nystatin

Generic: nystatin

Labeler: padagis israel pharmaceuticals ltd
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nystatin
Generic Name nystatin
Labeler padagis israel pharmaceuticals ltd
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

nystatin 100000 [USP'U]/g

Manufacturer
Padagis Israel Pharmaceuticals Ltd

Identifiers & Regulatory

Product NDC 45802-059
Product ID 45802-059_e2839c50-5b8f-4e7b-9636-d22687038a89
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA062225
Listing Expiration 2026-12-31
Marketing Start 2006-09-21

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 45802059
Hyphenated Format 45802-059

Supplemental Identifiers

RxCUI
543546
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 (source: ndc)
Generic Name nystatin (source: ndc)
Application Number ANDA062225 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 100000 [USP'U]/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (45802-059-11) / 30 g in 1 TUBE
  • 1 TUBE in 1 CARTON (45802-059-35) / 15 g in 1 TUBE
source: ndc

Packages (2)

45802-059-11 1 TUBE in 1 CARTON (45802-059-11) / 30 g in 1 TUBE 45802-059-35 1 TUBE in 1 CARTON (45802-059-35) / 15 g in 1 TUBE

Ingredients (1)

nystatin (100000 [USP'U]/g)

Linked Drug Pages (1)

Nystatin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "e2839c50-5b8f-4e7b-9636-d22687038a89", "openfda": {"nui": ["N0000175498", "M0017172"], "unii": ["BDF1O1C72E"], "rxcui": ["543546"], "spl_set_id": ["e630aa3d-11a6-4300-942a-cbdf2d016f77"], "pharm_class_cs": ["Polyenes [CS]"], "pharm_class_epc": ["Polyene Antifungal [EPC]"], "manufacturer_name": ["Padagis Israel Pharmaceuticals Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (45802-059-11)  / 30 g in 1 TUBE", "package_ndc": "45802-059-11", "marketing_start_date": "20060921"}, {"sample": false, "description": "1 TUBE in 1 CARTON (45802-059-35)  / 15 g in 1 TUBE", "package_ndc": "45802-059-35", "marketing_start_date": "20070125"}], "brand_name": "Nystatin", "product_id": "45802-059_e2839c50-5b8f-4e7b-9636-d22687038a89", "dosage_form": "CREAM", "pharm_class": ["Polyene Antifungal [EPC]", "Polyenes [CS]"], "product_ndc": "45802-059", "generic_name": "Nystatin", "labeler_name": "Padagis Israel Pharmaceuticals Ltd", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nystatin", "active_ingredients": [{"name": "NYSTATIN", "strength": "100000 [USP'U]/g"}], "application_number": "ANDA062225", "marketing_category": "ANDA", "marketing_start_date": "20060921", "listing_expiration_date": "20261231"}