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

miconazole nitrate 1.42 g/71g

Manufacturer
Premier Brands of America Inc.

Identifiers & Regulatory

Product NDC 56104-253
Product ID 56104-253_3bba5b9f-d184-6f93-e063-6394a90ae951
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M005
Marketing Start 2022-04-11
Marketing End 2027-01-31

Pharmacologic Class

Classes
azole antifungal [epc] azoles [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 56104253
Hyphenated Format 56104-253

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 miconazole nitrate (source: ndc)
Generic Name miconazole nitrate (source: ndc)
Application Number M005 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1.42 g/71g
source: ndc
Packaging
  • 71 g in 1 BOTTLE, PLASTIC (56104-253-01)
source: ndc

Packages (1)

56104-253-01 71 g in 1 BOTTLE, PLASTIC (56104-253-01)

Ingredients (1)

miconazole nitrate (1.42 g/71g)

Linked Drug Pages (1)

Anti- Fungal Miconazole Nitrate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "3bba5b9f-d184-6f93-e063-6394a90ae951", "openfda": {"unii": ["VW4H1CYW1K"], "rxcui": ["998461"], "spl_set_id": ["f186bdc1-db6c-0fab-e053-2995a90a7c58"], "manufacturer_name": ["Premier Brands of America Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "71 g in 1 BOTTLE, PLASTIC (56104-253-01)", "package_ndc": "56104-253-01", "marketing_end_date": "20270131", "marketing_start_date": "20230105"}], "brand_name": "Anti- Fungal Miconazole Nitrate", "product_id": "56104-253_3bba5b9f-d184-6f93-e063-6394a90ae951", "dosage_form": "POWDER", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "56104-253", "generic_name": "Miconazole Nitrate", "labeler_name": "Premier Brands of America Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Anti- Fungal Miconazole Nitrate", "active_ingredients": [{"name": "MICONAZOLE NITRATE", "strength": "1.42 g/71g"}], "application_number": "M005", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_end_date": "20270131", "marketing_start_date": "20220411"}