nystatin topical powder (42806-185)

Drug Facts

Product Profile

Brand Name nystatin topical powder

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 42806-185

Product ID 42806-185_8723c280-f501-46c5-8be5-8a3e9cbd28b9

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 42806185

Hyphenated Format 42806-185

Supplemental Identifiers

RxCUI

646456

UPC

0342806185605 0342806185155 0342806185308

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 nystatin topical powder (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 (42806-185-15)
30 g in 1 BOTTLE (42806-185-30)
60 g in 1 BOTTLE (42806-185-60)

source: ndc

Packages (3)

42806-185-15 15 g in 1 BOTTLE (42806-185-15) 42806-185-30 30 g in 1 BOTTLE (42806-185-30) 42806-185-60 60 g in 1 BOTTLE (42806-185-60)

Ingredients (1)

nystatin (100000 U/g)

Linked Drug Pages (1)

Nystatin Topical Powder ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["TOPICAL"], "spl_id": "8723c280-f501-46c5-8be5-8a3e9cbd28b9", "openfda": {"nui": ["N0000175498", "M0017172"], "upc": ["0342806185605", "0342806185155", "0342806185308"], "unii": ["BDF1O1C72E"], "rxcui": ["646456"], "spl_set_id": ["fb2a480e-0bb1-445e-bbb6-701dea6dc631"], "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 (42806-185-15)", "package_ndc": "42806-185-15", "marketing_start_date": "20230414"}, {"sample": false, "description": "30 g in 1 BOTTLE (42806-185-30)", "package_ndc": "42806-185-30", "marketing_start_date": "20230414"}, {"sample": false, "description": "60 g in 1 BOTTLE (42806-185-60)", "package_ndc": "42806-185-60", "marketing_start_date": "20230414"}], "brand_name": "Nystatin Topical Powder", "product_id": "42806-185_8723c280-f501-46c5-8be5-8a3e9cbd28b9", "dosage_form": "POWDER", "pharm_class": ["Polyene Antifungal [EPC]", "Polyenes [CS]"], "product_ndc": "42806-185", "generic_name": "Nystatin Topical Powder", "labeler_name": "Epic Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nystatin Topical Powder", "active_ingredients": [{"name": "NYSTATIN", "strength": "100000 U/g"}], "application_number": "ANDA210532", "marketing_category": "ANDA", "marketing_start_date": "20230414", "listing_expiration_date": "20261231"}