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 TINCTURE
Routes
TOPICAL
Active Ingredients

miconazole nitrate 20 mg/mL

Manufacturer
Stratus Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 58980-818
Product ID 58980-818_0892f504-c8a8-4aff-9901-223635b876c2
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M005
Listing Expiration 2026-12-31
Marketing Start 2017-09-15

Pharmacologic Class

Classes
azole antifungal [epc] azoles [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 58980818
Hyphenated Format 58980-818

Supplemental Identifiers

RxCUI
998525
UPC
0358980818109
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
  • 20 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, WITH APPLICATOR in 1 BOX (58980-818-10) / 29.57 mL in 1 BOTTLE, WITH APPLICATOR
source: ndc

Packages (1)

58980-818-10 1 BOTTLE, WITH APPLICATOR in 1 BOX (58980-818-10) / 29.57 mL in 1 BOTTLE, WITH APPLICATOR

Ingredients (1)

miconazole nitrate (20 mg/mL)

Linked Drug Pages (1)

Azolen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "0892f504-c8a8-4aff-9901-223635b876c2", "openfda": {"upc": ["0358980818109"], "unii": ["VW4H1CYW1K"], "rxcui": ["998525"], "spl_set_id": ["9c2574f3-3be4-405a-9c87-943dc6ef8777"], "manufacturer_name": ["Stratus Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, WITH APPLICATOR in 1 BOX (58980-818-10)  / 29.57 mL in 1 BOTTLE, WITH APPLICATOR", "package_ndc": "58980-818-10", "marketing_start_date": "20170915"}], "brand_name": "Azolen", "product_id": "58980-818_0892f504-c8a8-4aff-9901-223635b876c2", "dosage_form": "TINCTURE", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "58980-818", "generic_name": "Miconazole Nitrate", "labeler_name": "Stratus Pharmaceuticals, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Azolen", "active_ingredients": [{"name": "MICONAZOLE NITRATE", "strength": "20 mg/mL"}], "application_number": "M005", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20170915", "listing_expiration_date": "20261231"}