What is an NDC?
Before diving into the market analysis and price projections for the drug with the NDC 00904-6195, it is crucial to understand what an NDC is. The National Drug Code (NDC) is a unique 10-digit, three-segment numerical code assigned to medications in the United States under Section 510 of the U.S. Federal Food, Drug and Cosmetic Act. This code identifies the labeler, the specific product, and the package size of the drug[1].
Structure of the NDC
The NDC is configured in a 5-4-2 format:
- Labeler Code: The first segment, assigned by the FDA, identifies the company that manufactures or distributes the drug.
- Product Code: The second segment identifies the specific strength, dosage form, and formulation of the drug.
- Package Code: The third segment identifies the package size and type[1].
Identifying the Drug
To analyze the market and project prices for the drug with NDC 00904-6195, we need to identify the drug name, its formulation, and the labeler.
Drug Name and Formulation
While the specific sources provided do not directly mention NDC 00904-6195, we can infer from similar NDC structures that this code would correspond to a specific drug product. For example, another NDC from the same labeler (e.g., 00904-5448) corresponds to "PENTOXIFYLLINE ER 400 MG TAB"[3].
Labeler
The labeler code "00904" is typically associated with a specific pharmaceutical company. For instance, the labeler code "00904" is linked to companies like Teva Pharmaceuticals or its subsidiaries, which are known for producing a wide range of generic and branded medications[4].
Market Analysis
Market Trends
The pharmaceutical market is subject to various trends and factors that influence drug prices. Here are some key points:
- General Market Growth: The overall prescription drug market is expected to grow at a CAGR of 9% through 2030, driven by increasing demand for healthcare services and advancements in pharmaceutical technology[5].
- Competition: Generic drugs, which often have multiple manufacturers, tend to have more competitive pricing compared to branded drugs. The presence of multiple manufacturers for a drug can drive prices down due to market competition.
- Regulatory Environment: Changes in regulatory policies, such as those related to drug approvals and pricing controls, can significantly impact the market dynamics and prices of drugs.
Pricing Factors
Drug prices are influenced by several factors, including:
- Production Costs: The cost of raw materials, manufacturing, and distribution.
- Market Demand: Higher demand can lead to higher prices, especially if supply is limited.
- Regulatory Approvals: The cost and time involved in obtaining regulatory approvals can impact pricing.
- Pricing Standards: NDC pricing is based on different pricing standards, such as Average Wholesale Price (AWP), Wholesale Acquisition Cost (WAC), and Average Sales Price (ASP)[1].
Price Projections
Historical Pricing Data
To project future prices, it is essential to analyze historical pricing data. For example, looking at similar drugs from the same labeler, such as PENTOXIFYLLINE ER 400 MG TAB (NDC 00904-5448), we can see fluctuations in price over time:
- Prices ranged from $0.26913 to $0.34441 per unit over the past year, indicating some volatility[3].
Forecasting Models
Using historical data and market trends, forecasting models can be employed to predict future prices. These models consider factors such as inflation, market growth, and changes in demand.
Example Forecast
Given the general market growth and assuming no significant changes in production costs or regulatory environment, here is a hypothetical forecast:
- Short-term Forecast: Prices for NDC 00904-6195 might remain stable or see a slight increase (around 2-5%) in the next quarter, aligning with the overall market growth.
- Long-term Forecast: Over the next year, prices could increase by around 5-7%, considering the expected CAGR of the prescription drug market.
Key Takeaways
- NDC Importance: Understanding the NDC is crucial for accurate billing, payment, and market analysis.
- Market Trends: The pharmaceutical market is growing, driven by increasing demand and technological advancements.
- Pricing Factors: Production costs, market demand, regulatory approvals, and pricing standards all influence drug prices.
- Forecasting: Historical data and market trends are essential for projecting future prices.
FAQs
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What does the NDC code represent?
- The NDC code is a unique 10-digit number that identifies the labeler, product, and package size of a drug[1].
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How are NDC codes structured?
- NDC codes are structured in a 5-4-2 format, with the first segment being the labeler code, the second segment being the product code, and the third segment being the package code[1].
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What factors influence drug prices?
- Drug prices are influenced by production costs, market demand, regulatory approvals, and different pricing standards[1].
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How can historical pricing data help in forecasting?
- Historical pricing data provides insights into price trends and volatility, which can be used to predict future prices using forecasting models.
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What is the expected growth rate of the prescription drug market?
- The prescription drug market is expected to grow at a CAGR of 9% through 2030[5].
Sources
- AAPC - NDC Code Lookup
- DrugPatentWatch - Latest drug prices and trends for NDC 50419-0459
- DrugPatentWatch - Latest pharmaceutical drug prices and trends for NDC 00904-5448
- FDA - National Drug Code Directory
- DrugPatentWatch - Latest drug prices and trends for NDC 00054-0319