nystatin and triamcinolone acetonide (21922-031)

Drug Facts

Product Profile

Brand Name nystatin and triamcinolone acetonide

Generic Name nystatin and triamcinolone acetonide

Labeler encube ethicals, inc.

Dosage Form OINTMENT

Routes

TOPICAL

Active Ingredients

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

Manufacturer

Encube Ethicals, Inc.

Identifiers & Regulatory

Product NDC 21922-031

Product ID 21922-031_b18e996f-bdb8-4028-9862-fbab75aebf69

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA207741

Listing Expiration 2026-12-31

Marketing Start 2019-09-28

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 21922031

Hyphenated Format 21922-031

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 ANDA207741 (source: ndc)

Routes

TOPICAL

source: ndc

Resolved Composition

Strengths

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

source: ndc

Packaging

1 TUBE in 1 CARTON (21922-031-04) / 15 g in 1 TUBE
1 TUBE in 1 CARTON (21922-031-05) / 30 g in 1 TUBE
1 TUBE in 1 CARTON (21922-031-07) / 60 g in 1 TUBE

source: ndc

Packages (3)

21922-031-04 1 TUBE in 1 CARTON (21922-031-04) / 15 g in 1 TUBE 21922-031-05 1 TUBE in 1 CARTON (21922-031-05) / 30 g in 1 TUBE 21922-031-07 1 TUBE in 1 CARTON (21922-031-07) / 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": "b18e996f-bdb8-4028-9862-fbab75aebf69", "openfda": {"nui": ["N0000175498", "M0017172", "N0000175576", "N0000175450"], "unii": ["BDF1O1C72E", "F446C597KA"], "rxcui": ["1053697"], "spl_set_id": ["d33829fc-86df-4e28-82c3-9dbcd8a9e28d"], "pharm_class_cs": ["Polyenes [CS]"], "pharm_class_epc": ["Polyene Antifungal [EPC]", "Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Encube Ethicals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (21922-031-04)  / 15 g in 1 TUBE", "package_ndc": "21922-031-04", "marketing_start_date": "20190928"}, {"sample": false, "description": "1 TUBE in 1 CARTON (21922-031-05)  / 30 g in 1 TUBE", "package_ndc": "21922-031-05", "marketing_start_date": "20190928"}, {"sample": false, "description": "1 TUBE in 1 CARTON (21922-031-07)  / 60 g in 1 TUBE", "package_ndc": "21922-031-07", "marketing_start_date": "20190928"}], "brand_name": "Nystatin and Triamcinolone Acetonide", "product_id": "21922-031_b18e996f-bdb8-4028-9862-fbab75aebf69", "dosage_form": "OINTMENT", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]", "Polyene Antifungal [EPC]", "Polyenes [CS]"], "product_ndc": "21922-031", "generic_name": "Nystatin and Triamcinolone Acetonide", "labeler_name": "Encube Ethicals, 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": "ANDA207741", "marketing_category": "ANDA", "marketing_start_date": "20190928", "listing_expiration_date": "20261231"}