General Data
FDA SPL for SPL R4 - Structured Product Labeling - User Manual

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Under "General Data" the SPL Document Information such as Document Type, ID, Title and Version can be added.
See Introduction to SPL R4 for allowed Document Types.

General DataGeneral SPL Document Information such as ID, Title, Version etc.
Document Type CodeSPL Document Type Code - check http://www.fda.gov for details
Document Type NameSPL Document Type Name - check http://www.fda.gov for details
Document IDThe Document ID uniquely identifies a specific SPL file. Each new version of an SPL file has a new Document ID. SPL XML File must be named same as the Document ID.
TitleGeneral text, the Document title
Effective TimeThe Effective Time provides a date reference to the SPL version. The date includes the year, month and day using the format yyyymmdd
Availability TimeThe Availabilty Time provides a date reference to the SPL version. The date includes the year, month and day using the format yyyymmdd
ConfidentialityB=Business Confidentiality - if not confidential then remove information
Set IDThe Set ID uniquely identifies a group of versions of an SPL file. When an SPL file changes a new Document ID is assigned to the new SPL file but the Set ID in the original SPL file is used.
Version NumberThe version number provides an order for different versions of an SPL file. The version number is a whole number greater than zero. The version number is increased with each change.

(c) sartori-software.com 2018