Understanding the National Drug Code (NDC)
The National Drug Code (NDC) is a unique 10- or 11-digit number assigned to each medication by the FDA. It is crucial for identifying, tracking, and managing pharmaceutical products throughout the supply chain, from manufacturing to patient dispensing. The NDC 58151-0156, like other NDCs, is composed of three segments: the labeler code, product code, and package code[1].
Drug Details and Labeler Information
To analyze the market and price projections for the drug with NDC 58151-0156, it is essential to understand the specific drug details and the labeler.
- Proprietary Name and Ingredients: The proprietary name and ingredients of the drug can be found through FDA databases or pharmaceutical directories. However, specific details for NDC 58151-0156 are not provided in the sources, so one would need to consult the FDA's DailyMed database or similar resources.
- Labeler and Distributor: The labeler code "58151" identifies the company responsible for labeling and distributing the drug. This information can help in understanding the market presence and pricing strategies of the labeler[4].
Market Trends and Price Inflation
Overall Pharmaceutical Market
The pharmaceutical market is experiencing significant changes and challenges, including rising prices and the introduction of new, high-cost therapies.
- Drug Price Inflation: According to Vizient's Pharmacy Market Outlook, the overall drug price inflation rate for pharmaceuticals in 2025 is projected to be 3.81%. This inflation is driven by factors such as expanding indications for previously approved medications and the introduction of high-cost cell and gene therapies[2].
- Global Price Comparisons: The U.S. pharmaceutical market is characterized by higher prices compared to other regions. Prices in the U.S. are 5.5 times higher than in the OECD (excluding the U.S.) and 7.7 times higher than in the rest of the world. This disparity is due to both higher prices for the same drugs and a drug mix that skews towards more expensive compounds[3].
Specific Drug Price Analysis
For a detailed analysis of the drug with NDC 58151-0156, one would typically look at historical price data, market demand, and competitive landscape.
- Historical Price Data: Historical price data can be obtained from databases such as DrugPatentWatch or FDA.report. This data helps in identifying trends and fluctuations in the drug's price over time. For example, prices for other drugs have shown significant variability, with some experiencing increases due to changes in market conditions or new indications[5].
- Market Demand and Competition: The demand for the drug and the level of competition in its therapeutic class can significantly impact its price. Drugs with expanding indications, like semaglutide, have seen substantial increases in spend due to broader usage[2].
Impact of NDC Changes
The FDA's impending change to the NDC format, necessitated by the depletion of 5-digit labeler codes, will have far-reaching implications for the pharmaceutical industry.
- Systemic Impact: The transition from a 5-digit to a 6-digit labeler code will affect nearly every system involved in pharmaceutical product manufacturing, distribution, and pharmacy operations. This change could be as significant as the Y2K preparations and will require extensive updates to IT systems, business processes, and clinical practices[1].
- Operational and Economic Impacts: The change will involve substantial investments in IT infrastructure, training, and compliance. It may also affect the pricing and reimbursement processes, potentially influencing the market dynamics of drugs like the one with NDC 58151-0156.
Price Projections
Given the current market trends and the anticipated changes in the pharmaceutical landscape, here are some considerations for price projections:
- Inflation and Market Growth: With an overall drug price inflation rate of 3.81% projected for 2025, it is likely that the price of the drug with NDC 58151-0156 will also increase, although the exact rate will depend on specific market factors.
- Competition and Demand: The price will be influenced by the drug's market position, competition within its therapeutic class, and any changes in demand due to new indications or clinical guidelines.
- Regulatory and Systemic Changes: The impact of the NDC format change on pricing will be indirect but significant, as it may lead to increased costs for manufacturers and distributors, which could be passed on to consumers.
Key Takeaways
- NDC Importance: The NDC is a critical identifier in the pharmaceutical supply chain, and changes to its format will have widespread impacts.
- Market Trends: The pharmaceutical market is characterized by rising prices, driven by inflation, new therapies, and global price disparities.
- Price Projections: Prices for specific drugs like NDC 58151-0156 will be influenced by overall market trends, competition, and systemic changes.
FAQs
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What is the National Drug Code (NDC)?
- The NDC is a unique 10- or 11-digit number assigned to each medication by the FDA, used for identifying and tracking pharmaceutical products.
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Why is the FDA changing the NDC format?
- The FDA is changing the NDC format because it is running out of 5-digit labeler codes due to the increasing number of new labelers entering the U.S. market.
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How will the NDC format change affect the pharmaceutical industry?
- The change will impact nearly every system involved in pharmaceutical product manufacturing, distribution, and pharmacy operations, requiring significant updates to IT systems, business processes, and clinical practices.
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What are the key drivers of drug price inflation in 2025?
- The key drivers include expanding indications for previously approved medications and the introduction of high-cost cell and gene therapies.
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How do U.S. drug prices compare to global prices?
- U.S. drug prices are significantly higher than those in other regions, being 5.5 times higher than in the OECD (excluding the U.S.) and 7.7 times higher than in the rest of the world.
Sources
- Wolters Kluwer: "Are You Prepared for a Major Industry Change to the National Drug Code (NDC) Number?"
- Vizient Inc.: "Vizient projects drug price inflation at 3.81%"
- ASPE: "ISSUE BRIEF - International Market Size and Prices"
- FDA.report: "NDC 58151-155"
- DrugPatentWatch: "Latest drug prices and trends for NDC 51672-1387"
