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  4. NDC Product Code: 82160-124 Tacrus

NDC 82160-124 Tacrus

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 82160-124?
  5. Tacrus Uses
  6. Active Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk
  8. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing expired due to lack of listing certification.

Get all the details for National Drug Code (NDC) 82160-124 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
82160-124
Proprietary Name:
Tacrus
Product Type: [3]
Labeler Name: [5]
Pella Pharmaceuticals Co. Ltd
Labeler Code:
82160
Product Label ID:
d0815b7a-46e5-0605-e053-2a95a90a78a8
Marketing Category: [8]
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date: [9]
12-11-2014
Listing Expiration Date: [11]
12-31-2025
Exclude Flag: [12]
U
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325)

Code Structure Chart

Product Details

What is NDC 82160-124?

The NDC code 82160-124 is assigned by the FDA to the product Tacrus which is product labeled by Pella Pharmaceuticals Co. Ltd. The product's dosage form is . The product is distributed in 2 packages with assigned NDC codes 82160-124-01 1 tube in 1 carton / 30 g in 1 tube, 82160-124-02 1 tube in 1 carton / 10 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 Tacrus?

The active substance of Tacrus ®, tacrolimus monohydrate, is an immune-modulating agent. Tacrus ® 0.03% ointment is used to treat moderate to severe atopic dermatitis (eczema) in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids and in children (2 years of age and older) who failed to respond adequately to conventional therapies such as topical corticosteroids. Tacrus ® 0.1 % ointment is used to treat moderate to severe atopic dermatitis (eczema) in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids. Once moderate to severe atopic dermatitis is cleared or almost cleared after up to 6 weeks treatment of a flare, and if you are experiencing frequent flares (i.e. 4 oc more per year), it may be possible to prevent flares coming back or prolong the time you are free from flares by using Tacrus ® 0.1% ointment twice weekly. In atopic dermatitis, an over-reaction of the skin's immune system causes skin inflammation (itchiness, redness, dryness). Tacrus ® alters the abnormal immune response and relieves the skin inflammation and the itch.

Which are Tacrus UNII Codes?

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

What is the NDC to RxNorm Crosswalk for Tacrus?

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:

* Please review the disclaimer below.

Patient Education

Tacrolimus Topical


Tacrolimus ointment is used to treat the symptoms of eczema (atopic dermatitis; a skin disease that causes the skin to be dry and itchy and to sometimes develop red, scaly rashes) in patients who cannot use other medications for their condition or whose eczema has not responded to another medication. Tacrolimus is in a class of medications called topical calcineurin inhibitors. It works by stopping the immune system from producing substances that may cause eczema.
[Learn More]


* 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.

[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

[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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".