miconazole nitrate

Generic: miconazole nitrate

Labeler: avpak
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name miconazole nitrate
Generic Name miconazole nitrate
Labeler avpak
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

miconazole nitrate 20 mg/mL

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-503
Product ID 50268-503_47fa5320-5565-5626-e063-6394a90a4396
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M005
Listing Expiration 2027-12-31
Marketing Start 2022-10-13

Pharmacologic Class

Classes
azole antifungal [epc] azoles [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50268503
Hyphenated Format 50268-503

Supplemental Identifiers

RxCUI
998525
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 (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
  • 29.57 mL in 1 BOTTLE (50268-503-29)
source: ndc

Packages (1)

50268-503-29 29.57 mL in 1 BOTTLE (50268-503-29)

Ingredients (1)

miconazole nitrate (20 mg/mL)

Linked Drug Pages (1)

miconazole nitrate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "47fa5320-5565-5626-e063-6394a90a4396", "openfda": {"unii": ["VW4H1CYW1K"], "rxcui": ["998525"], "spl_set_id": ["eaf016f6-b631-af00-e053-2a95a90adc7b"], "manufacturer_name": ["AvPAK"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "29.57 mL in 1 BOTTLE (50268-503-29)", "package_ndc": "50268-503-29", "marketing_start_date": "20221013"}], "brand_name": "miconazole nitrate", "product_id": "50268-503_47fa5320-5565-5626-e063-6394a90a4396", "dosage_form": "SOLUTION", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "50268-503", "generic_name": "Miconazole Nitrate", "labeler_name": "AvPAK", "product_type": "HUMAN OTC DRUG", "brand_name_base": "miconazole nitrate", "active_ingredients": [{"name": "MICONAZOLE NITRATE", "strength": "20 mg/mL"}], "application_number": "M005", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20221013", "listing_expiration_date": "20271231"}