nystatin and triamcinolone acetonide (45802-244)

Drug Facts

Product Profile

Brand Name nystatin and triamcinolone acetonide

Generic Name nystatin and triamcinolone acetonide

Labeler padagis israel pharmaceuticals ltd

Dosage Form OINTMENT

Routes

TOPICAL

Active Ingredients

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

Manufacturer

Padagis Israel Pharmaceuticals Ltd

Identifiers & Regulatory

Product NDC 45802-244

Product ID 45802-244_5797c2ea-37cd-4a6f-87ce-030df00cb949

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA207380

Listing Expiration 2026-12-31

Marketing Start 2017-10-18

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 45802244

Hyphenated Format 45802-244

Supplemental Identifiers

RxCUI

1053697

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 ANDA207380 (source: ndc)

Routes

TOPICAL

source: ndc

Resolved Composition

Strengths

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

source: ndc

Packaging

1 TUBE in 1 CARTON (45802-244-14) / 15 g in 1 TUBE
1 TUBE in 1 CARTON (45802-244-94) / 30 g in 1 TUBE
1 TUBE in 1 CARTON (45802-244-96) / 60 g in 1 TUBE

source: ndc

Packages (3)

45802-244-14 1 TUBE in 1 CARTON (45802-244-14) / 15 g in 1 TUBE 45802-244-94 1 TUBE in 1 CARTON (45802-244-94) / 30 g in 1 TUBE 45802-244-96 1 TUBE in 1 CARTON (45802-244-96) / 60 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": "5797c2ea-37cd-4a6f-87ce-030df00cb949", "openfda": {"nui": ["N0000175498", "M0017172", "N0000175576", "N0000175450"], "unii": ["BDF1O1C72E", "F446C597KA"], "rxcui": ["1053697"], "spl_set_id": ["605540d8-7189-49b9-9e91-572f6b519fae"], "pharm_class_cs": ["Polyenes [CS]"], "pharm_class_epc": ["Polyene Antifungal [EPC]", "Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Padagis Israel Pharmaceuticals Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (45802-244-14)  / 15 g in 1 TUBE", "package_ndc": "45802-244-14", "marketing_start_date": "20171018"}, {"sample": false, "description": "1 TUBE in 1 CARTON (45802-244-94)  / 30 g in 1 TUBE", "package_ndc": "45802-244-94", "marketing_start_date": "20171018"}, {"sample": false, "description": "1 TUBE in 1 CARTON (45802-244-96)  / 60 g in 1 TUBE", "package_ndc": "45802-244-96", "marketing_start_date": "20171018"}], "brand_name": "nystatin and triamcinolone acetonide", "product_id": "45802-244_5797c2ea-37cd-4a6f-87ce-030df00cb949", "dosage_form": "OINTMENT", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]", "Polyene Antifungal [EPC]", "Polyenes [CS]"], "product_ndc": "45802-244", "generic_name": "nystatin and triamcinolone acetonide", "labeler_name": "Padagis Israel Pharmaceuticals Ltd", "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": "ANDA207380", "marketing_category": "ANDA", "marketing_start_date": "20171018", "listing_expiration_date": "20261231"}