mycozyl ap

Generic: miconazole nitrate

Labeler: puretek corporation
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name mycozyl ap
Generic Name miconazole nitrate
Labeler puretek corporation
Dosage Form POWDER
Routes
TOPICAL
Active Ingredients

miconazole nitrate 2 g/85g

Manufacturer
PureTek Corporation

Identifiers & Regulatory

Product NDC 59088-442
Product ID 59088-442_237410ce-a7e8-47ec-e063-6394a90a89a2
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M005
Listing Expiration 2026-12-31
Marketing Start 2020-12-08

Pharmacologic Class

Classes
azole antifungal [epc] azoles [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59088442
Hyphenated Format 59088-442

Supplemental Identifiers

RxCUI
998461
UPC
0359088442074
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 mycozyl ap (source: ndc)
Generic Name miconazole nitrate (source: ndc)
Application Number M005 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 2 g/85g
source: ndc
Packaging
  • 85 g in 1 BOTTLE (59088-442-07)
source: ndc

Packages (1)

59088-442-07 85 g in 1 BOTTLE (59088-442-07)

Ingredients (1)

miconazole nitrate (2 g/85g)

Linked Drug Pages (1)

Mycozyl AP ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "237410ce-a7e8-47ec-e063-6394a90a89a2", "openfda": {"upc": ["0359088442074"], "unii": ["VW4H1CYW1K"], "rxcui": ["998461"], "spl_set_id": ["b3c46a30-7ff2-0dc4-e053-2995a90aa571"], "manufacturer_name": ["PureTek Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "85 g in 1 BOTTLE (59088-442-07)", "package_ndc": "59088-442-07", "marketing_start_date": "20201208"}], "brand_name": "Mycozyl AP", "product_id": "59088-442_237410ce-a7e8-47ec-e063-6394a90a89a2", "dosage_form": "POWDER", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "59088-442", "generic_name": "Miconazole Nitrate", "labeler_name": "PureTek Corporation", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Mycozyl AP", "active_ingredients": [{"name": "MICONAZOLE NITRATE", "strength": "2 g/85g"}], "application_number": "M005", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20201208", "listing_expiration_date": "20261231"}