Understanding the NDC Code
To begin with, it's crucial to understand what the National Drug Code (NDC) represents. The NDC is a unique, 10-digit, three-segment number that identifies a drug product. For the NDC 52536-0510, here is the breakdown:
- Labeler Code: 52536, assigned by the FDA to the labeler, in this case, Wilshire Pharmaceuticals, Inc.
- Product Code: 0510, which identifies the specific strength, dosage form, and formulation of the drug.
- Package Code: This segment identifies the package size and type[1].
Drug Identification
The NDC 52536-0510 corresponds to Dextroamphetamine Sulfate tablets. Here are some key details about this drug:
- Drug Name: Dextroamphetamine Sulfate
- Category: Human Prescription Drug
- DEA Schedule: CII, indicating a high potential for abuse and misuse[4].
Market Trends and Price Projections
Current Market Context
The pharmaceutical market is experiencing significant changes, particularly with the rise of specialty pharmaceuticals. According to Vizient, Inc., drug price inflation is projected to grow at 3.8% in 2024, driven largely by specialty pharmacy, including weight loss drugs and gene therapies[2].
Price Analysis for NDC 52536-0510
While the provided sources do not specifically mention the price trends for NDC 52536-0510, we can infer some insights from related data:
- General Price Trends: The overall pharmaceutical market is seeing an increase in prices, especially for specialty drugs. However, the prices for generic or non-specialty drugs like Dextroamphetamine Sulfate might not follow the same steep increase.
- Historical Pricing Data: For a similar NDC (52536-0104), which corresponds to Vancomycin 25 MG/ML Oral Solution, prices have shown a fluctuating trend. For example, the price per unit for Vancomycin has ranged from $0.48102 to $0.67306 per ML over the past year. This indicates that prices can vary based on market conditions, supply chain factors, and demand[5].
Projected Price Trends for Dextroamphetamine Sulfate
Given the current market context and historical pricing data for similar drugs:
- Stable Pricing: Dextroamphetamine Sulfate, being a non-specialty drug, might experience more stable pricing compared to specialty pharmaceuticals. However, it could still be subject to minor fluctuations based on market conditions.
- Inflation Impact: The overall 3.8% projected increase in drug prices might have a minimal impact on the pricing of Dextroamphetamine Sulfate, as it is not classified as a specialty drug.
Supply Chain and Demand Factors
- Supply Chain Stability: The stability of the supply chain can significantly impact drug prices. Any disruptions or shortages could lead to price increases.
- Demand: The demand for Dextroamphetamine Sulfate, which is used to treat conditions like ADHD and narcolepsy, is relatively consistent. This consistent demand can help stabilize prices.
Regulatory and Market Dynamics
- Regulatory Changes: Changes in regulatory policies or FDA guidelines can affect drug pricing. For instance, any changes in the approval process or labeling requirements could impact production costs and subsequently prices.
- Market Competition: The presence of generic versions of Dextroamphetamine Sulfate can keep prices competitive. However, the market share of these generics and their pricing strategies will influence the overall price trend.
Expert Insights
Industry experts like Carina Dolan from Vizient, Inc., emphasize the importance of managing pharmacy expenditures and strengthening the supply chain, especially in the face of rising drug costs and drug shortages. While these insights are more relevant to specialty pharmaceuticals, they highlight the broader challenges and considerations in the pharmaceutical market[2].
Key Takeaways
- NDC Code: The NDC 52536-0510 identifies Dextroamphetamine Sulfate tablets, with the labeler code, product code, and package code providing specific details about the drug.
- Market Trends: The pharmaceutical market is experiencing a 3.8% price increase driven by specialty drugs, but non-specialty drugs like Dextroamphetamine Sulfate may see more stable pricing.
- Price Projections: Prices for Dextroamphetamine Sulfate are likely to remain relatively stable, with minor fluctuations based on market conditions and supply chain factors.
- Regulatory and Market Dynamics: Regulatory changes, supply chain stability, and market competition will influence the pricing of Dextroamphetamine Sulfate.
FAQs
Q: What does the NDC code 52536-0510 represent?
A: The NDC code 52536-0510 represents Dextroamphetamine Sulfate tablets, including the labeler, product, and package details.
Q: How are drug prices expected to change in 2024?
A: According to Vizient, Inc., drug prices are projected to increase by 3.8% in 2024, driven by specialty pharmaceuticals.
Q: What factors influence the pricing of Dextroamphetamine Sulfate?
A: Factors such as supply chain stability, demand, regulatory changes, and market competition influence the pricing of Dextroamphetamine Sulfate.
Q: Is Dextroamphetamine Sulfate considered a specialty drug?
A: No, Dextroamphetamine Sulfate is not classified as a specialty drug; it is used to treat conditions like ADHD and narcolepsy.
Q: How does the FDA regulate drug pricing and labeling?
A: The FDA regulates drug labeling and requires drug establishments to provide detailed information, including NDC codes, but does not directly regulate drug pricing. Pricing is influenced by market dynamics and other factors.
Sources
- National Drug Code Database Background Information - FDA
- Vizient Projects 3.8% Drug Price Increase Driven by Specialty Pharmaceuticals
- Antimicrobial Drugs Market Returns Analysis
- Label: DEXTROAMPHETAMINE SULFATE tablet - DailyMed
- Latest drug prices and trends for NDC 52536-0104 - DrugPatentWatch