Drug product database: Terminology

Active ingredient

An Active Ingredient is any component that has medicinal properties and supplies pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body of a human or an animal.

The name and strength of each active ingredient contained in the product is listed. Information enclosed within brackets represents the salt and identifies how the ingredient is supplied. This information is only included for some ingredients. The number in the strength field refers to the active portion of the drug. For example, for calcium (calcium carbonate) 200 milligram (mg) - 200 mg is the strength of elemental calcium, not of calcium carbonate.

Health Canada has a reference text hierarchy for ingredient nomenclature. The International Nonproprietary Names (INN) is used as Health Canada's standard to assign the preferred name to ingredients. There are other standards, such as the United States Adopted Names (USAN), Martindale, Merck Index, etc., that are used to code ingredients if they are not listed in the INN. They are also used to maintain a list of synonym in our internal database.

For example, if an ingredient is not found in the INN reference text but is listed in the USAN, then Health Canada would use the USAN as the preferred name until INN lists the ingredient in their reference text. If the ingredient is not found in either the INN or the USAN, then Health Canada hierarchy would be followed and the Martindale reference text would be used. The process would continue until all resources are exhausted and then, in that case, internet reference and/or articles would be used until the ingredient is listed in any of the previous reference texts.

Before 2005, USAN was considered to be Health Canada's nomenclature standard. Therefore, there are some exceptions listed on the Drug Product Database (DPD) Online where the ingredients are coded using that standard.

For more information on INN, please visit this link on the World Health Organization website: INN.

Active Ingredient Group (AIG) Number

The AIG number is a 10-digit number that identifies products that have the same active ingredient(s) and ingredient strength(s). The AIG is comprised of three portions:

• the first portion (2 digits) identifies the number of active ingredients;
• the second portion (5 digits) identifies the unique groups of active ingredients;
• the last portion (3 digits) identifies the active ingredient group strength. The group strength has a tolerance of −2% to +10%.

The AIG structure is illustrated in the examples provided below:

Anatomical Therapeutical Chemical (ATC) Classification System

The purpose of the ATC classification system is to serve as a tool for drug utilization monitoring and research in order to improve quality of drug use.

The classification of a substance in the ATC system is not a recommendation for use, and it does not imply any judgments about the efficacy or relative efficacy of drugs and groups of drugs. In the ATC classification system, drugs are divided into different groups according to the organ or system on which they act and their chemical, pharmacological and therapeutic properties. The drugs are classified in groups at five different levels, as described in the example below:

• A : Alimentary tract and metabolism (1^st level, anatomical main group)
• A10 : Drugs used in diabetes (2^nd level, therapeutic subgroup)
• A10B : Blood glucose lowering drugs, excluding insulins (3^rd level, pharmacological subgroup)
• A10BA : Biguanides (4^th level, chemical subgroup)
• A10BA02 : Metformin (5^th level, chemical substance)

For more information on the ATC classification system, please visit this link on the World Health Organization website: ATC-DDD.

Class of Drug Product

The class identifies whether the drug is for human use, veterinary use, or used as a radiopharmaceutical or a disinfectant.

Description

The description field displays important product information that might differentiate between two very similar products (e.g., same product formulations with or without preservative) or to indicate specific characteristic of a product (e.g., single use syringe).

Drug

According to the Food and Drugs Act, a drug includes any substance or mixture of substances manufactured, sold or represented for use in:

1. the diagnosis, treatment, mitigation or prevention of a disease, disorder, abnormal physical state, or the symptoms thereof in man or animal;
2. restoring, correcting or modifying organic functions in man or animal; or
3. disinfection in premises in which food is manufactured, prepared or kept.

Drug Identification Number (DIN)

A Drug Identification Number (DIN) is a computer-generated eight-digit number assigned by Health Canada to a drug product upon market authorization under subsection C.01.014.2(1) of the Food and Drug Regulations. It uniquely identifies each drug sold in a dosage form in Canada and is located on the package label of prescription and non-prescription drugs that have been evaluated and authorized for sale in Canada.

A DIN uniquely identifies the following product characteristics:

• Product Name;
• Manufacturer Name;
• Active Ingredient(s);
• Strength(s) of Active Ingredient(s);
• Pharmaceutical Form; and
• Route(s) of Administration.

Please note that, as per the Biocides Regulations paragraph 31(1)(d), the designation "DIN" is used along with an eight-digit number on the label of a biocide to represent the biocide's identification number. These numbers are not the same as Drug Identification Numbers (DINs) as biocides are not regulated under the Food and Drug Regulations. Any questions regarding biocides should be directed to the Natural and Non-prescription Health Products Directorate (NNHPD) at nnhpd-dpsnso@hc-sc.gc.ca.

