nystatin and triamcinolone acetonide (68071-5037)

Drug Facts

Product Profile

Brand Name nystatin and triamcinolone acetonide

Generic Name nystatin and triamcinolone acetonide

Labeler nucare pharmaceuticals,inc.

Dosage Form CREAM

Routes

TOPICAL

Active Ingredients

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

Manufacturer

NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-5037

Product ID 68071-5037_1b4117fd-e008-682d-e063-6394a90a89a8

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA062364

Listing Expiration 2026-12-31

Marketing Start 1987-12-22

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 680715037

Hyphenated Format 68071-5037

Supplemental Identifiers

RxCUI

1053753

UPC

0368071503739

UNII

BDF1O1C72E F446C597KA

NUI

N0000175498 M0017172 N0000175576 N0000175450

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 ANDA062364 (source: ndc)

Routes

TOPICAL

source: ndc

Resolved Composition

Strengths

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

source: ndc

Packaging

30 g in 1 TUBE (68071-5037-3)

source: ndc

Packages (1)

68071-5037-3 30 g in 1 TUBE (68071-5037-3)

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": "1b4117fd-e008-682d-e063-6394a90a89a8", "openfda": {"nui": ["N0000175498", "M0017172", "N0000175576", "N0000175450"], "upc": ["0368071503739"], "unii": ["BDF1O1C72E", "F446C597KA"], "rxcui": ["1053753"], "spl_set_id": ["90a58c0e-85cf-3aad-e053-2a95a90a316a"], "pharm_class_cs": ["Polyenes [CS]"], "pharm_class_epc": ["Polyene Antifungal [EPC]", "Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 g in 1 TUBE (68071-5037-3)", "package_ndc": "68071-5037-3", "marketing_start_date": "20190821"}], "brand_name": "Nystatin and Triamcinolone Acetonide", "product_id": "68071-5037_1b4117fd-e008-682d-e063-6394a90a89a8", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]", "Polyene Antifungal [EPC]", "Polyenes [CS]"], "product_ndc": "68071-5037", "generic_name": "Nystatin and Triamcinolone Acetonide", "labeler_name": "NuCare 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": "ANDA062364", "marketing_category": "ANDA", "marketing_start_date": "19871222", "listing_expiration_date": "20261231"}