NDC 57501-006 Monistat 3 Combination Pack

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
57501-006
Proprietary Name:
Monistat 3 Combination Pack
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Apex International Mfg., Inc.
Labeler Code:
57501
Start Marketing Date: [9]
06-11-2020
Listing Expiration Date: [11]
12-31-2021
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325)

Product Packages

NDC Code 57501-006-01

Package Description: 1 KIT in 1 PACKAGE, COMBINATION * 5 g in 1 APPLICATOR * 9 g in 1 TUBE

Product Details

What is NDC 57501-006?

The NDC code 57501-006 is assigned by the FDA to the product Monistat 3 Combination Pack which is product labeled by Apex International Mfg., Inc.. The product's dosage form is . The product is distributed in a single package with assigned NDC code 57501-006-01 1 kit in 1 package, combination * 5 g in 1 applicator * 9 g in 1 tube. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Monistat 3 Combination Pack?

Before using this product read the enclosed consumer information leaflet for complete directions and informationadults and children 12 years of age and over:applicators: insert 1 suppository into the vagina at bedtime for 3 nights in a row. Throw away applicator after use. external cream: squeeze a small amount of cream onto your fingertip. Apply the cream onto the itchy, irritated skin outside the vagina. Use 2 times daily for up to 7 days, as needed. children under 12 years of age: ask a doctor

Which are Monistat 3 Combination Pack UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Monistat 3 Combination Pack Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Monistat 3 Combination Pack?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 992765 - miconazole nitrate 200 MG Vaginal Insert
  • RxCUI: 992766 - {1 (9000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream) / 3 (miconazole nitrate 200 MG Vaginal Insert) } Pack
  • RxCUI: 992766 - miconazole nitrate 200 MG Vaginal Insert (3) / miconazole nitrate 2 % Vaginal Cream (9 GM) Pack
  • RxCUI: 992766 - miconazole 3 Day (3 - 200 MG miconazole nitrate vaginal insert / 9 GM miconazole nitrate 2 % topical vaginal cream)
  • RxCUI: 992766 - miconazole 3 Day Vaginal Insert Combination Pack

* Please review the disclaimer below.

Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".