Structured Product Labeling Services for Accurate FDA Compliance
Axentra provides industry-leading structured product labeling services to ensure your drug listings meet FDA standards. With a focus on compliance and accuracy, our services encompass end-to-end lifecycle management, from NDC creation to post-market oversight. Trust Axentra to deliver reliable solutions, keeping your products FDA-compliant and ready for market. Choose us for unparalleled expertise in structured product labeling services.
Complete Drug Listing & SPL Lifecycle Management
Axentra manages every stage of FDA Drug Listing for prescription, OTC, API, and repackaged drug products—ensuring accurate, compliant, and fully validated SPL submissions. We design correct NDC structures, maintain labeler code integrity, prepare initial listings, and manage all required updates for formulation changes, labeling revisions, package alterations, commercial status changes, and annual certifications. Each SPL is validated for structure, terminology, and content to meet FDA’s electronic submission standards and avoid the errors that often lead to misbranding citations or import holds.
NDC Creation, Updates & Lifecycle Management
Axentra manages every stage of FDA Drug Listing for prescription, OTC, API, and repackaged drug products—ensuring accurate, compliant, and fully validated SPL submissions. We design correct NDC structures, maintain labeler code integrity, prepare initial listings, and manage all required updates for formulation changes, labeling revisions, package alterations, commercial status changes, and annual certifications. Each SPL is validated for structure, terminology, and content to meet FDA’s electronic submission standards and avoid the errors that often lead to misbranding citations or import holds.
NDC Strategy, Labeler Code Management & Compliance Accuracy
Foreign manufacturers frequently struggle with the technical rules behind NDC assignment, labeler code utilization, and the alignment of establishment data with marketed product details. Axentra eliminates this risk by managing NDC planning, preventing code collisions, ensuring correct packager associations, and aligning every SPL with the facility’s Establishment Registration and FEI data. Our expertise extends to correcting legacy listings, resolving inactive or rejected SPLs, and ensuring your products appear accurately in FDA’s NDC Directory and Drug Listing database at all times.
Inspection-Ready Labeling Compliance & Post-Market Oversight
Beyond SPL creation, Axentra ensures your drug listings fully support FDA inspection expectations by aligning SPL text with your approved labeling, promotional claims, and change-control documentation. We proactively monitor FDA guidance, labeling updates, therapeutic class requirements, and electronic submission standards to determine when your listings require revision. Our integrated approach links SPL compliance with facility registration, labeling compliance, and import readiness—providing continuous oversight and reducing regulatory and operational risk across the product lifecycle.
Why Choose Axentra for Drug Listing & SPL Compliance
Expert NDC & Labeler Code Management That Prevents Costly Errors
We design correct NDC structures, maintain labeler code integrity, and prevent code conflicts or misalignments—reducing the risk of listing rejection, import delays, or database inconsistencies.
Fully Validated, FDA-Compliant SPL Submissions Across the Entire Product Lifecycle
Every SPL is technically validated for structure, terminology, dosage form coding, packager association, and regulatory category—ensuring your listings meet FDA’s strict electronic submission standards and remain accurate through all formulation, label, and packaging updates.
Integrated Oversight Connecting SPL, Registration, Labeling & Post-Market Compliance
Axentra links your SPL filings with establishment registration, labeling compliance, and change-control requirements—creating a unified, inspection-ready system that minimizes regulatory risk and keeps your products visible and compliant in FDA’s Drug Listing database.
Drug Listing and SPL submission — Frequently Asked Questions
What is SPL and why does FDA require it?
SPL is the FDA's required XML format for submitting drug listing and labeling information electronically. Every drug listing and update must be filed as a validated SPL.
When must drug registration information be reviewed and updated?
Annually. 21 CFR 207.29 requires that "subsequent reviews and updates must occur annually, during the period beginning on October 1 and ending December 31 of each calendar year". Note this is a yearly review and update cycle, which is different from the biennial renewal that applies to food facilities.
How do I get an NDC labeler code?
The labeler code is the first segment of the National Drug Code and is requested from FDA as part of establishment registration and drug listing. Axentra requests the labeler code, then builds the product and package segments for each SKU and submits the listing in SPL.