NTP Formal Name Pattern
No part of the NTP description will be capitalized (with the exception of the “L” as a symbol/abbreviation for “litre” and as in “mL” for millilitre, and for capitalization of single letters as appropriate in a substance name (e.g., penicillin G, abobotulinumtoxinA);
TALLman lettering will not be used;
- Waters of hydration will not be described in NTP substance names (see Appendix C, Hydration and Solvation)
Formal Naming Pattern for Single Active Ingredient Substance NTPs
The following pattern will be used for products with a single active ingredient substance:
<<Basis of Strength Substance (Precise ingredient substance*)>> <<Strength value and unit of measure>> <<Dose Form>> <<Unit of presentation*>>
*included only if required
The following table gives the components required to build a single ingredient NTP formal name, as well as the corresponding NTP formal name:
Basis of Strength Substance (BoSS) | Precise Ingredient Substance | Strength | Dose form | Unit of presentation | NTP_Formal_Name |
|---|---|---|---|---|---|
levothyroxine sodium | same as BoSS | 25 mcg | oral tablet | not explicitly stated | levothyroxine sodium 25 mcg oral tablet |
levothyroxine sodium | same as BoSS | 500 mcg per vial | powder for solution for injection | not required – stated as part of strength (vial) | levothyroxine sodium 500 mcg per vial powder for solution for injection |
atorvastatin | (atorvastatin calcium) | 20 mg | oral tablet | not explicitly stated | atorvastatin (atorvastatin calcium) 20 mg oral tablet |
naproxen | (naproxen, naproxen sodium)* | 200 mg | oral capsule | not explicitly stated | naproxen (naproxen, naproxen sodium) 200 mg oral capsule |
metoclopramide hydrochloride | same as BoSS | 10 mg per 2 mL | solution for injection | vial | metoclopramide hydrochloride 10 mg per 2 mL solution for injection vial |
Formal Naming Pattern for Multiple Active Ingredient Substance NTPs
The early versions of the Canadian Clinical Drug Data Set will exclude products with greater than 5 active ingredients. The following pattern will be used for products with multiple ingredient substances:
<<Basis of Strength Substance A (Precise ingredient substance A)*>> <<Strength value and unit of measure>> <<and>> <<Basis of Strength Substance B (Precise ingredient substance B*) >> <<Strength value and unit of measure>> <<Dose Form>> <<Unit of presentation*>>
*included only if required
The following table gives the components required to build a multi-ingredient NTP formal name, as well as the corresponding NTP formal name:
Basis of Strength Substance | Precise Ingredient Substance | Strength | Dose form | Unit of presentation | NTP_Formal_Name | |
|---|---|---|---|---|---|---|
amlodipine and | (amlodipine besylate) | 10 mg 20 mg | oral tablet | not explicitly stated | amlodipine (amlodipine besylate) 10 mg and atorvastatin (atorvastatin calcium) 20 mg oral tablet | |
formoterol fumarate and | same as BoSS | 5 mcg per actuation | pressurised inhalation | not required – stated as part of strength (actuation) | formoterol fumarate 5 mcg per actuation and mometasone furoate 200 mcg per actuation pressurised inhalation | |
piperacillin and | (piperacillin sodium) | 4 g per vial | powder for solution for injection | not required – stated as part of strength (vial) | piperacillin (piperacillin sodium) 4 g per vial and tazobactam (tazobactam sodium) 0.5 g per vial powder for solution for injection | |
sulfamethoxazole and trimethoprim | same as BoSS | 400 mg per 5 mL | solution for injection | ampoule | sulfamethoxazole 400 mg per 5 mL and trimethoprim 80 mg per 5 mL solution for injection ampoule | |
The following rules will be applied to all multi-ingredient NTPs:
- “and” will be used as the conjunction between active ingredient substances/strengths;
- The order of active ingredient substances in a multi-ingredient NTP will be alphabetical for the formal name; the order of active substances in the French description will follow the order for the corresponding English ingredient names, and therefore ingredients might not appear in alphabetical order in French within multi-ingredient NTPs.