Avedana Hemorrhoidal
NDC 43749-470

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 43749-470?
  5. Avedana Hemorrhoidal Maximum Strength Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes

Product Information

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

Avedana Hemorrhoidal is a OTC MONOGRAPH DRUG-approved product labeled by Unipack Llc. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a white product. This product entry covers the primary NDC 43749-470 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
43749-470
Proprietary Name:
Avedana Hemorrhoidal Maximum Strength
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:

Labeler & Regulatory Data

Labeler Name: [5]
Unipack Llc
Labeler Code:
43749
Product Label ID:
de618ae6-db79-4392-b30e-34a6bdcb1376
FDA Application Number: [6]
M015
Marketing Category: [8]
OTC MONOGRAPH DRUG

Marketing Timeline

Start Marketing Date: [9]
11-04-2020
Listing Expiration Date: [11]
12-31-2025
Exclude Flag: [12]
I

Product Characteristics

Color(s):
WHITE (C48325)

Code Structure Chart

Product Details

What is NDC 43749-470?

The NDC code 43749-470 is assigned by the FDA to the product Avedana Hemorrhoidal Maximum Strength. This pharmaceutical product is labeled by Unipack Llc and is currently categorized as listed product. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 43749-470-01, 43749-470-02. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

-adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe.  Gently dry by patting or blotting with a tissue or a soft cloth before applying cream.  When first opening the tube, puncture foil seal with top end of cap.  Apply externally or in the lower portion of the anal canal only.  Apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement. -For application in the lower anal canal: remove cover from dispensing cap.  Attach dispensing cap to tube.  Lubrcate dispensing cap well, then gently insert dispensing cap partway into the anus.-thoroughly cleanse dispensing cap after each use and replace cover.-children under 12 years of age: ask a doctor. Apply externally or in the lower portion of the anal canal only. Apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement.-For application in the lower anal canal: remove cover from dispensing cap. Attach dispensing cap to tube. Lubrcate dispensing cap well, then gently insert dispensing cap partway into the anus.

Which are the associated UNII Codes?

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

Which are the Inactive Ingredients associated 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:

* Please review the full disclaimer at the bottom of this page.

Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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".