antifungal

Generic: miconazole nitrate

Labeler: advanced rx llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name antifungal
Generic Name miconazole nitrate
Labeler advanced rx llc
Dosage Form POWDER
Routes
TOPICAL
Active Ingredients

miconazole nitrate 20 mg/g

Manufacturer
Advanced Rx LLC

Identifiers & Regulatory

Product NDC 80513-771
Product ID 80513-771_3af71de6-43f9-b1a2-e063-6394a90a5050
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M005
Listing Expiration 2026-12-31
Marketing Start 2025-01-01

Pharmacologic Class

Classes
azole antifungal [epc] azoles [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 80513771
Hyphenated Format 80513-771

Supplemental Identifiers

RxCUI
998461
UPC
0380513000392
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 antifungal (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
  • 85 g in 1 BOTTLE (80513-771-03)
source: ndc

Packages (1)

80513-771-03 85 g in 1 BOTTLE (80513-771-03)

Ingredients (1)

miconazole nitrate (20 mg/g)

Linked Drug Pages (1)

Antifungal ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "3af71de6-43f9-b1a2-e063-6394a90a5050", "openfda": {"upc": ["0380513000392"], "unii": ["VW4H1CYW1K"], "rxcui": ["998461"], "spl_set_id": ["e13eb653-3916-444a-ae86-1738c0308b79"], "manufacturer_name": ["Advanced Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "85 g in 1 BOTTLE (80513-771-03)", "package_ndc": "80513-771-03", "marketing_start_date": "20250101"}], "brand_name": "Antifungal", "product_id": "80513-771_3af71de6-43f9-b1a2-e063-6394a90a5050", "dosage_form": "POWDER", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "80513-771", "generic_name": "Miconazole Nitrate", "labeler_name": "Advanced Rx LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Antifungal", "active_ingredients": [{"name": "MICONAZOLE NITRATE", "strength": "20 mg/g"}], "application_number": "M005", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250101", "listing_expiration_date": "20261231"}