Home NDC 42806-186 KLAYESTA
Product NDC 42806-186
11-digit product format 428060186
Labeler code 42806
Product ID 42806-186_d8220de7-25d0-46ba-b5a0-8f2f35bd5323
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nystatin Topical Powder
Dosage form POWDER
Route TOPICAL
Labeler Epic Pharma, LLC
Application ANDA210532
Marketing category ANDA
Marketing start 2023-04-14
Substance NYSTATIN
Active strength 100000 U/g
Pharmacologic classes Polyene Antifungal [EPC], Polyenes [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A210532-001 KLAYESTA NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT 2018-04-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210532-001 AT
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A210532-001 KLAYESTA 100,000 UNITS/GM POWDER / TOPICAL AT 2018-04-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210532-001 KLAYESTA 100,000 UNITS/GM POWDER / TOPICAL AT 2018-04-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210532-001 KLAYESTA 100,000 UNITS/GM POWDER / TOPICAL AT 2018-04-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210532-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT 2018-04-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210532-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT 2018-04-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210532-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT 2018-04-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210532-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT 2018-04-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210532-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT 2018-04-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210532-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT 2018-04-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210532-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT 2018-04-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210532-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT 2018-04-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210532-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT 2018-04-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210532-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT 2018-04-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210532-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT 2018-04-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210532-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT 2018-04-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210532-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT 2018-04-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210532-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT 2018-04-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210532-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT 2018-04-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A210532-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT 2018-04-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A210532-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT 2018-04-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210532-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT 2018-04-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210532-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT 2018-04-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210532-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT 2018-04-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A210532-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT 2018-04-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A210532-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT 2018-04-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A210532-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT 2018-04-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A210532-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT 2018-04-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A210532-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT 2018-04-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210532-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT 2018-04-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210532-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT 2018-04-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210532-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT 2018-04-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210532-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT 2018-04-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210532-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT 2018-04-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210532-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT 2018-04-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210532-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT 2018-04-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210532-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT 2018-04-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210532-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT 2018-04-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210532-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT 2018-04-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A210532-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT 2018-04-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A210532-001 NYSTATIN 100,000 UNITS/GM POWDER / TOPICAL AT 2018-04-30 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base KLAYESTA
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NYSTATIN 100000 U/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination BDF1O1C72E Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 646456 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42806-186-15 KLAYESTA 15 g in 1 BOTTLE POWDER 15 3 42806-186-30 KLAYESTA 30 g in 1 BOTTLE POWDER 30 3 42806-186-60 KLAYESTA 60 g in 1 BOTTLE POWDER 60 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42806-186 KLAYESTA (NYSTATIN TOPICAL POWDER) POWDER [EPIC PHARMA, LLC] 2 Current NDC, 3 package rows 20241222_0df13b1e-0e07-4123-a83a-1d7afb56170f.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 42806-186-15 42806018615 15 g in 1 BOTTLE (42806-186-15) 15 g 2023-04-14 No No Current 42806-186-30 42806018630 30 g in 1 BOTTLE (42806-186-30) 30 g 2023-04-14 No No Current 42806-186-60 42806018660 60 g in 1 BOTTLE (42806-186-60) 60 g 2023-04-14 No No Current