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SPL

The FDA requires a “Stuctured Product Labeling” (SPL) for the registration of medicinal products.

UNII Substances
Unique Ingredient Identifier – a non-proprietary, free, unique, unambiguous, nonsemantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. The substances are to be coded by a UNII code.

Country Codes
SPL represents countries with ISO 3166-1 Alpha-3 country codes

SPL – Drug Route of Administration Terminology
Terminology used for representation of the information on pharmaceutical product route of administration in the framework of the Structured Product Labeling documents.
SPL Pharmaceutical Dosage Form Terminology
Terminology used for representation of the information on pharmaceutical product dosage form in the framework of the Structured Product Labeling documents.

SPL Package Type Terminology
Terminology used for representation of the information on pharmaceutical product package type in the framework of the Structured Product Labeling documents.

SPL Unit of Presentation Terminology
Terminology that encompasses dosage form, package type, and unit of measurement (aka potency) terms used in supporting regulatory submissions in electronic format such as drug establishment registration and drug listing.

SPL Unit of Measure Terminology
Terminology that represents units of measure in supporting regulatory submissions in electronic format such as drug establishment registration and drug listing.

Download SPL Controlled Vocabularies from IDMP1:

SPL´s data are actualised by the FDA regularly. Please license our service download SPL Controlled Vocabularies to get noticed the moment the terms and the download files are actualised and to download the actual files.

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