nystatin

Generic: nystatin

Labeler: viona pharmaceuticals inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nystatin
Generic Name nystatin
Labeler viona pharmaceuticals inc
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

nystatin 100000 U/g

Manufacturer
Viona Pharmaceuticals Inc

Identifiers & Regulatory

Product NDC 72578-089
Product ID 72578-089_3d917a6c-4e9a-4c45-9e79-caf91f8b11b0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207767
Listing Expiration 2026-12-31
Marketing Start 2020-06-24

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72578089
Hyphenated Format 72578-089

Supplemental Identifiers

RxCUI
884308
UPC
0372578089016
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 ANDA207767 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 100000 U/g
source: ndc
Packaging
  • 15 g in 1 TUBE (72578-089-01)
  • 30 g in 1 TUBE (72578-089-04)
source: ndc

Packages (2)

72578-089-01 15 g in 1 TUBE (72578-089-01) 72578-089-04 30 g in 1 TUBE (72578-089-04)

Ingredients (1)

nystatin (100000 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": "3d917a6c-4e9a-4c45-9e79-caf91f8b11b0", "openfda": {"nui": ["N0000175498", "M0017172"], "upc": ["0372578089016"], "unii": ["BDF1O1C72E"], "rxcui": ["884308"], "spl_set_id": ["e135a7d2-adba-48a2-b3e1-07b778cce9b0"], "pharm_class_cs": ["Polyenes [CS]"], "pharm_class_epc": ["Polyene Antifungal [EPC]"], "manufacturer_name": ["Viona Pharmaceuticals Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "15 g in 1 TUBE (72578-089-01)", "package_ndc": "72578-089-01", "marketing_start_date": "20200624"}, {"sample": false, "description": "30 g in 1 TUBE (72578-089-04)", "package_ndc": "72578-089-04", "marketing_start_date": "20200624"}], "brand_name": "Nystatin", "product_id": "72578-089_3d917a6c-4e9a-4c45-9e79-caf91f8b11b0", "dosage_form": "OINTMENT", "pharm_class": ["Polyene Antifungal [EPC]", "Polyenes [CS]"], "product_ndc": "72578-089", "generic_name": "Nystatin", "labeler_name": "Viona Pharmaceuticals Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nystatin", "active_ingredients": [{"name": "NYSTATIN", "strength": "100000 U/g"}], "application_number": "ANDA207767", "marketing_category": "ANDA", "marketing_start_date": "20200624", "listing_expiration_date": "20261231"}