Medicine
Nystatin 100000 units/mL oral suspension
Nystatin 100000 units/mL oral suspension is a generic prescription medicine for oral use, made by 16 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
Avoid freezing. Store at 20° to 25°C (68° to 77°F).
Key facts
- Active ingredient (INN)
- Nystatin
- Brand
- Sold under the generic name
- Strength
- 100000 units/mL
- Dosage form
- Oral suspension
- Route
- Oral
- Packs
- 2 trays, 60 mL, 473 mL and 34 more
- Manufacturers
- Atlantic BiologicalsKesin PharmaPAI PharmaBryant Ranch PrepackXttrium LaboratoriesA-S Medication SolutionsCardinal HealthChartwell RXGenus LifesciencesKanchan Healthcare
- Origin register
- US FDA, United States
- Storage
- Avoid freezing. 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
- 14 April 1971
- Identifiers
- RxCUI 312055DailyMed set ID 4a670371-d373-1ba6-e063-6394a90a13b6, 9954118e-abe6-4388-98c9-4473d39b2e28, 56aca0e2-8691-4701-beba-e2315524709f +17NDC 0116-4026, 62135-813, 55154-4314 +16Application ANDA062512, NDA050299, ANDA203621 +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 |
|---|---|---|---|
| 2 tray in 1 box / 10 cup in 1 tray / 5 mL in 1 cup | 68999-813-24 | Chartwell Governmental & Specialty RX | 7 November 2025 |
| 60 mL in 1 bottle | 62135-813-46 | Chartwell RX | 27 June 2024 |
| 473 mL in 1 bottle | 62135-813-47 | Chartwell RX | 10 April 2024 |
| 60 mL in 1 bottle, dropper | 64950-372-06 | Genus Lifesciences | 11 May 2026 |
| 473 mL in 1 bottle | 64950-372-47 | Genus Lifesciences | 24 March 2026 |
| 1 bottle in 1 carton / 60 mL in 1 bottle | 85742-013-10 | Kanchan Healthcare | 12 September 2025 |
| 473 mL in 1 bottle | 85742-013-11 | Kanchan Healthcare | 12 September 2025 |
| 473 mL in 1 bottle | 69315-504-47 | Leading Pharma | 5 December 2022 |
| 1 bottle in 1 package / 60 mL in 1 bottle | 69315-504-60 | Leading Pharma | 5 December 2022 |
| 10 tray in 1 case / 10 cup, unit-dose in 1 tray / 5 mL in 1 cup, unit-dose | 0121-0868-00 | PAI Pharma | 17 July 2020 |
| 60 mL in 1 bottle, dropper | 0121-0868-02 | PAI Pharma | 17 July 2020 |
| 473 mL in 1 bottle | 0121-0868-16 | PAI Pharma | 17 July 2020 |
| 5 tray in 1 case / 10 cup, unit-dose in 1 tray / 5 mL in 1 cup, unit-dose | 0121-0868-50 | PAI Pharma | 17 July 2020 |
| 10 tray in 1 case / 10 cup, unit-dose in 1 tray / 5 mL in 1 cup, unit-dose | 0116-4026-11 | Xttrium Laboratories | 6 February 2026 |
| 473 mL in 1 bottle, plastic | 0116-4026-16 | Xttrium Laboratories | 9 February 2026 |
| 5 tray in 1 case / 10 cup, unit-dose in 1 tray / 5 mL in 1 cup, unit-dose | 0116-4026-50 | Xttrium Laboratories | 9 February 2026 |
| 60 mL in 1 bottle, glass | 50090-1740-0 | A-S Medication Solutions | 12 March 2015 |
| 60 mL in 1 bottle, dropper | 50090-5315-0 | A-S Medication Solutions | 29 October 2020 |
| 473 mL in 1 bottle | 63629-8520-1 | Bryant Ranch Prepack | 19 May 2021 |
| 473 mL in 1 bottle | 72162-2645-2 | Bryant Ranch Prepack | 11 May 2026 |
| 1 bottle in 1 carton / 60 mL in 1 bottle | 72162-2645-6 | Bryant Ranch Prepack | 11 May 2026 |
| 5 cup, unit-dose in 1 bag / 5 mL in 1 cup, unit-dose | 55154-4314-5 | Cardinal Health | 1 August 2023 |
| 5 cup, unit-dose in 1 bag / 5 mL in 1 cup, unit-dose | 55154-5788-5 | Cardinal Health | 17 July 2020 |
| 100 cup, unit-dose in 1 case / 5 mL in 1 cup, unit-dose | 81033-015-01 | Kesin Pharma | 24 November 2025 |
| 473 mL in 1 bottle | 81033-015-16 | Kesin Pharma | 30 June 2026 |
| 50 cup, unit-dose in 1 carton / 5 mL in 1 cup, unit-dose | 81033-015-54 | Kesin Pharma | 24 November 2025 |
| 1 bottle in 1 carton / 60 mL in 1 bottle | 81033-015-60 | Kesin Pharma | 31 August 2026 |
| 10 tray in 1 case / 10 cup, unit-dose in 1 tray / 5 mL in 1 cup, unit-dose | 60687-800-17 | American Health Packaging | 26 February 2024 |
| 72 cup, unit-dose in 1 box, unit-dose / 5 mL in 1 cup, unit-dose | 17856-0508-1 | Atlantic Biologicals | 15 July 2024 |
| 48 syringe in 1 box, unit-dose / 5 mL in 1 syringe | 17856-0508-3 | Atlantic Biologicals | 17 July 2024 |
| 48 syringe in 1 box, unit-dose / 5 mL in 1 syringe | 17856-0508-5 | Atlantic Biologicals | 17 July 2024 |
| 120 syringe in 1 box, unit-dose / 1 mL in 1 syringe | 17856-0508-7 | Atlantic Biologicals | 17 July 2024 |
| 10 tray in 1 case / 10 cup, unit-dose in 1 tray / 5 mL in 1 cup, unit-dose | 0904-7276-70 | Major Pharmaceuticals | 28 November 2022 |
| 5 tray in 1 case / 10 cup, unit-dose in 1 tray / 5 mL in 1 cup, unit-dose | 0904-7276-92 | Major Pharmaceuticals | 28 November 2022 |
| 1 bottle in 1 package / 60 mL in 1 bottle | 68071-3543-6 | NuCare Pharmaceuticals,Inc | 29 November 2023 |
| 473 mL in 1 bottle | 68788-8561-4 | Preferred Pharmaceuticals | 8 January 2024 |
| 60 mL in 1 bottle | 68788-8561-6 | Preferred Pharmaceuticals | 8 January 2024 |
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/mL oral suspension 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.