nystatin and triamcinolone acetonide (72578-088)

Drug Facts

Product Profile

Brand Name nystatin and triamcinolone acetonide

Generic Name nystatin and triamcinolone acetonide

Labeler viona pharmaceuticals inc

Dosage Form OINTMENT

Routes

TOPICAL

Active Ingredients

nystatin 100000 [USP'U]/g, triamcinolone acetonide 1 mg/g

Manufacturer

Viona Pharmaceuticals Inc

Identifiers & Regulatory

Product NDC 72578-088

Product ID 72578-088_1a3aab5b-5427-414c-a40f-ed4ea70da502

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA207764

Listing Expiration 2026-12-31

Marketing Start 2020-06-24

Pharmacologic Class

Established (EPC)

polyene antifungal [epc] corticosteroid [epc]

Mechanism of Action

corticosteroid hormone receptor agonists [moa]

Chemical Structure

polyenes [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72578088

Hyphenated Format 72578-088

Supplemental Identifiers

RxCUI

1053697

UPC

0372578088019

UNII

BDF1O1C72E F446C597KA

NUI

N0000175498 M0017172 N0000175576 N0000175450

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 and triamcinolone acetonide (source: ndc)

Generic Name nystatin and triamcinolone acetonide (source: ndc)

Application Number ANDA207764 (source: ndc)

Routes

TOPICAL

source: ndc

Resolved Composition

Strengths

100000 [USP'U]/g
1 mg/g

source: ndc

Packaging

1 TUBE in 1 CARTON (72578-088-01) / 15 g in 1 TUBE
1 TUBE in 1 CARTON (72578-088-02) / 60 g in 1 TUBE
1 TUBE in 1 CARTON (72578-088-04) / 30 g in 1 TUBE

source: ndc

Packages (3)

72578-088-01 1 TUBE in 1 CARTON (72578-088-01) / 15 g in 1 TUBE 72578-088-02 1 TUBE in 1 CARTON (72578-088-02) / 60 g in 1 TUBE 72578-088-04 1 TUBE in 1 CARTON (72578-088-04) / 30 g in 1 TUBE

Ingredients (2)

nystatin (100000 [USP'U]/g) triamcinolone acetonide (1 mg/g)

Linked Drug Pages (1)

Nystatin and Triamcinolone Acetonide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["TOPICAL"], "spl_id": "1a3aab5b-5427-414c-a40f-ed4ea70da502", "openfda": {"nui": ["N0000175498", "M0017172", "N0000175576", "N0000175450"], "upc": ["0372578088019"], "unii": ["BDF1O1C72E", "F446C597KA"], "rxcui": ["1053697"], "spl_set_id": ["d3799da3-5923-4225-9c61-2b5af143f555"], "pharm_class_cs": ["Polyenes [CS]"], "pharm_class_epc": ["Polyene Antifungal [EPC]", "Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Viona Pharmaceuticals Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (72578-088-01)  / 15 g in 1 TUBE", "package_ndc": "72578-088-01", "marketing_start_date": "20200624"}, {"sample": false, "description": "1 TUBE in 1 CARTON (72578-088-02)  / 60 g in 1 TUBE", "package_ndc": "72578-088-02", "marketing_start_date": "20200624"}, {"sample": false, "description": "1 TUBE in 1 CARTON (72578-088-04)  / 30 g in 1 TUBE", "package_ndc": "72578-088-04", "marketing_start_date": "20200624"}], "brand_name": "Nystatin and Triamcinolone Acetonide", "product_id": "72578-088_1a3aab5b-5427-414c-a40f-ed4ea70da502", "dosage_form": "OINTMENT", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]", "Polyene Antifungal [EPC]", "Polyenes [CS]"], "product_ndc": "72578-088", "generic_name": "Nystatin and Triamcinolone Acetonide", "labeler_name": "Viona Pharmaceuticals Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nystatin and Triamcinolone Acetonide", "active_ingredients": [{"name": "NYSTATIN", "strength": "100000 [USP'U]/g"}, {"name": "TRIAMCINOLONE ACETONIDE", "strength": "1 mg/g"}], "application_number": "ANDA207764", "marketing_category": "ANDA", "marketing_start_date": "20200624", "listing_expiration_date": "20261231"}