Active ingredient
Nystatin
93 finished FDA listings contain Nystatin as their only active ingredient; 36 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- NYSTATIN
- Dosage forms
- Cream, Ointment, Powder, Suspension, Tablet, Coated, Tablet, Film Coated
- Routes
- Oral, Topical
- Manufacturers / labelers
- 41
- Strengths listed
- 100000 [usp'u]/g · 100000 [usp'u]/ml · 100000 1/g · 100000 u/g · 100000 u/ml · 500000 [usp'u]/1
- Brand names in FDA listings
- Klayesta, Mycostatin, Nyamyc, Nystatin, Nystatin Oral Suspension, Nystop
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 7597
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 050299 | CHARTWELL MOLECULES | 1971-04-14 | 2 |
| ANDA 061966 | COSETTE PHARMS NC | 1976-05-25 | 5 |
| ANDA 062225 | PADAGIS US | 1979-12-11 | 11 |
| ANDA 062474 | HERITAGE | 1983-12-22 | 6 |
| ANDA 062506 | TEVA | 1984-01-16 | 2 |
| ANDA 062472 | PADAGIS US | 1984-02-13 | 2 |
| ANDA 062512 | PHARMOBEDIENT | 1984-10-29 | 2 |
| ANDA 062840 | ACTAVIS MID ATLANTIC | 1987-11-13 | 2 |
| ANDA 062832 | SCIEGEN PHARMS | 1991-12-27 | 5 |
| ANDA 064022 | SUN PHARMA CANADA | 1993-01-29 | 5 |
| ANDA 064118 | PADAGIS US | 1996-08-16 | 8 |
| ANDA 065203 | DR REDDYS LABS SA | 2004-07-15 | 1 |
| ANDA 065183 | UPSHER SMITH LABS | 2005-05-03 | 1 |
| ANDA 065148 | GENUS | 2005-06-28 | 1 |
| ANDA 203621 | PHARM ASSOC | 2016-01-07 | 8 |
| ANDA 208838 | LYNE | 2017-05-30 | 1 |
| ANDA 208581 | ZYDUS PHARMS | 2017-06-08 | 2 |
| ANDA 207733 | CROWN LABS INC | 2017-09-26 | 1 |
| ANDA 209114 | COSETTE | 2017-10-06 | 2 |
| ANDA 210532 | EPIC PHARMA LLC | 2018-04-30 | 3 |
| ANDA 209082 | LYNE | 2018-05-21 | 1 |
| ANDA 207767 | ZYDUS LIFESCIENCES | 2018-05-25 | 6 |
| ANDA 211838 | TORRENT | 2019-01-28 | 1 |
| ANDA 212557 | TORRENT | 2019-07-24 | 6 |
| ANDA 213826 | MACLEODS PHARMS | 2021-01-14 | 1 |
| ANDA 213566 | MACLEODS PHARMS | 2021-08-10 | 3 |
| ANDA 214346 | SENORES PHARMS | 2022-03-10 | 4 |
| ANDA 219527 | AUROBINDO PHARMA | 2025-03-21 | 1 |
Official labeling on DailyMed
- NYSTOP (NYSTATIN) POWDER [PADAGIS US LLC] · version 11 · 2026-08-26
- NYSTATIN TABLET, COATED [NUCARE PHARMACEUTICALS,INC.] · version 2 · 2026-08-20
- NYSTATIN CREAM [PREFERRED PHARMACEUTICALS INC.] · version 1 · 2026-08-11
- NYSTATIN TABLET, COATED [PREFERRED PHARMACEUTICALS INC.] · version 3 · 2026-08-07
- NYSTATIN SUSPENSION [PREFERRED PHARMACEUTICALS INC.] · version 3 · 2026-08-07
- NYSTATIN CREAM [PREFERRED PHARMACEUTICALS INC.] · version 3 · 2026-08-06
- NYSTATIN (NYSTATIN) CREAM [A-S MEDICATION SOLUTIONS] · version 3 · 2026-07-27
- NYSTATIN SUSPENSION [PAI HOLDINGS, LLC DBA PAI PHARMA] · version 9 · 2026-07-24
- NYSTOP (NYSTATIN) POWDER [BRYANT RANCH PREPACK] · version 103 · 2026-07-15
- NYSTATIN CREAM [BRYANT RANCH PREPACK] · version 101 · 2026-07-13
- NYSTATIN SUSPENSION [KESIN PHARMA CORPORATION] · version 1 · 2026-06-01
- NYSTATIN SUSPENSION [BRYANT RANCH PREPACK] · version 100 · 2026-05-13
Showing the 12 most recent of 92 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.