Understanding the National Drug Code (NDC)
The National Drug Code (NDC) is a unique, three-segment number that identifies a drug product. It is a crucial component in the pharmaceutical industry, helping to track and manage drug products efficiently. The NDC for the drug in question is 61874-0145.
Breakdown of the NDC
- Labeler Code: The first segment of the NDC, which is assigned by the FDA, identifies the labeler or the firm that manufactures, repackages, or relabels the drug. For NDC 61874-0145, "61874" would be the labeler code.
- Product Code: The second segment identifies the specific strength, dosage form, and formulation of the drug. This code is assigned by the firm.
- Package Code: The third segment identifies the package size and type. This code is also assigned by the firm[4].
Market Analysis
Current Market Trends
The pharmaceutical market is experiencing significant changes, particularly in the areas of specialty and gene therapies. According to Vizient's Pharmacy Market Outlook, drug price inflation is projected to grow at 3.8% in 2025, driven largely by specialty pharmaceuticals and the increasing utilization of high-cost therapies such as gene and cell therapies[2][3].
Drug Price Inflation
The overall drug price inflation rate is expected to be around 3.8%, with specialty pharmaceuticals contributing significantly to this increase. This trend is influenced by the expanding indications of previously approved medications and the introduction of new, high-cost therapies. For example, GLP-1 agents like semaglutide have seen a 77% increase in spend due to their expanded indications for treating diabetes, obesity, and cardiovascular diseases[2].
Impact of Gene and Cell Therapies
Gene and cell therapies, such as CAR-T therapies for blood cancers, are becoming more prevalent and expensive. These therapies can range from $250,000 to $4.25 million per dose, significantly impacting provider budgets and operational processes[2].
Price Projections for NDC 61874-0145
Historical Pricing Data
To project future prices for the drug with NDC 61874-0145, it is essential to analyze historical pricing data. However, specific pricing data for this NDC is not provided in the sources. Generally, drug prices can fluctuate based on various factors such as production costs, market demand, regulatory changes, and competition.
General Pricing Trends
Given the broader market trends, here are some general insights:
- Specialty Pharmaceuticals: If the drug falls under the category of specialty pharmaceuticals, it is likely to experience a price increase in line with the projected 4.18% for specialty medications[3].
- Biosimilars and Generics: If there are biosimilar or generic versions of the drug, they might influence pricing by offering more affordable alternatives. However, biosimilars are expected to increase in price by only 0.55%, which is relatively minimal[3].
Potential Price Increases
Without specific historical data for NDC 61874-0145, we can infer potential price increases based on general trends:
- Average Increase: A drug in this category might see a price increase in the range of 3-4%, aligning with the overall projected inflation rate for pharmaceuticals.
- High-Cost Therapies: If the drug is a high-cost therapy, such as a gene or cell therapy, the price increase could be more significant, potentially exceeding the average inflation rate.
Regulatory and Listing Considerations
FDA Listings and Updates
The FDA's National Drug Code Directory includes information on active and certified finished and unfinished drugs. Drug establishments must update their drug listing data in June and December each year to reflect any changes or new listings[1][4].
Compliance and Errors
Ensuring that the drug is listed correctly in the NDC Directory is crucial. Any errors or discrepancies must be reported to the FDA to maintain the integrity of the database[4].
Key Takeaways
- Market Trends: The pharmaceutical market is experiencing a 3.8% price inflation rate driven by specialty and gene therapies.
- Pricing Projections: Without specific data, the drug with NDC 61874-0145 is likely to see a price increase in the range of 3-4%, depending on its category and market conditions.
- Regulatory Compliance: Ensuring accurate and up-to-date listings in the NDC Directory is essential for regulatory compliance.
FAQs
What is the National Drug Code (NDC)?
The National Drug Code (NDC) is a unique, three-segment number that identifies a drug product, including the labeler, product, and package size.
How is the NDC used in the pharmaceutical industry?
The NDC is used to track and manage drug products efficiently. It is essential for regulatory compliance, inventory management, and billing purposes.
What factors influence drug price inflation?
Drug price inflation is influenced by factors such as expanding indications of previously approved medications, the introduction of new high-cost therapies, production costs, market demand, and regulatory changes.
How often must drug establishments update their listing data?
Drug establishments must update their drug listing data in June and December each year to reflect any changes or new listings[1][4].
What happens if a drug product is not listed in the NDC Directory?
A drug product may not appear in the NDC Directory if it is not a prescription, OTC, or insulin product, if the firm has notified the FDA that the product is no longer being marketed, or if the firm has not complied fully with its listing obligations[4].
Sources
- FDA's National Drug Code Directory - FDA
- Vizient Projects Drug Price Inflation at 3.81% - Vizient, Inc.
- Vizient Projects 3.8% Drug Price Increase Driven by Specialty Pharmaceuticals - Vizient, Inc.
- National Drug Code Database Background Information - FDA
- Latest Drug Prices and Trends for NDC 50419-0453 - DrugPatentWatch
