FDA · SPL

SPL authoring R4 and R5 ready.

Structured Product Labeling is the FDA-adopted HL7 XML standard for drug labeling. Alnexia authors SPL XML directly from approved USPI, MedGuide, PPI and packaging content — clean, validated, and ESG-ready.

Capabilities

What we deliver

Content of Labeling

Full PI / USPI rendered as compliant SPL XML with correct LOINC section codes.

Carton & container labels

Principal Display Panel content captured as SPL multimedia and code references.

Patient labeling

MedGuide, PPI and IFU sections embedded per FDA expectations.

Code system lookups

NDC, UNII, RxNorm, SNOMED CT and LOINC values resolved and version-locked.

Lifecycle messages

Initial submissions, replace, withdraw and Blanket No Change Certifications.

Validation

Schematron, SPL business rules and FDA validator clean before hand-off.

Deliverables

Artefacts you receive

SPL XML package
Validation report
Code-system reference list
Cover letter & FDA forms

References & standards

Sourced from regulators and industry leaders

FDA SPL Implementation Files & IG — U.S. FDA
HL7 SPL R5 — HL7

Ready to scope this work?

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