Pharmaceutical Product Identification

ISO 11616 Pharmaceutical Product Identification (PhPID) can be used to associate products with same or similar pharmaceutical composition. The PhPID is a unique identifier calculated by an algorithm based on substance identification (ISO 11238), dosage form (ISO 11239) and strengths with units of measurement (ISO 11240), to associate group of relevant medicinal products at specific levels. PhPIDs are generated at four levels for a specific pharmaceutical product across substance(s) and specified substance(s) two strata..

PhPID Active Substance stratum:

1. Level 1 — substance(s) term (ISO 11238)
2. Level 2 — substance term(s) + strength + reference strength (ISO 11238, ISO 11240)
3. Level 3 — substance term(s) + dosage form (ISO 11238, ISO 11239)
4. Level 4 — substance(s) term + strength + reference strength + dosage form (ISO 11238, ISO 11239, ISO 11240)

 PhPID Specified Substance stratum:

1. Level 1 — specified substance(s) term (ISO 11238)
2. Level 2 — specified substance term(s) + strength + reference strength (ISO 11238, ISO 11240)
3. Level 3 — specified substance term(s) + dosage form (ISO 11238, ISO 11239)
4. Level 4 — specified substance(s) term + strength + reference strength + dosage form (ISO 11238, ISO 11239, ISO 11240)

Example of PhPID levels:

PhPID Level 1
Substance: Acetaminophen

 

 

PhPID Level 2
Substance: Acetaminophen
Strength: 500
Unit: mg

PhPID Level 3
Substance: Acetaminophen
Dosage Form: Tablet

 

PhPID Level 4
Substance: Acetaminophen
Dosage Form: Tablet
Strength: 500

Currently, FDA can generate regional PhPIDs to link domestic medicinal products using Structured Product Labeling (SPL) terminology. A harmonized central terminology for dosage form (DF) and route of administration (RoA) is required to generate globally unique PhPIDs. FDA’s long-term objective is to harmonize and implement PhPID internationally.