azolen

Generic: miconazole nitrate

Labeler: stratus pharmaceuticals inc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name azolen
Generic Name miconazole nitrate
Labeler stratus pharmaceuticals inc
Dosage Form LIQUID
Routes
TOPICAL
Active Ingredients

miconazole nitrate 2 mg/g

Manufacturer
STRATUS PHARMACEUTICALS INC

Identifiers & Regulatory

Product NDC 58980-819
Product ID 58980-819_85b974c1-bef2-4320-93a4-0fcf7774c55c
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M005
Listing Expiration 2026-12-31
Marketing Start 2023-09-14

Pharmacologic Class

Classes
azole antifungal [epc] azoles [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 58980819
Hyphenated Format 58980-819

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

Resolved Composition

Strengths
  • 2 mg/g
source: ndc
Packaging
  • 1 BOTTLE in 1 BOX (58980-819-60) / 170 g in 1 BOTTLE
source: ndc

Packages (1)

58980-819-60 1 BOTTLE in 1 BOX (58980-819-60) / 170 g in 1 BOTTLE

Ingredients (1)

miconazole nitrate (2 mg/g)

Linked Drug Pages (1)

AZOLEN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "85b974c1-bef2-4320-93a4-0fcf7774c55c", "openfda": {"unii": ["VW4H1CYW1K"], "spl_set_id": ["3264bd0a-c628-404b-8c09-8586682d054e"], "manufacturer_name": ["STRATUS PHARMACEUTICALS INC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 BOX (58980-819-60)  / 170 g in 1 BOTTLE", "package_ndc": "58980-819-60", "marketing_start_date": "20230914"}], "brand_name": "AZOLEN", "product_id": "58980-819_85b974c1-bef2-4320-93a4-0fcf7774c55c", "dosage_form": "LIQUID", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "58980-819", "generic_name": "MICONAZOLE NITRATE", "labeler_name": "STRATUS PHARMACEUTICALS INC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "AZOLEN", "active_ingredients": [{"name": "MICONAZOLE NITRATE", "strength": "2 mg/g"}], "application_number": "M005", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20230914", "listing_expiration_date": "20261231"}