Understanding the National Drug Code (NDC)
To analyze the market and price projections for a specific drug identified by its NDC number, such as 42291-0628, it is crucial to understand what the NDC represents. The National Drug Code (NDC) is a unique, three-segment number that serves as the FDA’s identifier for drugs. This code is used in the FDA's National Drug Code Directory, which contains information on active and certified finished and unfinished drugs submitted by labelers[1][5].
Breaking Down the NDC Number
The NDC number 42291-0628 can be broken down into three segments:
- Labeler Code: The first segment (42291) identifies the labeler, which could be a manufacturer, repackager, or relabeler.
- Product Code: The second segment (0628) identifies a specific strength, dosage form, and formulation for the particular firm.
- Package Code: The third segment identifies the package sizes and types.
Identifying the Drug
To identify the specific drug product associated with the NDC number 42291-0628, one would need to reference the FDA's NDC Directory. This directory provides detailed information on the drug, including its name, strength, dosage form, and packaging details[1][5].
Market Analysis
Overall Market Trends
For the period between January 1, 2025, and December 31, 2025, the Vizient Pharmacy Market Outlook projects a 0.00% overall drug price inflation rate. This suggests a stable pricing environment, but it does not account for individual drug price fluctuations[2].
Specific Drug Categories
- Generic and Brand Name Drugs: If the drug associated with NDC 42291-0628 is a generic, it might experience price increases similar to those reported in Oregon's transparency program, where the median price increase for generic drugs was 19.9% in 2022. For brand name drugs, the median price increase was 13.4%[2].
- Specialty Pharmaceuticals: If the drug falls under the specialty pharmaceutical category, it is likely to see a price increase in line with the overall trend of 3.8% to 5%[4].
Innovative Therapies
If the drug is part of a new therapeutic class, such as gene therapies or GLP-1 drugs, it may command higher prices due to its innovative nature and the value it brings to patients. The biopharma market, which includes such innovative therapies, is projected to grow significantly, with a compound annual growth rate (CAGR) of 7.56% between 2024 and 2029[3].
Price Projections
General Insights
Without specific data on the drug associated with NDC 42291-0628, it is challenging to provide precise price projections. However, here are some general insights:
- Stability in Pricing: Given the overall stable pricing environment projected for 2025, if the drug is well-established and not part of a highly innovative or specialty category, its price might remain relatively stable.
- Category-Specific Trends: If the drug is a generic, it could see a moderate price increase. If it is a brand name or specialty drug, it might experience higher price increases based on market trends.
Example Price Trends
For instance, looking at the price trends for another drug (NDC 72819-0160), we see fluctuations over time but generally stable prices with occasional increases:
- PALIPERIDONE ER 9 MG TABLET: Prices ranged from $1.44826 to $2.39324 per unit over different dates in 2024, indicating some volatility but overall stability[4].
Regulatory and Market Factors
Regulatory Landscape
The regulatory landscape is evolving to keep pace with innovation in the biopharma and biotech industries. Changes in clinical trial designs, such as accelerated and more efficient study designs, can impact drug development timelines and costs, which in turn can affect pricing[3].
Compounded Drug Products
If the drug associated with NDC 42291-0628 is a compounded drug product produced by an outsourcing facility, it may be exempt from certain approval requirements under Section 503B of the FD&C Act. However, these products must still be reported to the FDA and may be included in the NDC Directory if they have been assigned an NDC[1].
Conclusion
Key Takeaways
- NDC Understanding: The NDC is a critical identifier for drugs, broken down into labeler, product, and package codes.
- Market Stability: Overall drug price inflation is projected to be stable in 2025, but individual drugs can fluctuate based on category and innovation.
- Category-Specific Trends: Generic, brand name, and specialty drugs have different price increase trends.
- Regulatory Impact: Evolving regulatory landscapes and clinical trial designs can influence drug pricing and development.
FAQs
Q: What is the National Drug Code (NDC)?
A: The NDC is a unique, three-segment number that serves as the FDA’s identifier for drugs, identifying the labeler, product, and package size.
Q: How do I find the specific drug associated with an NDC number?
A: You can find the specific drug by referencing the FDA's NDC Directory, which contains detailed information on the drug.
Q: What are the overall market trends for drug prices in 2025?
A: The overall drug price inflation rate is projected to be 0.00% for 2025, indicating a stable pricing environment.
Q: How do generic and brand name drugs differ in terms of price increases?
A: Generic drugs might see higher price increases (e.g., 19.9% in 2022) compared to brand name drugs (e.g., 13.4% in 2022).
Q: What impact do innovative therapies have on drug pricing?
A: Innovative therapies, such as gene therapies or GLP-1 drugs, can command higher prices due to their innovative nature and the value they bring to patients.
Sources
- FDA - National Drug Code Directory
- DrugPatentWatch - Latest pharmaceutical drug prices and trends for NDC 42291-0779
- TFS CRO - 5 Predictions for the Biopharma and Biotech Industries in 2025
- DrugPatentWatch - Latest drug prices and trends for NDC 72819-0160
- FDA - National Drug Code Database Background Information
