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Nystop 100000 units/g topical powder

Nystatin · Topical · Padagis
Available on requestPrescription onlyUS FDA

Nystop 100000 units/g topical powder is a prescription medicine containing Nystatin for topical use, marketed by Padagis, 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

Available on request

Export supply from India to licensed buyers

Typical lead time

On request

Counted from payment and complete documents

Shipping

Ambient

Store at controlled room temperature 15°-30°C (59°-86°F), avoid excessive heat…

Key facts

Active ingredient (INN)
Nystatin
Brand
Nystop
Strength
100000 units/g
Dosage form
Topical powder
Route
Topical
Packs
60 g, 15 g, 30 g and 8 more
Marketing authorisation holder
Padagis
Manufacturers
PadagisBryant Ranch Prepack
Origin register
US FDA, United States
Storage
Store at controlled room temperature 15°-30°C (59°-86°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
16 August 1996
Identifiers
RxCUI 261178, 646456DailyMed set ID 69ebb4dd-f45d-448d-97cd-3f8935493975, e1b4622c-0f9f-4c00-b42c-2aa85a5e3d4f, affea013-4f09-4e7d-a696-9f501d379af6 +4NDC 63629-8698, 0574-2008, 71335-2869 +4Application ANDA064118

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

PackCodeLabelerMarketed since
60 g in 1 bottle, plastic0574-2008-02Padagis16 August 1996
15 g in 1 bottle, plastic0574-2008-15Padagis16 August 1996
30 g in 1 bottle, plastic0574-2008-30Padagis16 August 1996
15 g in 1 bottle, plastic63629-8696-1Bryant Ranch Prepack16 August 1996
30 g in 1 bottle, plastic63629-8697-1Bryant Ranch Prepack16 August 1996
60 g in 1 bottle, plastic63629-8698-1Bryant Ranch Prepack16 August 1996
15 g in 1 bottle, plastic71335-2845-1Bryant Ranch Prepack21 October 2025
30 g in 1 bottle, plastic71335-2869-1Bryant Ranch Prepack21 October 2025
15 g in 1 bottle, plastic72162-1124-2Bryant Ranch Prepack24 December 2024
30 g in 1 bottle, plastic72162-1124-3Bryant Ranch Prepack24 December 2024
60 g in 1 bottle, plastic72162-1124-6Bryant Ranch Prepack24 December 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.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 14 April 1971Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS 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.

Compare all 3

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 Nystatin

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

Need Nystop 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.