nystatin and triamcinolone acetonide (0316-0223)

Drug Facts

Product Profile

Brand Name nystatin and triamcinolone acetonide

Generic Name nystatin and triamcinolone acetonide

Labeler crown laboratories

Dosage Form CREAM

Routes

TOPICAL

Active Ingredients

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

Manufacturer

Crown Laboratories

Identifiers & Regulatory

Product NDC 0316-0223

Product ID 0316-0223_483437cb-feeb-0aa8-e063-6294a90a5c4f

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA207730

Listing Expiration 2027-12-31

Marketing Start 2018-01-02

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 03160223

Hyphenated Format 0316-0223

Supplemental Identifiers

RxCUI

1053753

UPC

0303160223303

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 ANDA207730 (source: ndc)

Routes

TOPICAL

source: ndc

Resolved Composition

Strengths

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

source: ndc

Packaging

1 TUBE in 1 CARTON (0316-0223-15) / 15 g in 1 TUBE
1 TUBE in 1 CARTON (0316-0223-30) / 30 g in 1 TUBE
1 TUBE in 1 CARTON (0316-0223-60) / 60 g in 1 TUBE

source: ndc

Packages (3)

0316-0223-15 1 TUBE in 1 CARTON (0316-0223-15) / 15 g in 1 TUBE 0316-0223-30 1 TUBE in 1 CARTON (0316-0223-30) / 30 g in 1 TUBE 0316-0223-60 1 TUBE in 1 CARTON (0316-0223-60) / 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": "483437cb-feeb-0aa8-e063-6294a90a5c4f", "openfda": {"nui": ["N0000175498", "M0017172", "N0000175576", "N0000175450"], "upc": ["0303160223303"], "unii": ["BDF1O1C72E", "F446C597KA"], "rxcui": ["1053753"], "spl_set_id": ["54aae5d3-e482-4da0-a1b2-0ed70e6c2915"], "pharm_class_cs": ["Polyenes [CS]"], "pharm_class_epc": ["Polyene Antifungal [EPC]", "Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Crown Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (0316-0223-15)  / 15 g in 1 TUBE", "package_ndc": "0316-0223-15", "marketing_start_date": "20180102"}, {"sample": false, "description": "1 TUBE in 1 CARTON (0316-0223-30)  / 30 g in 1 TUBE", "package_ndc": "0316-0223-30", "marketing_start_date": "20180102"}, {"sample": false, "description": "1 TUBE in 1 CARTON (0316-0223-60)  / 60 g in 1 TUBE", "package_ndc": "0316-0223-60", "marketing_start_date": "20180102"}], "brand_name": "Nystatin and Triamcinolone Acetonide", "product_id": "0316-0223_483437cb-feeb-0aa8-e063-6294a90a5c4f", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]", "Polyene Antifungal [EPC]", "Polyenes [CS]"], "product_ndc": "0316-0223", "generic_name": "Nystatin and Triamcinolone Acetonide", "labeler_name": "Crown Laboratories", "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": "ANDA207730", "marketing_category": "ANDA", "marketing_start_date": "20180102", "listing_expiration_date": "20271231"}