Understanding the NDC: 00480-3683
The National Drug Code (NDC) 00480-3683 is associated with a drug product manufactured by Teva Pharmaceuticals, Inc. This specific NDC corresponds to a formulation of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate, commonly used in the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and narcolepsy[5].
Market Context
Drug Classification and Usage
The drug identified by NDC 00480-3683 is a central nervous system stimulant. It is prescribed for conditions such as ADHD and narcolepsy, which are chronic and require long-term management. This consistent demand can influence market stability and pricing.
Market Size and Growth
The ADHD and narcolepsy treatment markets are growing due to increasing diagnosis rates and a rising awareness of these conditions. According to industry reports, the global ADHD market is expected to grow significantly over the next few years, driven by the increasing prevalence of ADHD and the development of new treatments.
Pricing Dynamics
Current Pricing
The pricing of the drug with NDC 00480-3683 can vary based on several factors, including the dosage form, package size, and the specific product code. As of recent data, the prices for such stimulant medications can range widely depending on the pharmacy, location, and insurance coverage. For example, a 30-day supply of a similar formulation can cost anywhere from $50 to $200 or more, depending on the specific product and brand.
Price Projections
Given the growing demand for ADHD treatments and the stable market for central nervous system stimulants, it is likely that the prices for this drug will remain relatively stable or see moderate increases. Here are some key factors influencing price projections:
Demand and Supply Balance
The balance between demand and supply is crucial. If demand increases without a corresponding increase in supply, prices may rise. However, given the presence of multiple manufacturers and generic options, the market is generally competitive, which helps to stabilize prices.
Regulatory Environment
Regulatory changes, such as updates to the National Drug Code format or changes in FDA approval processes, can impact pricing. For instance, the FDA's proposed rule on revising the NDC format could potentially affect how drugs are listed and reported, but this is unlikely to have a direct impact on pricing in the short term[1].
Generic Competition
The presence of generic versions of this drug can significantly influence pricing. Generic drugs are typically cheaper than their brand-name counterparts, which can drive down prices across the market. Teva Pharmaceuticals, being a major generic drug manufacturer, plays a significant role in this dynamic.
Insurance and Reimbursement
Insurance coverage and reimbursement policies also play a critical role in pricing. Changes in insurance coverage or reimbursement rates can affect the out-of-pocket costs for patients and, consequently, the demand for the drug.
Market Analysis
Competitive Landscape
The market for ADHD treatments is highly competitive, with several major pharmaceutical companies, including Teva, Johnson & Johnson, and Shire (now part of Takeda), offering various products. This competition helps to keep prices in check.
Consumer Behavior
Consumer behavior, particularly in terms of adherence to medication and preference for brand-name versus generic drugs, can influence market dynamics. Patients often prefer generic options due to lower costs, which can shift market share towards generic manufacturers like Teva.
Economic Factors
Economic conditions, such as inflation and healthcare spending trends, can also impact drug pricing. In times of economic uncertainty, patients may be more inclined to opt for generic or cheaper alternatives, affecting the pricing strategy of pharmaceutical companies.
Key Takeaways
- Stable Demand: The chronic nature of ADHD and narcolepsy ensures a stable demand for treatments.
- Competitive Market: The presence of multiple manufacturers and generic options helps maintain competitive pricing.
- Regulatory Stability: Current regulatory environments are unlikely to significantly impact pricing in the short term.
- Insurance and Reimbursement: Changes in insurance coverage can affect out-of-pocket costs and demand.
- Generic Competition: Generic versions of the drug will continue to influence pricing dynamics.
FAQs
What is the NDC 00480-3683 used for?
The NDC 00480-3683 is used for a formulation of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate, commonly prescribed for ADHD and narcolepsy.
Who manufactures the drug with NDC 00480-3683?
The drug is manufactured by Teva Pharmaceuticals, Inc.
How does the FDA track and regulate drugs like NDC 00480-3683?
The FDA tracks and regulates drugs using the National Drug Code (NDC) system, which includes listing and reporting requirements for drug establishments. The NDC Directory contains information on all listed drugs, including their marketing start and end dates, and package sizes[1][3].
What factors influence the pricing of the drug with NDC 00480-3683?
Pricing is influenced by demand and supply balance, generic competition, regulatory environment, insurance and reimbursement policies, and economic factors.
Can I expect price increases for the drug with NDC 00480-3683?
Moderate price increases are possible due to growing demand and potential supply chain factors, but the competitive market and presence of generic options are likely to keep prices relatively stable.
Sources
- FDA's National Drug Code Directory: Contains information about finished drug products, unfinished drugs, and compounded drug products[1].
- CMS Drug Name and NDC Reference Data Instructions: Provides guidance on using the Drug Name and NDC Reference Data for reporting payments to the Open Payments system[2].
- National Drug Code Database Background Information - FDA: Explains the background and use of the National Drug Code (NDC) system[3].
- NDC 0074-3683 Kit Lupron Depot Drug Codes: Example of an NDC listing for a different drug product[4].
- Teva Pharmaceuticals, Inc. - List of Drugs - NDC Labeler/Manufacturer: Lists drugs manufactured by Teva Pharmaceuticals, including the one with NDC 00480-3683[5].
