miconazole nitrate 2%

Generic: miconazole nitrate

Labeler: akron pharma inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name miconazole nitrate 2%
Generic Name miconazole nitrate
Labeler akron pharma inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

miconazole nitrate 2 g/100g

Manufacturer
Akron Pharma Inc.

Identifiers & Regulatory

Product NDC 71399-0071
Product ID 71399-0071_b1ef7656-ad4c-4c56-987a-18628f9d9dca
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M005
Listing Expiration 2026-12-31
Marketing Start 2024-11-19

Pharmacologic Class

Classes
azole antifungal [epc] azoles [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 713990071
Hyphenated Format 71399-0071

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 miconazole nitrate 2% (source: ndc)
Generic Name miconazole nitrate (source: ndc)
Application Number M005 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 2 g/100g
source: ndc
Packaging
  • 1 TUBE in 1 BOX (71399-0071-1) / 14.2 g in 1 TUBE
  • 1 TUBE in 1 BOX (71399-0071-3) / 28.4 g in 1 TUBE
  • 1 TUBE in 1 BOX (71399-0071-4) / 42.5 g in 1 TUBE
source: ndc

Packages (3)

71399-0071-1 1 TUBE in 1 BOX (71399-0071-1) / 14.2 g in 1 TUBE 71399-0071-3 1 TUBE in 1 BOX (71399-0071-3) / 28.4 g in 1 TUBE 71399-0071-4 1 TUBE in 1 BOX (71399-0071-4) / 42.5 g in 1 TUBE

Ingredients (1)

miconazole nitrate (2 g/100g)

Linked Drug Pages (1)

MICONAZOLE Nitrate 2% ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "b1ef7656-ad4c-4c56-987a-18628f9d9dca", "openfda": {"unii": ["VW4H1CYW1K"], "rxcui": ["998483"], "spl_set_id": ["8933f939-098a-4257-8d9c-4d5c3240e9a6"], "manufacturer_name": ["Akron Pharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 BOX (71399-0071-1)  / 14.2 g in 1 TUBE", "package_ndc": "71399-0071-1", "marketing_start_date": "20241119"}, {"sample": false, "description": "1 TUBE in 1 BOX (71399-0071-3)  / 28.4 g in 1 TUBE", "package_ndc": "71399-0071-3", "marketing_start_date": "20241119"}, {"sample": false, "description": "1 TUBE in 1 BOX (71399-0071-4)  / 42.5 g in 1 TUBE", "package_ndc": "71399-0071-4", "marketing_start_date": "20241119"}], "brand_name": "MICONAZOLE Nitrate 2%", "product_id": "71399-0071_b1ef7656-ad4c-4c56-987a-18628f9d9dca", "dosage_form": "CREAM", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "71399-0071", "generic_name": "MICONAZOLE NITRATE", "labeler_name": "Akron Pharma Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "MICONAZOLE Nitrate 2%", "active_ingredients": [{"name": "MICONAZOLE NITRATE", "strength": "2 g/100g"}], "application_number": "M005", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20241119", "listing_expiration_date": "20261231"}