Last updated: July 27, 2025
Understanding the National Drug Code (NDC)
To analyze the market and price projections for a specific drug identified by its National Drug Code (NDC), it is crucial to understand what the NDC represents. The NDC is a unique, three-segment number that serves as a universal product identifier for human drugs in the United States. This code is used by the FDA to identify and track drug products, including prescription drugs, over-the-counter (OTC) drugs, and insulin products[1][4].
Identifying the Drug
The NDC 72819-0181 corresponds to a specific drug product. To identify this drug, one would need to refer to the FDA's National Drug Code Directory, which contains detailed information about finished drug products, unfinished drugs, and compounded drug products. This directory is updated daily and includes data submitted by drug establishments in structured product labeling (SPL) electronic listing files[4].
Market Context
Drug Price Trends
The pharmaceutical market is characterized by ongoing price increases, which pose significant challenges for patients, healthcare payers, and taxpayers. According to recent projections, drug price inflation is expected to grow at 3.8% in 2024, driven in part by specialty pharmaceuticals, including weight loss drugs and gene therapies[3].
Medicare Drug Price Negotiation Program
For drugs covered under Medicare, particularly those with significant price increases, the Medicare Drug Price Negotiation Program has been implemented to negotiate lower prices. For instance, in 2026, the first 10 negotiated prices are set to go into effect for Medicare Part D, with discounts ranging from 38% to 79% compared to list prices. This program aims to make prescription drugs more affordable for Medicare enrollees and taxpayers[2].
Price Projections
List Price Increases
Historical data shows that many drugs have experienced substantial list price increases over the years. For example, between 2018 and 2023, nine of the ten drugs selected for the first cycle of Medicare's negotiation program saw list price increases ranging from 20% to 55%[2].
Negotiated Prices
For the specific drug identified by NDC 72819-0181, if it is one of the drugs subject to Medicare's negotiation program or similar pricing initiatives, the negotiated prices could be significantly lower than the current list prices. Negotiated prices, or Maximum Fair Prices, are designed to reduce the financial burden on patients and healthcare systems[2].
Data Sources and Analysis
AnalySource and First DataBank
Data on drug prices, including list prices and market entry prices, can be obtained from databases like AnalySource, which reports prices at the NDC-11 level. This data is crucial for analyzing price trends and calculating average prices per 30-day equivalent supply. For the NDC 72819-0181, one would need to access these databases to obtain the specific pricing information and historical price changes[2].
Impact of Regulatory Changes
FDA Requirements and Compliance
Drug establishments must comply with FDA regulations, including updating their drug listing data in June and December of each year. Non-compliance can result in a drug product not being included in the NDC Directory. Ensuring that the drug product associated with NDC 72819-0181 is compliant with these regulations is essential for its continued market presence[1][4].
Key Considerations for Market Analysis
- Drug Category: Whether the drug is a prescription, OTC, or insulin product affects its inclusion in the NDC Directory and pricing regulations.
- Market Utilization: The volume of prescriptions and the conditions treated by the drug influence its market impact and pricing.
- Competitive Landscape: The presence of generic or biosimilar alternatives can impact the pricing strategy for the drug.
- Regulatory Environment: Changes in FDA regulations or pricing negotiation programs can significantly affect the drug's market price.
Example: Impact of Medicare Negotiations
For drugs like those selected for Medicare's negotiation program, the impact on pricing can be substantial. For instance:
"Nine of the 10 drugs selected for the first cycle of negotiation had list price increases ranging from 20% to 55% between 2018 and 2023. Comparing Medicare’s negotiated prices to list prices shows that negotiations resulted in discounts that range from a low of 38% to a high of 79%."[2]
Conclusion
The market analysis and price projections for a drug identified by its NDC, such as 72819-0181, involve a comprehensive review of historical price trends, regulatory compliance, and the impact of pricing negotiation programs. Here are the key takeaways:
Key Takeaways
- NDC Importance: The NDC is a critical identifier for tracking and regulating drug products.
- Price Trends: Drug prices, especially for specialty pharmaceuticals, are expected to continue rising, though negotiation programs can mitigate these increases.
- Regulatory Compliance: Ensuring compliance with FDA regulations is essential for maintaining market presence.
- Market Utilization: The volume of prescriptions and treated conditions significantly influence market impact and pricing.
- Competitive Landscape: The presence of generic or biosimilar alternatives can affect pricing strategies.
FAQs
What is the National Drug Code (NDC)?
The National Drug Code (NDC) is a unique, three-segment number that serves as a universal product identifier for human drugs in the United States.
Why are some drug products not included in the NDC Directory?
Drug products may not be included in the NDC Directory if they are not prescription, OTC, or insulin products, if the firm has notified the FDA that the product is no longer being marketed, or if the firm has not complied fully with its listing obligations.
How do Medicare negotiations affect drug prices?
Medicare negotiations can result in significant discounts, ranging from 38% to 79% compared to list prices, making prescription drugs more affordable for Medicare enrollees and taxpayers.
What data sources are used for analyzing drug prices?
Data sources such as AnalySource and First DataBank's MedKnowledge provide detailed pricing information, including list prices and market entry prices, which are essential for analyzing price trends.
How often must drug establishments update their listing data?
Drug establishments must update their drug listing data in June and December of each year to ensure compliance with FDA regulations.
What is the impact of specialty pharmaceuticals on drug price inflation?
Specialty pharmaceuticals, including weight loss drugs and gene therapies, are driving a projected 3.8% increase in drug price inflation, which is the highest since July 2019.