Understanding the National Drug Code (NDC)
To analyze the market and price projections for a specific drug identified by its NDC, it is crucial to understand what the NDC represents. The National Drug Code (NDC) is a unique, 10-digit, three-segment number that identifies a drug product. It consists of a labeler code, a product code, and a package code[1][4].
- Labeler Code: Assigned by the FDA, this segment identifies the firm that manufactures or distributes the drug.
- Product Code: Assigned by the firm, this segment identifies the specific strength, dosage form, and formulation of the drug.
- Package Code: Also assigned by the firm, this segment identifies the package sizes and types.
Identifying the Drug
The NDC 46122-0685 can be broken down as follows:
- Labeler Code: 46122
- Product Code: 068
- Package Code: 5
This NDC would correspond to a specific drug product, including its strength, dosage form, and packaging.
Market Analysis
Drug Pricing Trends
Drug prices in the U.S. market are subject to various factors, including inflation, regulatory changes, and market demand. For instance, the overall drug price inflation rate for 2025 is projected to be around 3.81% according to Vizient's summer Pharmacy Market Outlook for 2024[5].
Recent Price Changes
To understand the current market dynamics, looking at recent price changes for similar drugs can be insightful. For example, many prescription drugs have seen significant price increases between 2018 and 2023, ranging from 20% to 55%[2].
Negotiated Prices
The Medicare Drug Price Negotiation Program, set to begin in January 2026, will significantly impact the pricing of certain drugs. Negotiated prices under this program have resulted in discounts ranging from 38% to 79% compared to list prices[2].
Price Projections for NDC 46122-0685
Historical Pricing Data
While specific historical pricing data for NDC 46122-0685 is not provided here, analyzing trends from similar drugs can offer some insights. For example, the price of Triazolam (NDC 00054-4858) has fluctuated over the past year, with prices per unit ranging from $0.24415 to $0.42966[3].
Future Pricing Considerations
- Inflation: Given the projected drug price inflation rate of 3.81% for 2025, it is likely that the price of the drug identified by NDC 46122-0685 will increase accordingly[5].
- Regulatory Changes: If this drug is selected for negotiation under programs like the Medicare Drug Price Negotiation Program, its price could be significantly reduced.
- Market Demand: Changes in market demand, such as increased usage or competition from generic alternatives, can also influence price projections.
Impact of Regulatory Changes
Medicare Drug Price Negotiation Program
If the drug with NDC 46122-0685 is included in future cycles of the Medicare Drug Price Negotiation Program, its price could be substantially reduced. For instance, the first 10 drugs selected for negotiation saw discounts ranging from 38% to 79% compared to their list prices[2].
Conclusion
The market analysis and price projections for the drug identified by NDC 46122-0685 depend on several factors, including historical pricing trends, regulatory changes, and market demand. Here are some key points to consider:
- Historical Pricing: Analyze recent price changes for similar drugs to understand potential trends.
- Regulatory Impact: Consider the potential for inclusion in programs like the Medicare Drug Price Negotiation Program.
- Inflation and Demand: Account for projected inflation rates and changes in market demand.
Key Takeaways
- NDC Structure: Understand the components of the NDC to identify the drug, its strength, dosage form, and packaging.
- Pricing Trends: Be aware of recent price increases and projected inflation rates.
- Regulatory Changes: Consider the impact of programs like the Medicare Drug Price Negotiation Program.
- Market Demand: Monitor changes in market demand that could affect pricing.
FAQs
Q: What does the National Drug Code (NDC) represent?
A: The NDC is a unique, 10-digit, three-segment number that identifies a drug product, including the labeler, product, and package codes.
Q: How are NDCs assigned?
A: The FDA assigns the labeler code, while the firm assigns the product and package codes[1][4].
Q: What is the Medicare Drug Price Negotiation Program?
A: This program, starting in January 2026, involves negotiating prices for certain drugs under Medicare Part D to make them more affordable for Medicare enrollees[2].
Q: How do regulatory changes impact drug prices?
A: Regulatory changes, such as those under the Medicare Drug Price Negotiation Program, can significantly reduce drug prices through negotiated discounts[2].
Q: What factors influence drug price projections?
A: Factors include historical pricing trends, regulatory changes, market demand, and projected inflation rates[2][5].