LOINCActiveObservation

LOINC Code 85274-9: FDA package insert REMS release

85274-9 is a LOINC code used to identify FDA package insert REMS release in laboratory and clinical observation data. You may see this code in lab systems, lab reports, EHR exports, interoperability feeds, or other structured clinical data exchanges. LOINC codes identify tests, measurements, observations, survey items, and clinical questions in a standardized way. It is associated with the component REMS Release. It is commonly used with the system or sample type ^FDA package insert.

Reviewed by HealthAssure Clinical TeamUpdated 21 May 2026

What is this code?

LOINC codes identify tests, measurements, observations, survey items, and clinical questions in a standardized way. It is associated with the component REMS Release. It is commonly used with the system or sample type ^FDA package insert.

When is it used?

  • Used in lab systems, EHRs, and clinical data exchange.
  • May identify a test, observation, survey item, or clinical document request rather than a diagnosis.
  • Status: ACTIVE
  • Order vs observation: Observation

What it does not mean

  • The code identifies the observation or test, not the actual result.

Key facts

  • FDA package insert REMS release
  • REMS Release
  • DOCUMENT.REF; FDA insert; SPL; Structured Product Labelling

Where you may see this code

You may see this code in lab systems, lab reports, EHR exports, interoperability feeds, or other structured clinical data exchanges.

Common synonyms

FDA package insert REMS releaseFDA insert REMS releaseREMS ReleaseDOC.REF-^FDA package insert

Frequently asked questions

Code details

Code85274-9
SystemLOINC
Display nameFDA package insert REMS release
DescriptionREMS Release
Short nameFDA insert REMS release
ComponentREMS Release
Property-
Timing-
System (specimen)^FDA package insert
Scale-
ClassDOC.REF
StatusACTIVE
Order/ObservationObservation

Flags

BillableNo
Valid clinical useNo

Source

SourceLOINC
Version2.82
Releasemain
First released2.61
Last changed2.61

Part names

REMS release-^FDA package insert

About this content

This page is prepared by HealthAssure's clinical team using official coding standards from LOINC. AI tools assist with drafting explanations, which are then reviewed and verified by healthcare professionals for accuracy. This content is for informational purposes and does not replace professional medical advice. Meet our team.

LOINC Code 85274-9 | HealthAssure