NDC 54868-5041 Amnesteem

Table of Contents

    1. Product Information
    2. Product Packages
    3. Product Characteristics
    4. What is NDC 54868-5041?
    5. Amnesteem Uses
    6. Active Ingredients UNII Codes
    7. Inactive Ingredients UNII Codes
    8. NDC to RxNorm Crosswalk

Product Information

NDC Product Code54868-5041
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.		Amnesteem
NDC Directory StatusINACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		Physicians Total Care, Inc.
Labeler Code54868
SPL SET ID:0018861f-1b9b-431b-84ee-9d34aab615c3
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.		09-14-2009
Listing Expiration Date 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.		12-31-2017
Exclude Flag 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". 		I
NDC Code Structure

Product Characteristics

Color(s)RED (C48326 - REDDISH BROWN)
WHITE (C48325 - CREAM)
ShapeCAPSULE (C48336)
Size(s)9 MM
13 MM
Imprint(s)I10
I20
Score1

Product Packages

NDC Code 54868-5041-0

Package Description: 3 BLISTER PACK in 1 CARTON / 10 CAPSULE in 1 BLISTER PACK

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Product Details

What is NDC 54868-5041?

The NDC code 54868-5041 is assigned by the FDA to the product Amnesteem which is product labeled by Physicians Total Care, Inc.. The product's dosage form is . The product is distributed in a single package with assigned NDC code 54868-5041-0 3 blister pack in 1 carton / 10 capsule in 1 blister pack. 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 Amnesteem?

This medication is used to treat severe cystic acne (also known as nodular acne) that has not responded to other treatment (e.g., benzoyl peroxide or clindamycin applied to the skin or tetracycline or minocycline taken by mouth). It belongs to a class of drugs known as retinoids. It works by decreasing facial oil (sebum) production. High amounts of sebum can lead to severe acne. If left untreated, severe acne may cause permanent scarring.

Which are Amnesteem UNII Codes?

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

Which are Amnesteem 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 Amnesteem?

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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Product Label

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