klayesta

Generic: nystatin topical powder

Labeler: epic pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name klayesta
Generic Name nystatin topical powder
Labeler epic pharma, llc
Dosage Form POWDER
Routes
TOPICAL
Active Ingredients

nystatin 100000 U/g

Manufacturer
Epic Pharma, LLC

Identifiers & Regulatory

Product NDC 42806-186
Product ID 42806-186_d8220de7-25d0-46ba-b5a0-8f2f35bd5323
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210532
Listing Expiration 2026-12-31
Marketing Start 2023-04-14

Pharmacologic Class

Established (EPC)
polyene antifungal [epc]
Chemical Structure
polyenes [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42806186
Hyphenated Format 42806-186

Supplemental Identifiers

RxCUI
646456
UPC
0342806186305 0342806186152
UNII
BDF1O1C72E
NUI
N0000175498 M0017172

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name klayesta (source: ndc)
Generic Name nystatin topical powder (source: ndc)
Application Number ANDA210532 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 100000 U/g
source: ndc
Packaging
  • 15 g in 1 BOTTLE (42806-186-15)
  • 30 g in 1 BOTTLE (42806-186-30)
  • 60 g in 1 BOTTLE (42806-186-60)
source: ndc

Packages (3)

42806-186-15 15 g in 1 BOTTLE (42806-186-15) 42806-186-30 30 g in 1 BOTTLE (42806-186-30) 42806-186-60 60 g in 1 BOTTLE (42806-186-60)

Ingredients (1)

nystatin (100000 U/g)

Linked Drug Pages (1)

KLAYESTA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "d8220de7-25d0-46ba-b5a0-8f2f35bd5323", "openfda": {"nui": ["N0000175498", "M0017172"], "upc": ["0342806186305", "0342806186152"], "unii": ["BDF1O1C72E"], "rxcui": ["646456"], "spl_set_id": ["0df13b1e-0e07-4123-a83a-1d7afb56170f"], "pharm_class_cs": ["Polyenes [CS]"], "pharm_class_epc": ["Polyene Antifungal [EPC]"], "manufacturer_name": ["Epic Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "15 g in 1 BOTTLE (42806-186-15)", "package_ndc": "42806-186-15", "marketing_start_date": "20230414"}, {"sample": false, "description": "30 g in 1 BOTTLE (42806-186-30)", "package_ndc": "42806-186-30", "marketing_start_date": "20230414"}, {"sample": false, "description": "60 g in 1 BOTTLE (42806-186-60)", "package_ndc": "42806-186-60", "marketing_start_date": "20230414"}], "brand_name": "KLAYESTA", "product_id": "42806-186_d8220de7-25d0-46ba-b5a0-8f2f35bd5323", "dosage_form": "POWDER", "pharm_class": ["Polyene Antifungal [EPC]", "Polyenes [CS]"], "product_ndc": "42806-186", "generic_name": "Nystatin Topical Powder", "labeler_name": "Epic Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "KLAYESTA", "active_ingredients": [{"name": "NYSTATIN", "strength": "100000 U/g"}], "application_number": "ANDA210532", "marketing_category": "ANDA", "marketing_start_date": "20230414", "listing_expiration_date": "20261231"}