vagistat 3

Generic: miconazole nitrate

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

Drug Facts

Product Profile

Brand Name vagistat 3
Generic Name miconazole nitrate
Labeler combe incorporated
Dosage Form KIT
Manufacturer
Combe Incorporated

Identifiers & Regulatory

Product NDC 11509-0081
Product ID 11509-0081_9181ac4a-a921-4c23-a199-eb62910b33f5
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA075329
Listing Expiration 2026-12-31
Marketing Start 2018-03-27

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 115090081
Hyphenated Format 11509-0081

Supplemental Identifiers

RxCUI
992765 992766 992791 992792 998540 1359442

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 vagistat 3 (source: ndc)
Generic Name miconazole nitrate (source: ndc)
Application Number ANDA075329 (source: ndc)

Resolved Composition

Strengths
  • 200 mg
  • 2 %
source: label
Packaging
  • 1 KIT in 1 CARTON (11509-0081-1) * 3 BLISTER PACK in 1 KIT / 1 SUPPOSITORY in 1 BLISTER PACK * 1 TUBE in 1 KIT / 9 g in 1 TUBE
source: ndc

Packages (1)

11509-0081-1 1 KIT in 1 CARTON (11509-0081-1) * 3 BLISTER PACK in 1 KIT / 1 SUPPOSITORY in 1 BLISTER PACK * 1 TUBE in 1 KIT / 9 g in 1 TUBE

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

VAGISTAT 3 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "9181ac4a-a921-4c23-a199-eb62910b33f5", "openfda": {"rxcui": ["992765", "992766", "992791", "992792", "998540", "1359442"], "spl_set_id": ["e15a28cd-9e64-4e9e-8df9-829d84f1816c"], "manufacturer_name": ["Combe Incorporated"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (11509-0081-1)  *  3 BLISTER PACK in 1 KIT / 1 SUPPOSITORY in 1 BLISTER PACK *  1 TUBE in 1 KIT / 9 g in 1 TUBE", "package_ndc": "11509-0081-1", "marketing_start_date": "20180327"}], "brand_name": "VAGISTAT 3", "product_id": "11509-0081_9181ac4a-a921-4c23-a199-eb62910b33f5", "dosage_form": "KIT", "product_ndc": "11509-0081", "generic_name": "Miconazole nitrate", "labeler_name": "Combe Incorporated", "product_type": "HUMAN OTC DRUG", "brand_name_base": "VAGISTAT 3", "application_number": "ANDA075329", "marketing_category": "ANDA", "marketing_start_date": "20180327", "listing_expiration_date": "20261231"}