NDC 16110-812 Fluoroplex

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:
16110-812
Proprietary Name:
Fluoroplex
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Almirall, Llc
Labeler Code:
16110
Start Marketing Date: [9]
12-03-1993
Listing Expiration Date: [11]
12-31-2023
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Packages

NDC Code 16110-812-30

Package Description: 1 TUBE in 1 CARTON / 30 g in 1 TUBE

Product Details

What is NDC 16110-812?

The NDC code 16110-812 is assigned by the FDA to the product Fluoroplex which is product labeled by Almirall, Llc. The product's dosage form is . The product is distributed in a single package with assigned NDC code 16110-812-30 1 tube in 1 carton / 30 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 Fluoroplex?

FLUOROPLEX® Cream is indicated for the topical treatment of multiple actinic (solar) keratoses.

Which are Fluoroplex UNII Codes?

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

Which are Fluoroplex 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 Fluoroplex?

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

Fluorouracil Topical


Fluorouracil cream and topical solution are used to treat actinic or solar keratoses (scaly or crusted lesions [skin areas] caused by years of too much exposure to sunlight). Fluorouracil cream and topical solution are also used to treat a type of skin cancer called superficial basal cell carcinoma if usual types of treatment cannot be used. Fluorouracil is in a class of medications called antimetabolites. It works by killing fast-growing cells such as the abnormal cells in actinic keratoses and basal cell carcinoma.
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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".