vagisil brand vagistat

Generic: miconazole nitrate

Labeler: combe incorporated
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name vagisil brand vagistat
Generic Name miconazole nitrate
Labeler combe incorporated
Dosage Form CREAM
Routes
VAGINAL
Active Ingredients

miconazole nitrate 2 g/100g

Manufacturer
Combe Incorporated

Identifiers & Regulatory

Product NDC 11509-0825
Product ID 11509-0825_42a55863-e89f-4ec0-97a0-2d7b1e2b6b36
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA074760
Listing Expiration 2026-12-31
Marketing Start 2020-10-08

Pharmacologic Class

Classes
azole antifungal [epc] azoles [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 115090825
Hyphenated Format 11509-0825

Supplemental Identifiers

RxCUI
998540 1359442
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 vagisil brand vagistat (source: ndc)
Generic Name miconazole nitrate (source: ndc)
Application Number ANDA074760 (source: ndc)
Routes
VAGINAL
source: ndc

Resolved Composition

Strengths
  • 2 g/100g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (11509-0825-1) / 45 g in 1 TUBE
source: ndc

Packages (1)

11509-0825-1 1 TUBE in 1 CARTON (11509-0825-1) / 45 g in 1 TUBE

Ingredients (1)

miconazole nitrate (2 g/100g)

Linked Drug Pages (1)

vagisil brand vagistat ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["VAGINAL"], "spl_id": "42a55863-e89f-4ec0-97a0-2d7b1e2b6b36", "openfda": {"unii": ["VW4H1CYW1K"], "rxcui": ["998540", "1359442"], "spl_set_id": ["833a5e4d-0591-4300-8f9c-fd00ffaf6041"], "manufacturer_name": ["Combe Incorporated"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (11509-0825-1)  / 45 g in 1 TUBE", "package_ndc": "11509-0825-1", "marketing_start_date": "20201008"}], "brand_name": "vagisil brand vagistat", "product_id": "11509-0825_42a55863-e89f-4ec0-97a0-2d7b1e2b6b36", "dosage_form": "CREAM", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "11509-0825", "generic_name": "Miconazole nitrate", "labeler_name": "Combe Incorporated", "product_type": "HUMAN OTC DRUG", "brand_name_base": "vagisil brand vagistat", "active_ingredients": [{"name": "MICONAZOLE NITRATE", "strength": "2 g/100g"}], "application_number": "ANDA074760", "marketing_category": "ANDA", "marketing_start_date": "20201008", "listing_expiration_date": "20261231"}