U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

  1. Home
  2. For Industry
  3. FDA Data Standards Advisory Board
  4. Structured Product Labeling Resources
  5. Combination Product Types
  1. Structured Product Labeling Resources

Combination Product Types

Source: National Cancer Institute Thesaurus

NCI Thesaurus OID: 2.16.840.1.113883.3.26.1.1

 

SPL Acceptable Term

Code

Type 0: Not a Combination ProductC112160
Type 1: Convenience Kit of Co-PackageC102834
Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)C102835
Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)C102836
Type 4: Device Coated/Impregnated/Otherwise Combined with DrugC102837
Type 5: Device Coated or Otherwise Combined with BiologicC102838
Type 6: Drug/Biologic CombinationC102839
Type 7: Separate Products Requiring Cross LabelingC102840
Type 8: Possible Combination Based on Cross Labeling of Separate Products (Temporary Type)C102841
Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)C102842

 

Back to Top