | 24 June 2020 |
| 15 g in 1 tube | 70771-1357-1 | Zydus LifesciencesIndia | 8 August 2018 |
| 30 g in 1 tube | 70771-1357-2 | Zydus LifesciencesIndia | 8 August 2018 |
| 1 tube in 1 carton / 15 g in 1 tube | 0472-0166-15 | Actavis Pharma | 3 September 2002 |
| 1 tube in 1 carton / 30 g in 1 tube | 0472-0166-30 | Actavis Pharma | 3 September 2002 |
| 1 tube in 1 carton / 15 g in 1 tube | 0713-0686-15 | Cosette Pharmaceuticals | 30 July 2018 |
| 1 tube in 1 carton / 30 g in 1 tube | 0713-0686-31 | Cosette Pharmaceuticals | 30 July 2018 |
| 1 tube in 1 carton / 15 g in 1 tube | 69315-307-15 | Leading Pharma | 19 August 2019 |
| 1 tube in 1 carton / 30 g in 1 tube | 69315-307-30 | Leading Pharma | 19 August 2019 |
| 1 tube in 1 carton / 30 g in 1 tube | 45802-048-11 | Padagis Israel Pharmaceuticals | 8 November 2006 |
| 1 tube in 1 carton / 15 g in 1 tube | 45802-048-35 | Padagis Israel Pharmaceuticals | 15 September 2006 |
| 30 g in 1 tube | 63629-2515-1 | Bryant Ranch Prepack | 18 May 2021 |
| 15 g in 1 tube | 63629-2516-1 | Bryant Ranch Prepack | 18 May 2021 |
| 15 g in 1 tube | 72162-2007-2 | Bryant Ranch Prepack | 6 February 2024 |
| 30 g in 1 tube | 72162-2007-3 | Bryant Ranch Prepack | 6 February 2024 |
| 1 tube in 1 carton / 15 g in 1 tube | 72162-2333-2 | Bryant Ranch Prepack | 18 June 2024 |
| 1 tube in 1 carton / 30 g in 1 tube | 72162-2333-3 | Bryant Ranch Prepack | 18 June 2024 |
| 1 tube in 1 carton / 15 g in 1 tube | 63187-464-15 | Proficient Rx | 1 January 2019 |
| 1 tube in 1 carton / 15 g in 1 tube | 71205-437-15 | Proficient Rx | 19 March 2020 |
| 15 g in 1 tube | 50090-5845-0 | A-S Medication Solutions | 4 November 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 100000 units/g ointment 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.