NDC 77338-165 Astonea Miconazole Nitrate

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:
77338-165
Proprietary Name:
Astonea Miconazole Nitrate
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Astonea Labs Private Limited
Labeler Code:
77338
Start Marketing Date: [9]
08-19-2022
Listing Expiration Date: [11]
12-31-2023
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Packages

NDC Code 77338-165-03

Package Description: 85 g in 1 BOTTLE, PLASTIC

Product Details

What is NDC 77338-165?

The NDC code 77338-165 is assigned by the FDA to the product Astonea Miconazole Nitrate which is product labeled by Astonea Labs Private Limited. The product's dosage form is . The product is distributed in a single package with assigned NDC code 77338-165-03 85 g in 1 bottle, plastic . 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 Astonea Miconazole Nitrate?

Clean the affected area & dry thoroughlyapply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctorsupervise children in the use of this productfor athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, & change shoes & socks at least once dailyfor athlete's foot & ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeksif condition persists longer, consult a doctorthis product is not effective on the scalp or nails

Which are Astonea Miconazole Nitrate UNII Codes?

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

Which are Astonea Miconazole Nitrate 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 Astonea Miconazole Nitrate?

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:

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Patient Education

Miconazole Topical


Topical miconazole is used to treat tinea corporis(ringworm; fungal skin infection that causes a red scaly rash on different parts of the body), tinea cruris (jock itch; fungal infection of the skin in the groin or buttocks), and tinea pedis (athlete's foot; fungal infection of the skin on the feet and between the toes). Miconazole is in a class of antifungal medications called imidazoles. It works by stopping the growth of fungi that cause infection. Not all products should be used to treat all of these conditions. Please read the label for each product to select the one to treat your condition.
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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".