Drug Statuses

The statuses listed below are a direct representation of the statuses available in DPD Online Query and the description of each status is summarized below. For more information on how to search using these statuses, please refer to the Search Tips page.

• Approved: refers to an active DIN for a product that has been reviewed and authorized for sale in Canada but has not yet been marketed in Canada.
• Authorization by Interim Order Revoked: refers to a DIN for which the product authorization has been revoked as per subsection 19(2) and (3) of the Regulations Amending the Food and Drug Regulations (Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19).
• Cancelled Post Market: refers to a DIN that is cancelled further to the discontinuation of the sale of the product by the manufacturer pursuant to subsection C.01.014.6(1)(a) of the Food and Drug Regulations.
• Cancelled Pre Market: refers to a DIN that is cancelled before the product was ever marketed in Canada.
• Cancelled (Safety Issue): refers to a DIN that is cancelled under:
  • Paragraph C.01.014.6(2)(b) of the Food and Drug Regulations due to failure to provide evidence regarding the safety and effectiveness of a drug under section C.01.013 of these Regulations;
  • Paragraph C.01.014.6(2)(b) of the Food and Drug Regulations following the suspension of a Notice of Compliance under section C.08.006 of these Regulations;
  • Paragraph C.01.014.6(3)(a) of the Food and Drug Regulations following the failure to comply with an order issued under section 21.31 of the Food and Drugs Act to conduct an assessment and provide the results; or
  • Paragraph C.01.014.6(3)(b) of the Food and Drug Regulations following the examination of the results of an assessment provided in response to an order issued under section 21.31 of the Food and Drugs Act.
• Cancelled (Transitioned to Biocides): refers to a DIN that is cancelled after having been issued a market authorization under the Biocides Regulations.
• Cancelled (Unreturned Annual): refers to a DIN that is cancelled due to failure to provide the Annual Notification pursuant to paragraph C.01.014.6(2)(a) of the Food and Drug Regulations.
• Dormant: refers to an active DIN for a product that was previously marketed in Canada but for which there have been no sales for a period of at least 12 consecutive months.
• Marketed: refers to an active DIN for a product that is currently being sold in Canada.
• Restricted Access: refers to an active DIN where the sale of the corresponding drug product is restricted to federal, provincial and territorial, and municipal government(s), pursuant to section C.08.002.02 of the Food and Drug Regulations .

Nomenclature Naming

Refer to the Active ingredient text for a detailed explanation.

Number of Active Ingredient(s)

This represents the total number of active (medicinal) ingredient(s) contained in a product.

Pharmaceutical Form

This is the form of presentation in which the product is supplied (e.g., tablet, capsule, powder, etc.)

A product can have more than one dosage form when it is a kit.

Prescribing Information (PI)

Drugs regulated solely under Division 1 of the Food and Drug Regulations are not required to have a product monograph (PM). Rather, many Division 1 drugs have a PI, which includes important information such as the mode of action, indications, contraindications of use, and dosage instructions. This information is helpful for the optimal, safe, and effective use of a drug product, and informs health care professionals and the general public of the authorized conditions of use of a drug. Often, the PI is similar to the package insert included with drug products.

Product Monograph (PM)

A PM is a factual, scientific document about the drug product that is devoid of promotional material. A PM describes the properties, claims, indications, and conditions of use for the drug, and it contains any other information that may be required for optimal, safe, and effective use of the drug. A PM should include appropriate information respecting the name of the drug, its therapeutic or pharmacologic classification, its actions and/or clinical pharmacology, and its indications and clinical uses.

The PM should also include contraindications, warnings, precautions, adverse reactions, drug interactions and effects on laboratory tests, symptoms and treatment of over dosage, dosage and administration, storage and stability, pharmaceutical information, dosage forms, pharmacology, toxicology, microbiology, special handling instructions, information on clinical trials, information for the consumer, references, and the dates of the initial printing and current revision.

Product Name

This is the brand name, as defined in subsection C.01.001(1) of the Food and Drug Regulations, approved by Health Canada under which the drug product may be marketed.

Route of Administration

Indicates the part of the body on which, through which, or into which the product is to be introduced (e.g., oral, topical, intramuscular, rectal).

A product can have more than one route of administration (e.g., intravenous, intramuscular and intra-articular).

