The Digital Twin.
Every drug product must be 'listed' with FDA using Structured Product Labeling (SPL). We transform your physical label into the XML code FDA requires.
<id root='2.16.840...'/>
<code code='34391-3'/>
<title>Drug Label</title>
<author>
<assignedEntity>
<representedOrganization>
<id extension='123...'/>
<name>Pharma Inc</name>
</representedOrganization>
</assignedEntity>
</author>
<component>
<structuredBody>
<component>
<section>
<code code='42229-5'/>
<title>SPL UNCLASSIFIED</title>
Active vs. Inactive.
SPL requires every ingredient to be identified by a Unique Ingredient Identifier (UNII). We map your formula against the FDA Substance Registration System (SRS) to ensure perfect matching.
Select Dosage Form
SPL requires precise NCI Thesaurus codes.
Dosage Form.
Is it a Tablet or a Capsule? A Cream or a Lotion? FDA has strict definitions (NCI Thesaurus) for dosage forms. Choosing the wrong one triggers a listing error.
Regulatory Pathway.
How is your drug legal? Is it an OTC Monograph drug? An approved New Drug (NDA)? A homeopathic? We identify the correct “Marketing Category” code for your submission.
Case
Carton
Bottle
Package Hierarchy.
SPL requires a nested view of your packaging. A bottle inside a carton inside a case. Each level needs its own NDC segment. We visualize this hierarchy for you.
Content of Labeling.
You must attach a high-res JPG of your label to the SPL. It must be legible, under 50KB size (historically), and true-to-color. We validate your image file before submission.
<id root='...'/>
<code code='34391-3'/>
<title>INDICATIONS</title>
<text>
<paragraph>For relief of...</paragraph>
</text>
</section>
The SPL Firewall.
FDA's gateway rejects submissions with even a single validation error. Our pre-submission engine runs 1,000+ checks (Schema, Vocabulary, Cardinality) to ensure acceptance.
Naming Rules.
The “Established Name” (generic) must be at least 50% the size of the “Proprietary Name” (brand). We check your label typography to prevent misbranding charges.
Route of Administration.
Is it Topical or Transdermal? Oral or Buccal? FDA defines these terms precisely. Selecting the wrong route code triggers a technical rejection.
DEA Scheduling.
If your drug contains a controlled substance (e.g., Codeine, Testosterone), the DEA Schedule (CII-CV) must be coded into the SPL and appear on the label.
The Facility Link.
Your drug listing must link to a valid, registered establishment via its DUNS number. If the facility registration expires, your drug listing becomes invalid. We monitor the link.
Repacker Logic.
Repacking bulk drugs into unit doses? You must reference the source NDC in your SPL. We handle the complex “Source NDC” mapping required for repackers.
Complex Kits.
Kits (Drug + Device, or Multiple Drugs) require a nested SPL structure. We generate the parent “Kit Listing” and link all inner components correctly.
TE Code Match.
For generic drugs, your Therapeutic Equivalence (TE) code must match the Orange Book. We verify your TE code assignment (e.g., AB, AP) against the RLD.
Color Safety.
Certain color additives (e.g., FD&C Yellow No. 5) require specific warning statements. We scan your inactive ingredients for restricted colorants.
Renewal Audit Trail.
FDA inspectors often ask for proof of past listings. Our platform maintains a permanent, immutable history of every annual certification you've filed.
Private Labeling.
If you are a Private Label Distributor (PLD), your listing is a “clone” of the manufacturer's listing. We handle the complex cross-referencing required to link your brand to their facility.
Live on DailyMed.
The goal: Your product appearing on DailyMed and in the NDC Directory. This is what buyers, hospitals, and Amazon check to verify your drug is real.
Platform vs. Coding XML.
You build the brand. We build the code.
List your drug in minutes.
Stop fighting with XML files. Launch your drug product today.
Listing Integrity
Ensuring your drug data remains accurate and compliant year-round.
Validation Rules
Running 1,000+ FDA validation rules before submission.
Renewal Alerts
Automated reminders for the Oct-Dec renewal window.
Change Control
Easy updates when you change suppliers or packaging.
Frequently Asked Questions
Common questions about this regulatory requirement.
Secure Your Supply Chain.
Don't let a clerical error stop your shipment at the border. Join 2,800+ food companies who trust Assurentry for automated compliance.