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/mL

Manufacturer
Medline Industries, LP

Identifiers & Regulatory

Product NDC 53329-147
Product ID 53329-147_41edd027-d6ee-ca16-e063-6394a90a3d32
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M005
Listing Expiration 2026-12-31
Marketing Start 2023-08-01

Pharmacologic Class

Classes
azole antifungal [epc] azoles [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 53329147
Hyphenated Format 53329-147

Supplemental Identifiers

RxCUI
998483
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/mL
source: ndc
Packaging
  • 118 mL in 1 TUBE (53329-147-44)
source: ndc

Packages (1)

53329-147-44 118 mL in 1 TUBE (53329-147-44)

Ingredients (1)

miconazole nitrate (20 mg/mL)

Linked Drug Pages (1)

Medline ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "41edd027-d6ee-ca16-e063-6394a90a3d32", "openfda": {"unii": ["VW4H1CYW1K"], "rxcui": ["998483"], "spl_set_id": ["0d997d1d-8663-201f-e063-6394a90a285e"], "manufacturer_name": ["Medline Industries, LP"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 TUBE (53329-147-44)", "package_ndc": "53329-147-44", "marketing_start_date": "20230801"}], "brand_name": "Medline", "product_id": "53329-147_41edd027-d6ee-ca16-e063-6394a90a3d32", "dosage_form": "CREAM", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "53329-147", "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/mL"}], "application_number": "M005", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20230801", "listing_expiration_date": "20261231"}