Schedule

Each drug product is assigned to one or more of the following schedules or classifications, according to the Controlled Drugs and Substances Act (CDSA), Food and Drugs Act, Food and Drugs Regulations, Narcotic Control Regulations, Benzodiazepines and Other Targeted Substances Regulations, or Health Canada classifications. Note that if multiple schedules could apply to a drug product, then the one with the most stringent regulations or framework that is applicable is selected.

• CDSA Recommended: a drug product that contains one or more substances that are to be added to the Controlled Drugs and Substances Act by way of a regulatory amendment. Once included in the Controlled Drugs and Substances Act, the drug product's schedule is changed to reflect the appropriate schedule.
• Controlled Drugs (CDSA I): a drug product that contains one or more controlled substances listed in Schedule I of the Controlled Drugs and Substances Act and Part G of the Food and Drug Regulations.
• Controlled Drugs (CDSA III): a drug product that contains one or more controlled substances listed in Schedule III of the Controlled Drugs and Substances Act and Part G of the Food and Drug Regulations.
• Controlled Drugs (CDSA IV): a drug product that contains one or more controlled substances listed in Schedule IV of the Controlled Drugs and Substances Act and Part G of the Food and Drugs Regulations.
• Ethical: a drug product that, in accordance with Federal Legislation, does not require a prescription, but that is generally prescribed by a medical practitioner. Ethical products are unscheduled, non-prescription professional use products (e.g., MRI contrast agents, hemodialysis solutions) and a few emergency use products (e.g., nitroglycerine).
• Narcotics (CDSA I): a drug product that contains one or more controlled substances listed in Schedule I of the Controlled Drugs and Substances Act and the Schedule of the Narcotic Control Regulations.
• Narcotics (CDSA II): a drug product that contains one or more controlled substances listed in Schedule II of the Controlled Drugs and Substances Act and the Schedule of the Narcotic Control Regulations.
• Non-Prescription drugs: a drug product that contains one or more substances that do not belong to a schedule in an Act or Regulation, are not included on the Prescription Drug List, and are not scheduled as an Ethical.
• Prescription: a drug product that contains one or more medicinal ingredients that appear on the Prescription Drug List.
• Prescription Recommended: a drug product that contains one or more medicinal ingredients that are recommended to be listed on the Prescription Drug List. Once listed, the drug product's schedule is changed to Prescription.
• Schedule C: a drug product that contains one or more substances that are listed in Schedule C of the Food and Drugs Act and referenced under Part C, Division 3 of the Food and Drug Regulations (e.g., radiopharmaceutical drugs).
• Schedule D: a drug product that contains one or more substances that are listed in Schedule D of the Food and Drugs Act and referenced under Part C, Division 4 of the Food and Drug Regulations (e.g., biologics).
• Targeted Substances (CDSA I): a drug product that contains one or more controlled substances listed in Schedule I of the Controlled Drugs and Substances Act and Part 2 of Schedule 1 of the Benzodiazepines and Other Targeted Substances Regulations.
• Targeted Substances (CDSA IV): a drug product that contains one or more controlled substances listed in Schedule IV of the Controlled Drugs and Substances Act and Part 1 of Schedule 1 of the Benzodiazepines and Other Targeted Substances Regulations .

Status Date

The current status date represents the date of the current status of a product (e.g., when a product was approved, marketed, became dormant, or cancelled in Canada).

The original market date represents the earliest marketed date recorded in the DPD. This is the date when the product first entered the Canadian market.

It is important to note that the date for older products may be listed as a generic date. For example, if the marketed date is listed as 1972.12.31, then it represents the year that the product was marketed in Canada and not necessarily the actual date of December 31, 1972. This strictly happens for older products that were marketed prior to September 1996. This is due to the migration of data from an old system to the DPD. The format of the status date was converted from 'YYYY' to 'YYYY.MM.DD'. To accommodate the DPD's date format, a default date of December 31 was selected. Any products marketed within that year will show December 31, 19XX.

Strength

This refers to the strength of the active ingredient(s). The strength may be reported in a number of ways.

Veterinary Labelling

The veterinary labelling may consist of an outer label, an inner label, and/or a package insert to be used in connection with a veterinary drug. The labels for a veterinary drug must specify adequate directions for use, including withdrawal periods for drugs intended for use in food-producing animals.

A veterinary labelling should include appropriate information respecting the name of the drug, its therapeutic or pharmacologic classification, its actions and/or clinical pharmacology, its indications, its clinical uses and the animal species for which it is authorized. The veterinary labelling could also include contraindications, warnings, cautions, adverse reactions, dosage forms, dosage and administration, microbiology, special handling instructions, and storage and stability.

Veterinary Species

This field displays the type of species for which a veterinary product is authorized (e.g., sheep, dog, cattle, poultry).