miconazole nitrate

Generic: miconazole nitrate

Labeler: actavis pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name miconazole nitrate
Generic Name miconazole nitrate
Labeler actavis pharma, inc.
Dosage Form SUPPOSITORY
Routes
VAGINAL
Active Ingredients

miconazole nitrate 200 mg/1

Manufacturer
Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 0472-1738
Product ID 0472-1738_bb1aad58-4ca7-4be9-8649-0f29e22b81f5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA073508
Listing Expiration 2026-12-31
Marketing Start 1995-01-18

Pharmacologic Class

Classes
azole antifungal [epc] azoles [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04721738
Hyphenated Format 0472-1738

Supplemental Identifiers

RxCUI
992765
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 ANDA073508 (source: ndc)
Routes
VAGINAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 3 SUPPOSITORY in 1 CARTON (0472-1738-03)
source: ndc

Packages (1)

0472-1738-03 3 SUPPOSITORY in 1 CARTON (0472-1738-03)

Ingredients (1)

miconazole nitrate (200 mg/1)

Linked Drug Pages (1)

Miconazole Nitrate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["VAGINAL"], "spl_id": "bb1aad58-4ca7-4be9-8649-0f29e22b81f5", "openfda": {"unii": ["VW4H1CYW1K"], "rxcui": ["992765"], "spl_set_id": ["aa9e250b-f317-42cb-b8d2-e85de56f4ef7"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 SUPPOSITORY in 1 CARTON (0472-1738-03)", "package_ndc": "0472-1738-03", "marketing_start_date": "19950118"}], "brand_name": "Miconazole Nitrate", "product_id": "0472-1738_bb1aad58-4ca7-4be9-8649-0f29e22b81f5", "dosage_form": "SUPPOSITORY", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "0472-1738", "generic_name": "Miconazole Nitrate", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Miconazole Nitrate", "active_ingredients": [{"name": "MICONAZOLE NITRATE", "strength": "200 mg/1"}], "application_number": "ANDA073508", "marketing_category": "ANDA", "marketing_start_date": "19950118", "listing_expiration_date": "20261231"}