miconazole nitrate

Generic: miconazole nitrate

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name miconazole nitrate
Generic Name miconazole nitrate
Labeler sun pharmaceutical industries, inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

miconazole nitrate 20 mg/g

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 51672-2001
Product ID 51672-2001_39081fe5-0f4c-b99b-e063-6294a90a91a2
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M005
Listing Expiration 2026-12-31
Marketing Start 1991-10-01

Pharmacologic Class

Classes
azole antifungal [epc] azoles [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 516722001
Hyphenated Format 51672-2001

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

Resolved Composition

Strengths
  • 20 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (51672-2001-1) / 15 g in 1 TUBE
  • 1 TUBE in 1 CARTON (51672-2001-2) / 30 g in 1 TUBE
source: ndc

Packages (2)

51672-2001-1 1 TUBE in 1 CARTON (51672-2001-1) / 15 g in 1 TUBE 51672-2001-2 1 TUBE in 1 CARTON (51672-2001-2) / 30 g in 1 TUBE

Ingredients (1)

miconazole nitrate (20 mg/g)

Linked Drug Pages (1)

Miconazole Nitrate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "39081fe5-0f4c-b99b-e063-6294a90a91a2", "openfda": {"unii": ["VW4H1CYW1K"], "rxcui": ["998483"], "spl_set_id": ["7fd4037e-d350-47b7-a7d9-a43b8e366fa0"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (51672-2001-1)  / 15 g in 1 TUBE", "package_ndc": "51672-2001-1", "marketing_start_date": "19911001"}, {"sample": false, "description": "1 TUBE in 1 CARTON (51672-2001-2)  / 30 g in 1 TUBE", "package_ndc": "51672-2001-2", "marketing_start_date": "19911001"}], "brand_name": "Miconazole Nitrate", "product_id": "51672-2001_39081fe5-0f4c-b99b-e063-6294a90a91a2", "dosage_form": "CREAM", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "51672-2001", "generic_name": "Miconazole Nitrate", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Miconazole Nitrate", "active_ingredients": [{"name": "MICONAZOLE NITRATE", "strength": "20 mg/g"}], "application_number": "M005", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "19911001", "listing_expiration_date": "20261231"}