Medicine
Nystatin 100000 units/g cream
Nystatin 100000 units/g cream is a generic prescription medicine for topical use, made by 12 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 20-25°C (68-77°F).
Key facts
- Active ingredient (INN)
- Nystatin
- Brand
- Sold under the generic name
- Strength
- 100000 units/g
- Dosage form
- Cream
- Route
- Topical
- Packs
- 1 tube, 15 g, 30 g and 41 more
- Manufacturers
- Aurobindo PharmaIndiaSun Pharmaceutical IndustriesIndiaTorrent PharmaceuticalsIndiaBryant Ranch PrepackProficient RxA-S Medication SolutionsNuCare Pharmaceuticals,IncCosette PharmaceuticalsCrown LaboratoriesPadagis Israel Pharmaceuticals12 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20-25°C (68-77°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
- 28 January 1993
- Identifiers
- RxCUI 543546DailyMed set ID b69d9035-bdf5-4c5a-94d8-f8438f6f0567, f4c298d5-b012-7b56-e053-2a95a90a3d55, ec1b52af-d38e-eba1-e63c-dba4341d3af2 +27NDC 63629-8695, 67296-1519, 0713-0678 +27Application ANDA062225, ANDA212557, ANDA061966 +4
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
A sample of 41 packs from 12 labelers. The register lists 44 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 tube in 1 carton / 15 g in 1 tube | 59651-907-14 | Aurobindo PharmaIndia | 21 March 2025 |
| 1 tube in 1 carton / 30 g in 1 tube | 59651-907-30 | Aurobindo PharmaIndia | 21 March 2025 |
| 1 tube in 1 carton / 15 g in 1 tube | 51672-1289-1 | Sun Pharmaceutical IndustriesIndia | 28 January 1993 |
| 1 tube in 1 carton / 30 g in 1 tube | 51672-1289-2 | Sun Pharmaceutical IndustriesIndia | 28 January 1993 |
| 15 g in 1 tube | 13668-595-01 | Torrent PharmaceuticalsIndia | 24 July 2019 |
| 30 g in 1 tube | 13668-595-02 | Torrent PharmaceuticalsIndia | 24 July 2019 |
| 1 tube in 1 carton / 15 g in 1 tube | 0713-0678-15 | Cosette Pharmaceuticals | 1 April 2015 |
| 1 tube in 1 carton / 30 g in 1 tube | 0713-0678-31 | Cosette Pharmaceuticals | 1 April 2015 |
| 1 tube in 1 carton / 15 g in 1 tube | 0316-0221-15 | Crown Laboratories | 10 October 2017 |
| 1 tube in 1 carton / 30 g in 1 tube | 0316-0221-30 | Crown Laboratories | 10 October 2017 |
| 1 tube in 1 carton / 30 g in 1 tube | 45802-059-11 | Padagis Israel Pharmaceuticals | 21 September 2006 |
| 1 tube in 1 carton / 15 g in 1 tube | 45802-059-35 | Padagis Israel Pharmaceuticals | 25 January 2007 |
| 1 tube in 1 carton / 15 g in 1 tube | 63629-8694-1 | Bryant Ranch Prepack | 25 January 2007 |
| 1 tube in 1 carton / 30 g in 1 tube | 63629-8695-1 | Bryant Ranch Prepack | 21 September 2006 |
| 1 tube in 1 carton / 30 g in 1 tube | 71335-2830-1 | Bryant Ranch Prepack | 23 October 2025 |
| 1 tube in 1 carton / 15 g in 1 tube | 72162-1385-2 | Bryant Ranch Prepack | 2 April 2025 |
| 1 tube in 1 carton / 30 g in 1 tube | 72162-1385-3 | Bryant Ranch Prepack | 2 April 2025 |
| 1 tube in 1 carton / 15 g in 1 tube | 72162-2496-2 | Bryant Ranch Prepack | 15 May 2025 |
| 1 tube in 1 carton / 30 g in 1 tube | 72162-2496-3 | Bryant Ranch Prepack | 15 May 2025 |
| 15 g in 1 tube | 72162-2576-2 | Bryant Ranch Prepack | 17 November 2025 |
| 30 g in 1 tube | 72162-2576-3 | Bryant Ranch Prepack | 17 November 2025 |
| 1 tube in 1 carton / 30 g in 1 tube | 50090-2763-0 | A-S Medication Solutions | 9 January 2017 |
| 1 tube in 1 carton / 15 g in 1 tube | 50090-2854-0 | A-S Medication Solutions | 8 February 2017 |
| 1 tube in 1 carton / 30 g in 1 tube | 50090-3772-0 | A-S Medication Solutions | 5 November 2018 |
| 1 tube in 1 carton / 15 g in 1 tube | 50090-3799-0 | A-S Medication Solutions | 8 November 2018 |
| 15 g in 1 tube | 50090-7303-0 | A-S Medication Solutions | 14 October 2024 |
| 30 g in 1 box | 66267-952-30 | NuCare Pharmaceuticals,Inc | 24 August 2017 |
| 15 g in 1 box | 66267-953-15 | NuCare Pharmaceuticals,Inc | 18 April 2019 |
| 1 tube in 1 carton / 15 g in 1 tube | 68071-2556-5 | NuCare Pharmaceuticals,Inc | 28 October 2021 |
| 1 tube in 1 carton / 15 g in 1 tube | 68071-3911-5 | NuCare Pharmaceuticals | 6 November 2025 |
| 30 g in 1 box | 68071-4293-3 | NuCare Pharmaceuticals,Inc | 20 February 2018 |
| 1 tube in 1 carton / 15 g in 1 tube | 63187-703-15 | Proficient Rx | 1 June 2016 |
| 1 tube in 1 carton / 30 g in 1 tube | 63187-703-30 | Proficient Rx | 1 June 2016 |
| 1 tube in 1 carton / 15 g in 1 tube | 63187-847-15 | Proficient Rx | 1 May 2017 |
| 1 tube in 1 carton / 30 g in 1 tube | 63187-847-30 | Proficient Rx | 1 May 2017 |
| 1 tube in 1 carton / 30 g in 1 tube | 71205-723-30 | Proficient Rx | 17 November 2022 |
| 15 g in 1 tube | 82804-045-15 | Proficient Rx | 8 December 2023 |
| 30 g in 1 tube | 82804-045-30 | Proficient Rx | 8 December 2023 |
| 1 tube in 1 carton / 15 g in 1 tube | 68788-4099-1 | Preferred Pharmaceuticals | 6 July 2026 |
| 15 g in 1 tube | 68788-8631-1 | Preferred Pharmaceuticals | 15 April 2024 |
| 15 g in 1 box | 72189-278-15 | — | 30 September 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
Alternatives
Other makers and brands of Nystatin 100000 units/g cream.
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 cream 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.