miconazole nitrate 2% cream antifungal

Generic: miconazole nitrate

Labeler: trifecta pharmaceuticals usa llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name miconazole nitrate 2% cream antifungal
Generic Name miconazole nitrate
Labeler trifecta pharmaceuticals usa llc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

miconazole nitrate 2 g/100g

Manufacturer
Trifecta Pharmaceuticals Usa Llc

Identifiers & Regulatory

Product NDC 69396-014
Product ID 69396-014_2d6792ee-43e9-f011-e063-6394a90accd1
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M005
Listing Expiration 2026-12-31
Marketing Start 2016-03-22

Pharmacologic Class

Classes
azole antifungal [epc] azoles [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69396014
Hyphenated Format 69396-014

Supplemental Identifiers

RxCUI
998483
UNII
VW4H1CYW1K

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 miconazole nitrate 2% cream antifungal (source: ndc)
Generic Name miconazole nitrate (source: ndc)
Application Number M005 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 2 g/100g
source: ndc
Packaging
  • 118.3 g in 1 TUBE (69396-014-04)
  • 15 g in 1 TUBE (69396-014-05)
  • 1 TUBE in 1 BOX (69396-014-20) / 30 g in 1 TUBE
  • 3 TUBE in 1 BOX (69396-014-33) / 30 g in 1 TUBE
  • 4 TUBE in 1 BOX (69396-014-44) / 30 g in 1 TUBE
  • 6 TUBE in 1 BOX (69396-014-66) / 30 g in 1 TUBE
source: ndc

Packages (6)

69396-014-04 118.3 g in 1 TUBE (69396-014-04) 69396-014-05 15 g in 1 TUBE (69396-014-05) 69396-014-20 1 TUBE in 1 BOX (69396-014-20) / 30 g in 1 TUBE 69396-014-33 3 TUBE in 1 BOX (69396-014-33) / 30 g in 1 TUBE 69396-014-44 4 TUBE in 1 BOX (69396-014-44) / 30 g in 1 TUBE 69396-014-66 6 TUBE in 1 BOX (69396-014-66) / 30 g in 1 TUBE

Ingredients (1)

miconazole nitrate (2 g/100g)

Linked Drug Pages (1)

MICONAZOLE Nitrate 2% Cream ANTIFUNGAL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "2d6792ee-43e9-f011-e063-6394a90accd1", "openfda": {"unii": ["VW4H1CYW1K"], "rxcui": ["998483"], "spl_set_id": ["80217dbb-a0f0-414a-8d22-a9a346b017aa"], "manufacturer_name": ["Trifecta Pharmaceuticals Usa Llc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "118.3 g in 1 TUBE (69396-014-04)", "package_ndc": "69396-014-04", "marketing_start_date": "20220923"}, {"sample": false, "description": "15 g in 1 TUBE (69396-014-05)", "package_ndc": "69396-014-05", "marketing_start_date": "20160322"}, {"sample": false, "description": "1 TUBE in 1 BOX (69396-014-20)  / 30 g in 1 TUBE", "package_ndc": "69396-014-20", "marketing_start_date": "20160322"}, {"sample": false, "description": "3 TUBE in 1 BOX (69396-014-33)  / 30 g in 1 TUBE", "package_ndc": "69396-014-33", "marketing_start_date": "20240322"}, {"sample": false, "description": "4 TUBE in 1 BOX (69396-014-44)  / 30 g in 1 TUBE", "package_ndc": "69396-014-44", "marketing_start_date": "20240229"}, {"sample": false, "description": "6 TUBE in 1 BOX (69396-014-66)  / 30 g in 1 TUBE", "package_ndc": "69396-014-66", "marketing_start_date": "20240222"}], "brand_name": "MICONAZOLE Nitrate 2% Cream ANTIFUNGAL", "product_id": "69396-014_2d6792ee-43e9-f011-e063-6394a90accd1", "dosage_form": "CREAM", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "69396-014", "generic_name": "MICONAZOLE NITRATE", "labeler_name": "Trifecta Pharmaceuticals Usa Llc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "MICONAZOLE Nitrate 2% Cream ANTIFUNGAL", "active_ingredients": [{"name": "MICONAZOLE NITRATE", "strength": "2 g/100g"}], "application_number": "M005", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20160322", "listing_expiration_date": "20261231"}