anti-fungal powder miconazole nitrate

Generic: miconazole nitrate

Labeler: premier brands of america inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name anti-fungal powder miconazole nitrate
Generic Name miconazole nitrate
Labeler premier brands of america inc.
Dosage Form POWDER
Routes
TOPICAL
Active Ingredients

miconazole nitrate 20 mg/g

Manufacturer
Premier Brands of America Inc.

Identifiers & Regulatory

Product NDC 56104-500
Product ID 56104-500_42537026-f1f3-422f-e063-6394a90a07e9
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M005
Listing Expiration 2026-12-31
Marketing Start 2023-09-12

Pharmacologic Class

Classes
azole antifungal [epc] azoles [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 56104500
Hyphenated Format 56104-500

Supplemental Identifiers

RxCUI
998461
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 anti-fungal powder miconazole nitrate (source: ndc)
Generic Name miconazole nitrate (source: ndc)
Application Number M005 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/g
source: ndc
Packaging
  • 71 g in 1 BOTTLE, PLASTIC (56104-500-00)
source: ndc

Packages (1)

56104-500-00 71 g in 1 BOTTLE, PLASTIC (56104-500-00)

Ingredients (1)

miconazole nitrate (20 mg/g)

Linked Drug Pages (1)

Anti-fungal Powder Miconazole Nitrate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "42537026-f1f3-422f-e063-6394a90a07e9", "openfda": {"unii": ["VW4H1CYW1K"], "rxcui": ["998461"], "spl_set_id": ["052d8d02-2381-1e3a-e063-6394a90aa07e"], "manufacturer_name": ["Premier Brands of America Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "71 g in 1 BOTTLE, PLASTIC (56104-500-00)", "package_ndc": "56104-500-00", "marketing_start_date": "20230912"}], "brand_name": "Anti-fungal Powder Miconazole Nitrate", "product_id": "56104-500_42537026-f1f3-422f-e063-6394a90a07e9", "dosage_form": "POWDER", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "56104-500", "generic_name": "Miconazole Nitrate", "labeler_name": "Premier Brands of America Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Anti-fungal Powder Miconazole Nitrate", "active_ingredients": [{"name": "MICONAZOLE NITRATE", "strength": "20 mg/g"}], "application_number": "M005", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20230912", "listing_expiration_date": "20261231"}