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Clinical Trial Pipeline

The NDC directory covers drugs that are already approved and marketed. This section tracks what is still in testing — by therapeutic area, phase and how the treatment is given.

Phase 3 — closest to approval

Large comparative studies, typically 1–3 years from an FDA decision. This is where tomorrow's NDC codes come from.

Phase 2 — in development

Mid-size studies testing whether the treatment actually works for the condition, usually 3–5 years out.

Phase 1 — early research

First-in-human safety and dosing work. Long-term, but every approved drug started here.

Browse the pipeline by therapeutic area

Each area maps to the same pharmacologic classes used in the NDC directory, so you can move between an approved drug and what is coming next.

Clinical Trial Coding vs. Commercial Billing

How medical coding standardizes safety data in clinical research before drugs enter the NDC & J-Code directories.

Research Safety Standards

MedDRA & WHODrug

During clinical trials, adverse events (AEs) and medical conditions are standardized using the 5-tier MedDRA hierarchy. Concomitant medications are classified via the WHODrug global dictionary to monitor safety and drug-drug interactions for FDA/EMA submissions.

Post-Approval Commercial Coding

NDC, HCPCS & CPT Claims

Once a candidate proves safety and efficacy in Phase 3 trials and receives FDA approval (NDA/BLA), it transitions to commercial billing. The manufacturer lists the product for an 11-digit NDC, CMS assigns a permanent HCPCS J-Code, and payers reimburse claims via Box 24 line items.

Already approved? Look up the NDC

Once a treatment is marketed it gets a National Drug Code, a J-Code and a CPT administration code — all searchable in the directory.

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