Last updated: July 27, 2025
Understanding the National Drug Code (NDC)
To analyze the market and price projections for a drug identified by the National Drug Code (NDC) 00904-4040, it is crucial to first understand what the NDC represents. The NDC is a unique, three-segment number that identifies a drug product. It consists of a labeler code, a product code, and a package code. The labeler code is assigned by the FDA and identifies the firm that manufactures, repackages, or distributes the drug. The product code and package code are assigned by the firm and identify the specific strength, dosage form, and formulation of the drug, as well as the package sizes and types, respectively[1].
Identifying the Drug
The NDC 00904-4040 would correspond to a specific drug product. Here is a breakdown of what each segment might represent:
- Labeler Code: The first segment (00904) identifies the labeler or the firm responsible for 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.
Market Analysis
Drug Pricing Trends
To analyze the market for the drug with NDC 00904-4040, one must look at historical pricing data and trends. Drug prices can fluctuate based on various factors such as production costs, market demand, regulatory changes, and competition.
For example, if we consider another NDC (00904-7014) for a different drug, we see that prices can vary over time and by package size. Prices for Child Acetaminophen 160 MG/5 ML under NDC 00904-7014 have shown minor fluctuations, indicating a relatively stable market for this particular drug[2].
Regulatory Impact
Regulatory changes can significantly impact drug pricing and market dynamics. Programs like the 340B Drug Pricing Program, which requires drug companies to offer discounted prices to eligible hospitals, can influence the overall pricing strategy for drugs. However, these discounts constitute a small share of drug company revenues and do not drastically alter the market prices for most drugs[4].
Price Projections
Factors Influencing Price Projections
Several factors can influence price projections for a drug:
- Production Costs: Changes in raw material costs, manufacturing processes, and labor can affect the final price of the drug.
- Market Demand: Increased demand, especially for essential or life-saving drugs, can drive up prices.
- Regulatory Changes: New regulations or changes in existing programs like the 340B program can impact pricing.
- Competition: The presence of generic or biosimilar alternatives can reduce prices.
- Technological Advancements: Innovations in drug development and manufacturing can lead to more efficient production and potentially lower costs[3].
Predictive Models
To make accurate price projections, pharmaceutical companies and analysts often use predictive models that account for these factors. These models can include historical pricing data, market trends, and forecasts of future demand and regulatory changes.
Example of Price Fluctuations
While specific data for NDC 00904-4040 is not provided, we can look at similar drugs for insights. For instance, the prices for Child Acetaminophen 160 MG/5 ML (NDC 00904-7014) have shown minor fluctuations over recent months, ranging from $0.00835 to $0.02053 per milliliter. This stability suggests that, absent significant changes in the market or regulatory environment, prices for similar drugs might remain relatively stable[2].
Future Trends in the Biopharma and Biotech Industries
The biopharma and biotech industries are expected to undergo significant changes in 2025, driven by advancements in clinical trial designs, regulatory frameworks, and technological innovations. These trends could impact drug pricing and market dynamics:
- Accelerated Clinical Trial Designs: More efficient clinical trials could reduce development costs and potentially lower drug prices[3].
- Precision Medicine: Personalized treatments might increase costs in the short term but could lead to better patient outcomes and more targeted therapies[3].
- Regulatory Evolution: Changes in regulatory frameworks could influence the approval process and pricing strategies for new drugs[3].
Key Takeaways
- NDC Understanding: The NDC is crucial for identifying and tracking drug products.
- Market Analysis: Historical pricing data and trends are essential for market analysis.
- Regulatory Impact: Programs like the 340B program can influence pricing but constitute a small share of drug company revenues.
- Price Projections: Predictive models considering production costs, market demand, regulatory changes, competition, and technological advancements are vital.
- Future Trends: Advancements in clinical trials, precision medicine, and regulatory frameworks will shape the future of drug pricing and market dynamics.
FAQs
Q: What does the National Drug Code (NDC) represent?
A: The NDC is a unique, three-segment number that identifies a drug product, including the labeler, product, and package code.
Q: How do regulatory programs like the 340B program affect drug pricing?
A: These programs require drug companies to offer discounted prices to eligible hospitals, but these discounts constitute a small share of drug company revenues and do not drastically alter market prices.
Q: What factors influence price projections for drugs?
A: Factors include production costs, market demand, regulatory changes, competition, and technological advancements.
Q: How are price projections for drugs typically made?
A: Predictive models that account for historical pricing data, market trends, and forecasts of future demand and regulatory changes are used.
Q: What are some future trends expected to impact the biopharma and biotech industries?
A: Trends include accelerated clinical trial designs, evolving regulatory frameworks, and the rise of precision medicine and AI/ML technologies.
Sources
- FDA - National Drug Code Database Background Information
- DrugPatentWatch - Latest pharmaceutical drug prices and trends for NDC 00904-7014
- TFS CRO - 5 Predictions for the Biopharma and Biotech Industries in 2025
- AHA - The 340B Drug Pricing Program
- FDA - National Drug Code Directory
