SPL Authoring
Content of Labeling (PI), Carton/Container labels and Patient Package Inserts authored to the latest FDA SPL Implementation Guide — R4 and R5 ready.
FDA · Structured Product Labeling
SPL, done right — XML to ESG.
Structured Product Labeling is the FDA-adopted HL7 XML standard for drug labeling. We author, validate and submit SPLs that keep your product information clear, consistent and audit-ready — and we bridge them to the EU ePI FHIR standard.
Drug Listing & Establishment Registration
Initial and updated drug listings, establishment registration, NDC labeler code reservation and annual reporting via FDA SPL.
Validation
SPL validator runs, schematron and FDA business-rule checks. Zero-error packages before they touch the ESG.
ESG Gateway Submission
Secure transmission of SPL submissions through the FDA Electronic Submissions Gateway with full receipt/acknowledgement tracking.
Lifecycle Messages
Blanket No Change Certifications, NDC reservation updates, label changes, withdrawals — every required SPL lifecycle message handled.
SPL ↔ FHIR Bridge
Mapping SPL XML to the EU ePI HL7 FHIR Common Standard, so the same approved labeling powers both US and EU electronic product information.
Coverage
Every SPL submission type
- NDAs, ANDAs, BLAs
- OTC monograph drugs
- Self-identification SPLs
- NDC reservation
- Blanket No Change Certifications
- Drug establishment registration
Key SPL Sections
- Product Info — proprietary name, strength, dosage form, route.
- Indications & Usage — when and how the product is used.
- Warnings & Precautions — boxed warnings, ADRs, contraindications.
- Drug Interactions — clinically significant interactions.
- Storage & Handling — stability, special handling.
- Manufacturer / Labeler — establishment, NDC, lot.
Deep dives