For Industry

Pharmaceutical Product Identification

ISO 11616 Pharmaceutical Product Identification (PhPID) provides specific levels of information relevant to the identification of a medicinal product or group of pharmaceutically equivalent medicinal products.

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 determine the pharmaceutical equivalence of medicinal products.  PhPIDs can be generated at four levels for a specific pharmaceutical product across substance(s) and specified substance(s), based on the available information for strength and dosage form. 

PhPID Active Substance Levels:

  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)

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 generates regional PhPIDs to link domestic pharmaceutically equivalent products using Structured Product Labeling (SPL) terminology. A harmonized central terminology for dosage form (DF) and route of administration (RoA), i.e., European Directorate for the Quality of Medicines (EDQM), is required to generate globally unique PhPIDs. CDER’s long-term objective is to harmonize and implement PhPID internationally.

IDMP Standards

 

More in Data Standards

Identification of Medicinal Products (IDMP)

Page Last Updated: 07/09/2018
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