NDC 68428-036 Calcarea Carbonica Kit Refill
Oyster Shell Calcium Carbonate, Crude Pellet Oral

Product Information

What is NDC 68428-036?

The NDC code 68428-036 is assigned by the FDA to the product Calcarea Carbonica Kit Refill which is a human over the counter drug product labeled by Washington Homeopathic Products. The generic name of Calcarea Carbonica Kit Refill is oyster shell calcium carbonate, crude. The product's dosage form is pellet and is administered via oral form. The product is distributed in a single package with assigned NDC code 68428-036-01 750 pellet in 1 vial, glass . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code68428-036
Proprietary Name 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.
Calcarea Carbonica Kit Refill
Non-Proprietary Name 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.
Oyster Shell Calcium Carbonate, Crude
Product Type 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.
Human Otc Drug
Dosage FormPellet - A small sterile solid mass consisting of a highly purified drug (with or without excipients) made by the formation of granules, or by compression and molding.
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.
Washington Homeopathic Products
Labeler Code68428
Marketing Category 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.
UNAPPROVED HOMEOPATHIC -
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
05-03-2010
Listing Expiration Date 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.
12-31-2023
Exclude Flag 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".
N
NDC Code Structure

What are the uses for Calcarea Carbonica Kit Refill?


Product Characteristics

Color(s)WHITE (C48325 - WHITE)

Product Packages

NDC Code 68428-036-01

Package Description: 750 PELLET in 1 VIAL, GLASS

Product Details

What are Calcarea Carbonica Kit Refill Active Ingredients?

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.

Calcarea Carbonica Kit Refill Active Ingredients UNII Codes

  • OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I)
  • OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (Active Moiety)

Calcarea Carbonica Kit Refill Inactive Ingredients 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.

* Please review the disclaimer below.

Calcarea Carbonica Kit Refill Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Uses



To relieve the symptoms of overwork.


Keep Out Of Reach Of Children



Keep this and all medicines out of reach of children.


Stop Use And Ask Doctor



If symptoms persist/worsen or if pregnant/nursing, stop use and consult your practitioner.


Inactive Ingredients



Sucrose/Lactose


* Please review the disclaimer below.