miconazole nitrate 2% cream antifungal

Generic: miconazole nitrate

Labeler: astonea labs private limited
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name miconazole nitrate 2% cream antifungal
Generic Name miconazole nitrate
Labeler astonea labs private limited
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

miconazole nitrate 2 g/100g

Manufacturer
ASTONEA LABS PRIVATE LIMITED

Identifiers & Regulatory

Product NDC 77338-041
Product ID 77338-041_1bbb26c7-7122-8c78-e063-6394a90ae6a6
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M005
Listing Expiration 2026-12-31
Marketing Start 2016-03-22

Pharmacologic Class

Classes
azole antifungal [epc] azoles [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 77338041
Hyphenated Format 77338-041

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% cream antifungal (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
  • 113 g in 1 TUBE (77338-041-25)
source: ndc

Packages (1)

77338-041-25 113 g in 1 TUBE (77338-041-25)

Ingredients (1)

miconazole nitrate (2 g/100g)

Linked Drug Pages (1)

MICONAZOLE Nitrate 2% Cream ANTIFUNGAL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "1bbb26c7-7122-8c78-e063-6394a90ae6a6", "openfda": {"unii": ["VW4H1CYW1K"], "rxcui": ["998483"], "spl_set_id": ["e66191a6-0c3c-7319-e053-2a95a90aae84"], "manufacturer_name": ["ASTONEA LABS PRIVATE LIMITED"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "113 g in 1 TUBE (77338-041-25)", "package_ndc": "77338-041-25", "marketing_start_date": "20220816"}], "brand_name": "MICONAZOLE Nitrate 2% Cream ANTIFUNGAL", "product_id": "77338-041_1bbb26c7-7122-8c78-e063-6394a90ae6a6", "dosage_form": "CREAM", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "77338-041", "generic_name": "MICONAZOLE NITRATE", "labeler_name": "ASTONEA LABS PRIVATE LIMITED", "product_type": "HUMAN OTC DRUG", "brand_name_base": "MICONAZOLE Nitrate 2% Cream ANTIFUNGAL", "active_ingredients": [{"name": "MICONAZOLE NITRATE", "strength": "2 g/100g"}], "application_number": "M005", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20160322", "listing_expiration_date": "20261231"}