NDC 55259-0002 7030 Calcium Premium

Calcium

NDC Product Code 55259-0002

NDC CODE: 55259-0002

Proprietary Name: 7030 Calcium 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: 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 - WHITE)
Shape: OVAL (C48345)
Size(s):
12 MM
Imprint(s):
3;HP;X
Score: 1

NDC Code Structure

  • 55259 - Apexel Co., Ltd

NDC 55259-0002-1

Package Description: 120 CAPSULE in 1 PACKAGE

NDC Product Information

7030 Calcium Premium with NDC 55259-0002 is a a human over the counter drug product labeled by Apexel Co., Ltd. The generic name of 7030 Calcium Premium is calcium. The product's dosage form is capsule and is administered via oral form.

Labeler Name: Apexel Co., Ltd

Dosage Form: Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.

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.

7030 Calcium 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.

  • MAGNESIUM (UNII: I38ZP9992A)
  • ZINC OXIDE (UNII: SOI2LOH54Z)
  • 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.

7030 Calcium Premium Product Label Images

7030 Calcium 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

Otc - Active Ingredient

Calcium

Inactive Ingredient

Magnesium, zinc oxide, selenium, germanium, iron, potassium, manganese

Otc - Purpose

- to prevent and cure the osteoporosis


- to prevent and cure the disease of cardiac and vascular


- to promote growth and healing

Otc - Keep Out Of Reach Of Children

Keep out of reach of the children

Indications & Usage

Take two tablets everty time, two times a day with enough water

Warnings

• Do not use during pregnant, breast-feeding, or menstrual cycle


• Keep this product out of reach of children under 3 years old

Dosage & Administration

For oral use only

* Please review the disclaimer below.