Anatomy of the SPL File


A

Term
Definition, Expansion, Example

B




C





D

D-U-N-S Number
Each business location (e.g., headquarters, branch, subsidiary, establishment, importer, US agent) has its own unique site specific DUNS Number.


E

Effective Time
The effective time provides a date reference to the SPL version.
The date includes the year, month and day using the format yyyymmdd.


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G




H



I

ID Root
The id root uniquely identifies a specific SPL file.
Each new version of an SPL file has a new id root.
The id root is a Globally Unique Identifier (GUID).

J



K



L

Labeler Name
The labeler is the registrant or private label distributor requesting the NDC Labeler Code. The information includes the labeler name and DUNS Number.1

M



N



O



P



Q



R



S

Setid Root
The setId root uniquely identifies a group of versions of an SPL file. When an SPL file changes a new id root is assigned to the new SPL file but the setId root in the original SPL file is used. Like the id root, the setId root is a GUID.
Source NDC
The source code is NDC Product Code for a Source Drug Repacked or Relabeled
Repackers and relabelers may submit the NDC Product Code for the source drug that is repacked or relabeled to reference previously submitted manufacturing establishment information.

T

Type of Document

U



V

Version Number
The 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.

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X



Y




Z