Hautuki Wellness Patch
NDC 83463-0003

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 83463-0003?
  4. Hautuki Wellness Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. Pharmacologic Classes

Product Information

Hautuki Wellness (vitamin d3, vitamin k2) is a UNAPPROVED DRUG OTHER-approved product labeled by Custics. This medication is typically used as a vitamin d [cs]. It is supplied as a patch for transdermal administration. This product entry covers the primary NDC 83463-0003 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
83463-0003
Proprietary Name:
Hautuki Wellness
Non-Proprietary Name: [1]
Vitamin D3, Vitamin K2
Substance Name: [2]
Cholecalciferol; Menaquinone 6
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Patch - A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms ‘extended release film’ and ‘system’.
Administration Route(s): [4]
Transdermal - Administration through the dermal layer of the skin to the systemic circulation by diffusion.

Labeler & Regulatory Data

Labeler Name: [5]
Custics
Labeler Code:
83463
Product Label ID:
4e71871f-d443-e226-e063-6294a90a160b
Marketing Category: [8]
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.

Marketing Timeline

Start Marketing Date: [9]
03-01-2026
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 83463-0003?

The NDC code 83463-0003 is assigned by the FDA to the product Hautuki Wellness. It is commonly known by its generic name, vitamin d3, vitamin k2. This pharmaceutical product is labeled by Custics and is currently categorized as listed product. The medication is a patch administered via transdermal route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 83463-0003-1. 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?

# Suggested areas of application e.g., back of hand, forearm, around knee, back of foot. Avoid using lotions or creams on the application area, as they may hinder absorption. Patches are water-resistant, not waterproof. # Suggested Use Children 4 yrs & older Use for up to 4 hours per day # Suggested areas e.g., back of hand, forearm, around knee, back of foot.

What are Active Ingredients of this product?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • CHOLECALCIFEROL .1 mg/100g - Derivative of 7-dehydroxycholesterol formed by ULTRAVIOLET RAYS breaking of the C9-C10 bond. It differs from ERGOCALCIFEROL in having a single bond between C22 and C23 and lacking a methyl group at C24.
  • MENAQUINONE 6 .2 mg/100g - RN given refers to (all-E)-isomer

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:

Which are the Pharmacologic Classes of this product?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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".