miconazole nitrate

Generic: anti-fungal powder miconazole nitrate talc free

Labeler: topco associates llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name miconazole nitrate
Generic Name anti-fungal powder miconazole nitrate talc free
Labeler topco associates llc
Dosage Form POWDER
Routes
TOPICAL
Active Ingredients

miconazole nitrate 1.42 g/71g

Manufacturer
Topco Associates LLC

Identifiers & Regulatory

Product NDC 36800-385
Product ID 36800-385_2655afa6-4595-89ba-e063-6394a90a22c5
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M005
Marketing Start 2017-12-07
Marketing End 2026-09-30

Pharmacologic Class

Classes
azole antifungal [epc] azoles [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 36800385
Hyphenated Format 36800-385

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 miconazole nitrate (source: ndc)
Generic Name anti-fungal powder miconazole nitrate talc free (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 (36800-385-25)
source: ndc

Packages (1)

36800-385-25 71 g in 1 BOTTLE, PLASTIC (36800-385-25)

Ingredients (1)

miconazole nitrate (1.42 g/71g)

Linked Drug Pages (1)

Miconazole Nitrate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "2655afa6-4595-89ba-e063-6394a90a22c5", "openfda": {"unii": ["VW4H1CYW1K"], "rxcui": ["998461"], "spl_set_id": ["0afaf920-e30a-4a7c-a19e-558b31ae7e58"], "manufacturer_name": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "71 g in 1 BOTTLE, PLASTIC (36800-385-25)", "package_ndc": "36800-385-25", "marketing_end_date": "20260930", "marketing_start_date": "20171207"}], "brand_name": "Miconazole Nitrate", "product_id": "36800-385_2655afa6-4595-89ba-e063-6394a90a22c5", "dosage_form": "POWDER", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "36800-385", "generic_name": "Anti-fungal Powder Miconazole Nitrate Talc Free", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Miconazole Nitrate", "active_ingredients": [{"name": "MICONAZOLE NITRATE", "strength": "1.42 g/71g"}], "application_number": "M005", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_end_date": "20260930", "marketing_start_date": "20171207"}