medline

Generic: miconazole nitrate

Labeler: medline industries, lp
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name medline
Generic Name miconazole nitrate
Labeler medline industries, lp
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

miconazole nitrate 20 mg/100g

Manufacturer
Medline Industries, LP

Identifiers & Regulatory

Product NDC 53329-218
Product ID 53329-218_42f3af59-a020-421e-e063-6294a90a6eab
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M005
Listing Expiration 2026-12-31
Marketing Start 2024-10-01

Pharmacologic Class

Classes
azole antifungal [epc] azoles [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 53329218
Hyphenated Format 53329-218

Supplemental Identifiers

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

Resolved Composition

Strengths
  • 20 mg/100g
source: ndc
Packaging
  • 113 g in 1 TUBE (53329-218-44)
source: ndc

Packages (1)

53329-218-44 113 g in 1 TUBE (53329-218-44)

Ingredients (1)

miconazole nitrate (20 mg/100g)

Linked Drug Pages (1)

Medline ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "42f3af59-a020-421e-e063-6294a90a6eab", "openfda": {"unii": ["VW4H1CYW1K"], "spl_set_id": ["1ea444eb-f2f5-8c63-e063-6294a90acac8"], "manufacturer_name": ["Medline Industries, LP"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "113 g in 1 TUBE (53329-218-44)", "package_ndc": "53329-218-44", "marketing_start_date": "20241001"}], "brand_name": "Medline", "product_id": "53329-218_42f3af59-a020-421e-e063-6294a90a6eab", "dosage_form": "CREAM", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "53329-218", "generic_name": "Miconazole nitrate", "labeler_name": "Medline Industries, LP", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Medline", "active_ingredients": [{"name": "MICONAZOLE NITRATE", "strength": "20 mg/100g"}], "application_number": "M005", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20241001", "listing_expiration_date": "20261231"}