miconazole

Generic: miconazole nitrate

Labeler: chain drug consortium, llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name miconazole
Generic Name miconazole nitrate
Labeler chain drug consortium, llc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

miconazole nitrate 20 mg/g

Manufacturer
Chain Drug Consortium, LLC

Identifiers & Regulatory

Product NDC 68016-291
Product ID 68016-291_421e11c4-085b-4f3d-bbbc-079d4ea522fc
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M005
Marketing Start 2009-05-15
Marketing End 2026-12-31

Pharmacologic Class

Classes
azole antifungal [epc] azoles [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68016291
Hyphenated Format 68016-291

Supplemental Identifiers

RxCUI
998483
UPC
0840986021794
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 (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 (68016-291-01) / 28 g in 1 TUBE
source: ndc

Packages (1)

68016-291-01 1 TUBE in 1 CARTON (68016-291-01) / 28 g in 1 TUBE

Ingredients (1)

miconazole nitrate (20 mg/g)

Linked Drug Pages (1)

Miconazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "421e11c4-085b-4f3d-bbbc-079d4ea522fc", "openfda": {"upc": ["0840986021794"], "unii": ["VW4H1CYW1K"], "rxcui": ["998483"], "spl_set_id": ["246be926-79ea-4e0c-a3ef-2aa7fc3a52bf"], "manufacturer_name": ["Chain Drug Consortium, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (68016-291-01)  / 28 g in 1 TUBE", "package_ndc": "68016-291-01", "marketing_end_date": "20261231", "marketing_start_date": "20090515"}], "brand_name": "Miconazole", "product_id": "68016-291_421e11c4-085b-4f3d-bbbc-079d4ea522fc", "dosage_form": "CREAM", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "68016-291", "generic_name": "Miconazole Nitrate", "labeler_name": "Chain Drug Consortium, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Miconazole", "active_ingredients": [{"name": "MICONAZOLE NITRATE", "strength": "20 mg/g"}], "application_number": "M005", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_end_date": "20261231", "marketing_start_date": "20090515"}