nystop

Generic: nystatin

Labeler: padagis us llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nystop
Generic Name nystatin
Labeler padagis us llc
Dosage Form POWDER
Routes
TOPICAL
Active Ingredients

nystatin 100000 [USP'U]/g

Manufacturer
Padagis US LLC

Identifiers & Regulatory

Product NDC 0574-2008
Product ID 0574-2008_ef93a977-5107-4b0b-8d58-df221d7777db
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA064118
Listing Expiration 2026-12-31
Marketing Start 1996-08-16

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05742008
Hyphenated Format 0574-2008

Supplemental Identifiers

RxCUI
261178 646456
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 nystop (source: ndc)
Generic Name nystatin (source: ndc)
Application Number ANDA064118 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 100000 [USP'U]/g
source: ndc
Packaging
  • 60 g in 1 BOTTLE, PLASTIC (0574-2008-02)
  • 15 g in 1 BOTTLE, PLASTIC (0574-2008-15)
  • 30 g in 1 BOTTLE, PLASTIC (0574-2008-30)
source: ndc

Packages (3)

0574-2008-02 60 g in 1 BOTTLE, PLASTIC (0574-2008-02) 0574-2008-15 15 g in 1 BOTTLE, PLASTIC (0574-2008-15) 0574-2008-30 30 g in 1 BOTTLE, PLASTIC (0574-2008-30)

Ingredients (1)

nystatin (100000 [USP'U]/g)

Linked Drug Pages (1)

Nystop ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "ef93a977-5107-4b0b-8d58-df221d7777db", "openfda": {"nui": ["N0000175498", "M0017172"], "unii": ["BDF1O1C72E"], "rxcui": ["261178", "646456"], "spl_set_id": ["e1b4622c-0f9f-4c00-b42c-2aa85a5e3d4f"], "pharm_class_cs": ["Polyenes [CS]"], "pharm_class_epc": ["Polyene Antifungal [EPC]"], "manufacturer_name": ["Padagis US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 g in 1 BOTTLE, PLASTIC (0574-2008-02)", "package_ndc": "0574-2008-02", "marketing_start_date": "19960816"}, {"sample": false, "description": "15 g in 1 BOTTLE, PLASTIC (0574-2008-15)", "package_ndc": "0574-2008-15", "marketing_start_date": "19960816"}, {"sample": false, "description": "30 g in 1 BOTTLE, PLASTIC (0574-2008-30)", "package_ndc": "0574-2008-30", "marketing_start_date": "19960816"}], "brand_name": "Nystop", "product_id": "0574-2008_ef93a977-5107-4b0b-8d58-df221d7777db", "dosage_form": "POWDER", "pharm_class": ["Polyene Antifungal [EPC]", "Polyenes [CS]"], "product_ndc": "0574-2008", "generic_name": "Nystatin", "labeler_name": "Padagis US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nystop", "active_ingredients": [{"name": "NYSTATIN", "strength": "100000 [USP'U]/g"}], "application_number": "ANDA064118", "marketing_category": "ANDA", "marketing_start_date": "19960816", "listing_expiration_date": "20261231"}