NDC 55259-0003 Hantai 8030 Ca-d3 Premium

Ostreae Concha, Calcium

NDC Product Code 55259-0003

NDC CODE: 55259-0003

Proprietary Name: Hantai 8030 Ca-d3 Premium 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.

Non-Proprietary Name: Ostreae Concha, Calcium 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.

Product Characteristics

Color(s):
WHITE (C48325)
Shape: OVAL (C48345)
Size(s):
12 MM

NDC Code Structure

  • 55259 - Apexel Co., Ltd.

NDC 55259-0003-2

Package Description: 1 BOTTLE in 1 PACKAGE > 120 TABLET in 1 BOTTLE

NDC Product Information

Hantai 8030 Ca-d3 Premium with NDC 55259-0003 is a a human over the counter drug product labeled by Apexel Co., Ltd.. The generic name of Hantai 8030 Ca-d3 Premium is ostreae concha, calcium. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Apexel Co., Ltd.

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

Product Type: Human Otc Drug 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.

Hantai 8030 Ca-d3 Premium Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • CALCIUM .99 1/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
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.

  • ZINC OXIDE (UNII: SOI2LOH54Z)
  • MAGNESIUM (UNII: I38ZP9992A)
  • SELENIUM (UNII: H6241UJ22B)
  • GERMANIUM (UNII: 00072J7XWS)
  • IRON (UNII: E1UOL152H7)
  • POTASSIUM (UNII: RWP5GA015D)
  • MANGANESE (UNII: 42Z2K6ZL8P)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Apexel Co., Ltd.
Labeler Code: 55259
Marketing Category: UNAPPROVED DRUG OTHER - 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.

Start Marketing Date: 03-18-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 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.

Exclude Flag: N - NO 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".

* Please review the disclaimer below.

Hantai 8030 Ca-d3 Premium Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient

Ostreae Concha (Calcium 99%)

Inactive Ingredient

Magnesium, Zinc Oxide, Selenium, Germanium, Iron, Potassium, Manganese

Purpose

To prevent and cure the osteoporosis, cardiovascular disorders, depression, nerve stability, muscle pain, arthritis, menstrual pain, ostalgia and promote growth and healing.

Keep Out Of Reach Of Children

Keep out of Reach of Children

Warnings

  • Please note it may choke during the intake tablets. Please check product ingredients if you have any allergies before taking. Please be careful during open the product package. Keep product out of direct sunlight, high temperature and humidity. Store in a cool dry place. Keep out of reach of children. Any items past the expiration date or damaged in transit can be exchanged where you originally purchased the item.

Dosage & Administration

For oral use only

Uses

Take one tablet every time, two times a day with enough water.

* Please review the disclaimer below.