Introduction
The National Drug Code (NDC) is a unique identifier for drugs in the United States, maintained by the U.S. Food and Drug Administration (FDA). This article will delve into the specifics of the NDC 49348-0981, including its components, market analysis, and price projections.
Components of the NDC 49348-0981
The NDC 49348-0981 is a 10-digit code divided into three segments:
- Labeler Code: The first segment, "49348," identifies the labeler or firm that manufactures, repackages, or distributes the drug[4].
- Product Code: The second segment, "098," identifies the specific strength, dosage form, and formulation of the drug for the particular firm[4].
- Package Code: The third segment, "1," identifies the package size and type[4].
Market Analysis
To analyze the market for the drug with NDC 49348-0981, we need to consider several factors:
Drug Classification and Usage
Understanding the drug's classification, such as its pharmacological class and Drug Enforcement Administration (DEA) schedule, is crucial. This information can be found in the FDA's NDC Directory, which includes data elements like the DEA schedule and pharmacological class[1].
Market Demand
The demand for the drug can be influenced by factors such as the prevalence of the condition it treats, the availability of alternative treatments, and the drug's efficacy and safety profile. For example, if the drug is used to treat a common condition, it may have higher demand and thus impact its pricing.
Competitive Landscape
Analyzing the competitive landscape involves identifying other drugs with similar indications and their market share. This can help in understanding the pricing dynamics and how the drug with NDC 49348-0981 fits into the market.
Regulatory Environment
Regulatory changes and compliance requirements can significantly impact the drug's market. For instance, changes in reimbursement policies or inclusion in programs like the Medicaid Drug Rebate Program (MDRP) can affect pricing and market access[2].
Price Projections
Ceiling Price Calculation
For drugs participating in the Medicaid Drug Rebate Program, the 340B ceiling price is calculated by subtracting the Unit Rebate Amount (URA) from the Average Manufacturer Price (AMP) for the smallest unit of measure, and then adjusting for package size and case pack size[2].
340B Ceiling Price = (AMP - URA) x PS x CSP
Historical Pricing Data
Reviewing historical pricing data from sources like the HRSA's 340B OPAIS or the FDA's NDC Directory can provide insights into price trends. This data includes the ceiling price by effective year and quarter, which can help in projecting future prices[2].
Market Forecast
Using market forecast scenarios, such as conservative, base, and optimistic scenarios, can help in accounting for future uncertainties. These scenarios consider various parameters like target consumer segments, adoption rates, and expected prices[3].
Example Analysis
Assuming the drug with NDC 49348-0981 is a covered outpatient drug under the MDRP, here is a simplified example of how its ceiling price might be calculated:
- Average Manufacturer Price (AMP): $10 per unit
- Unit Rebate Amount (URA): $2 per unit
- Package Size (PS): 10 units per package
- Case Pack Size (CSP): 5 packages per case
340B Ceiling Price = (10 - 2) x 10 x 5 = $400 per case
Key Takeaways
- NDC Components: The NDC 49348-0981 is composed of a labeler code, product code, and package code.
- Market Analysis: Understanding the drug's classification, market demand, competitive landscape, and regulatory environment is crucial for market analysis.
- Price Projections: Ceiling price calculations, historical pricing data, and market forecast scenarios are essential for projecting future prices.
- Regulatory Compliance: Compliance with programs like the MDRP and FDA regulations significantly impacts pricing and market access.
FAQs
-
What is the National Drug Code (NDC)?
- The NDC is a unique 10-digit identifier for drugs in the U.S., maintained by the FDA, which identifies the labeler, product, and package size[4].
-
How is the 340B ceiling price calculated?
- The 340B ceiling price is calculated by subtracting the URA from the AMP and then adjusting for package size and case pack size[2].
-
What information is included in the FDA's NDC Directory?
- The directory includes information such as the proprietary name, application number, labeler name, active ingredient, dosage form, route of administration, and marketing date[1].
-
Why is lyophilization important in drug formulation?
- Lyophilization is crucial for stabilizing biologic products that are not stable as liquid formulations, ensuring longer shelf life and maintaining efficacy[3].
-
How often is the FDA's NDC Directory updated?
- The FDA's NDC Directory is updated every day to include information on all listed drugs in their final marketed form[1].
Last updated: 2024-12-31
