Great Calcium Tablet
NDC 55259-1161
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
Great Calcium (ostreae concha) is a UNAPPROVED DRUG OTHER-approved product labeled by Apexel Co., Ltd.. This medication is typically used as a calcium [cs]. It is supplied as a white tablet for oral administration. This product entry covers the primary NDC 55259-1161 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
55259-1161
Proprietary Name:
Great Calcium
Non-Proprietary Name: [1]
Ostreae Concha
Substance Name: [2]
Calcium
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:
Clinical Specifications
Dosage Form:
Tablet
- A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
55259
Product Label ID:
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]
11-18-2018
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N
Product Characteristics
Color(s):
WHITE (C48325)
Shape:
OVAL (C48345)
Size(s):
12 MM
Code Structure Chart
Product Details
What is NDC 55259-1161?
The NDC code 55259-1161 is assigned by the FDA to the product Great Calcium. It is commonly known by its generic name, ostreae concha. This pharmaceutical product is labeled by Apexel Co., Ltd. and is currently categorized as listed product. The medication is a tablet administered via oral route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 55259-1161-1. 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?
This product is used as Treatment and prevention of osteoporosisGrowth and developmentTreatment and prediction of cardiovascular disease due to calcification of bloodAttention deficit in children, depression, nervous symptoms, nervous stability to anxietyMyalgia, Bone Pain, Arthritis, Dysmenorrhea Treatment. For oral use only
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.
- CALCIUM .76 mg/1 - A basic element found in nearly all tissues. It is a member of the alkaline earth family of metals with the atomic symbol Ca, atomic number 20, and atomic weight 40. Calcium is the most abundant mineral in the body and combines with phosphorus to form calcium phosphate in the bones and teeth. It is essential for the normal functioning of nerves and muscles and plays a role in blood coagulation (as factor IV) and in many enzymatic processes.
Which are the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- CALCIUM (UNII: SY7Q814VUP)
- CALCIUM (UNII: SY7Q814VUP) (Active Moiety)
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:
- MAGNESIUM (UNII: I38ZP9992A)
- PANAX GINSENG WHOLE (UNII: 9L5JEP7MES)
- VITAMIN D (UNII: 9VU1KI44GP)
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".
