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. This code is crucial for identifying and reporting drug products to the FDA and is used in the Drug Registration and Listing System (DRLS) and its electronic counterpart, eDRLS[1][4].
Structure of the NDC
The NDC consists of three segments: the labeler code, the product code, and the package code. The labeler code, assigned by the FDA, identifies the firm that manufactures, repackages, or relabels the drug. The product code, assigned by the firm, identifies the specific strength, dosage form, and formulation of the drug. The package code identifies the package sizes and types. The configuration of the NDC can be 4-4-2, 5-3-2, or 5-4-1 digits[1].
Market Analysis for NDC 65862-0865
To conduct a market analysis for a specific NDC, such as 65862-0865, several factors need to be considered:
Drug Identification
First, identify the drug associated with the NDC 65862-0865. This involves checking the FDA's National Drug Code Directory, which contains information on active and certified finished and unfinished drugs, including prescription and over-the-counter drugs[4].
Market Demand
Understand the demand for the drug by analyzing patient populations, disease prevalence, and treatment guidelines. For example, if the drug is used to treat a common condition like diabetes or cardiovascular disease, it is likely to have a significant market demand[2].
Competitive Landscape
Analyze the competitive landscape by identifying other drugs in the same therapeutic class and their market share. This includes looking at brand-name drugs, generics, and biosimilars that may compete with the drug in question[3].
Price Trends
Examine historical price trends for the drug. High prescription drug prices, especially those with significant increases over time, can impact affordability and market dynamics. For instance, drugs selected for Medicare price negotiation have seen substantial price increases, ranging from 20% to 55% between 2018 and 2023[2].
Price Projections for NDC 65862-0865
Historical Pricing Data
Review the historical pricing data for the drug. If the drug has experienced significant price increases in the past, it may continue to do so unless regulatory or market changes intervene. For example, some drugs have seen extraordinary price increases, such as those over 100% or even 1,000% in certain cases[3].
Regulatory Impact
Consider the impact of regulatory changes, such as the Medicare Drug Price Negotiation Program. Beginning in January 2026, negotiated prices for certain drugs will go into effect, resulting in discounts ranging from 38% to 79% compared to list prices. If the drug associated with NDC 65862-0865 is selected for such negotiations, its price could significantly decrease[2][5].
Market Forces
Evaluate market forces such as supply and demand, competition, and economic conditions. Factors like unusual dosage forms, limited distribution channels, and intellectual property rights can influence drug prices. For instance, orphan drugs and drugs with limited competition often see higher price increases[3].
Example: Impact of Medicare Negotiations
If the drug associated with NDC 65862-0865 is selected for Medicare price negotiation, the price could drop substantially. For example, drugs like Januvia and Farxiga, used to treat diabetes, saw negotiated prices that were 79% and 68% lower than their list prices, respectively[5].
Key Takeaways
- NDC Importance: The NDC is crucial for identifying and tracking drug products.
- Market Demand: Understanding the patient population and treatment guidelines is essential for market analysis.
- Competitive Landscape: Analyzing competing drugs helps in predicting market share.
- Price Trends: Historical price data and regulatory changes significantly impact price projections.
- Regulatory Changes: Programs like Medicare price negotiation can drastically reduce drug prices.
FAQs
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What is the National Drug Code (NDC)?
- The NDC is a unique, three-segment number that identifies human drugs in the United States.
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How is the NDC structured?
- The NDC consists of a labeler code, product code, and package code, configured as 4-4-2, 5-3-2, or 5-4-1 digits.
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Why are some drugs not included in the NDC Directory?
- Drugs may not be included if they are not prescription, OTC, or insulin products, or if the firm has not complied with listing obligations.
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How do regulatory changes impact drug prices?
- Regulatory changes, such as Medicare price negotiations, can significantly reduce drug prices by negotiating lower prices.
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What factors drive extraordinary price increases in drugs?
- Factors include unusual dosage forms, limited distribution channels, intellectual property rights, and the status of orphan drugs.
Sources
- FDA - National Drug Code Database Background Information
- ASPE - Medicare Drug Price Negotiation Program
- SP Global - New Study Indicates "Extraordinary" Price Rises in 17 Drugs in U.S.
- FDA - National Drug Code Directory
- White House - Fact Sheet: Biden-Harris Administration Announces New, Lower Prices for First Ten Drugs Selected for Medicare Price Negotiation
