Overview of NDC 51672-4219
The National Drug Code (NDC) 51672-4219 corresponds to Doxepin Hydrochloride, a medication manufactured and distributed by Taro Pharmaceuticals U.S.A., Inc. This drug is listed in the FDA's National Drug Code Directory, which provides comprehensive information on all drugs manufactured, prepared, propagated, compounded, or processed for sale in the U.S.[1].
Drug Description and Uses
Doxepin Hydrochloride is an antidepressant and an antihistamine, commonly used to treat depression, anxiety, and certain types of sleep disorders. It belongs to the class of tricyclic antidepressants and works by affecting the balance of certain natural chemicals (neurotransmitters) in the brain.
Market Context
To analyze the market and price projections for Doxepin Hydrochloride (NDC 51672-4219), it is essential to consider the broader pharmaceutical market trends and the specific dynamics of the antidepressant and antihistamine markets.
Pharmaceutical Industry Trends
The pharmaceutical industry is undergoing significant changes driven by advancements in technology, regulatory shifts, and evolving patient needs. Artificial intelligence (AI) and gene editing technologies are accelerating drug development, reducing costs, and enhancing efficiency. These trends are expected to continue shaping the industry in 2025 and beyond[3].
Antidepressant Market
The antidepressant market is a segment of the larger psychiatric drugs market. This market is influenced by factors such as the prevalence of mental health disorders, the availability of new treatments, and the impact of generic drugs on branded products.
Price Projections
While specific price projections for NDC 51672-4219 are not readily available, we can infer some insights from general pricing trends in the pharmaceutical industry.
Pricing Trends
Prices for generic drugs like Doxepin Hydrochloride can fluctuate based on several factors, including market competition, production costs, and regulatory changes. Here are some key points to consider:
- Generic Competition: The presence of generic versions of Doxepin Hydrochloride can drive prices down. Generic drugs often enter the market after the patent expiration of the branded version, leading to increased competition and lower prices[4].
- Production Costs: Changes in raw material costs, manufacturing processes, and other production-related factors can influence the pricing of the drug.
- Regulatory Environment: Regulatory changes, such as those related to drug safety and efficacy, can impact pricing strategies.
Historical Pricing Data
For a similar drug, Dapsone 5% Gel (NDC 51672-1387), historical pricing data shows variations over time. For example, the price per unit for Dapsone 5% Gel has fluctuated between $1.37 and $1.87 per gram over different periods in 2024[2].
Projected Market Dynamics
Given the generic nature of Doxepin Hydrochloride, here are some projected market dynamics:
- Stable Demand: The demand for antidepressants and antihistamines is generally stable due to the ongoing need for these medications.
- Price Stability: Prices for generic drugs tend to be stable or decrease over time due to competition. However, any significant changes in production costs or regulatory requirements could impact pricing.
- Market Share: Taro Pharmaceuticals, as a manufacturer, will need to compete with other generic and branded versions of Doxepin Hydrochloride to maintain market share.
Key Takeaways
- Regulatory Compliance: The drug must comply with FDA regulations, including listing in the NDC Directory and adherence to manufacturing standards.
- Market Competition: The presence of generic competitors will likely keep prices stable or decreasing.
- Technological Advancements: While AI and other technologies are transforming drug development, their direct impact on the pricing of established generic drugs like Doxepin Hydrochloride may be minimal.
- Patient Needs: The ongoing need for effective treatments for depression and anxiety will continue to drive demand for Doxepin Hydrochloride.
FAQs
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What is the National Drug Code (NDC) for Doxepin Hydrochloride?
- The NDC for Doxepin Hydrochloride manufactured by Taro Pharmaceuticals U.S.A., Inc. is 51672-4219.
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What is Doxepin Hydrochloride used for?
- Doxepin Hydrochloride is used to treat depression, anxiety, and certain sleep disorders.
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How does the FDA regulate drugs like Doxepin Hydrochloride?
- The FDA requires drug establishments to provide a current list of all drugs manufactured, prepared, propagated, compounded, or processed for sale in the U.S. and lists them in the NDC Directory[1].
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What factors influence the price of generic drugs like Doxepin Hydrochloride?
- Factors include market competition, production costs, and regulatory changes.
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How are technological advancements impacting the pharmaceutical industry?
- AI and gene editing technologies are accelerating drug development, reducing costs, and enhancing efficiency, though their direct impact on established generic drugs may be minimal[3].
Sources
- FDA National Drug Code Directory - FDA
- Latest drug prices and trends for NDC 51672-1387 - DrugPatentWatch
- The Future of Pharma: 2025's Key Trends To Know - Laboratorios Rubio
- NSCLC MARKET - Global Drug Forecast & Market Analysis to 2025 - Drug Development
- Taro Pharmaceuticals U.S.A. Inc. - List of Drugs - NDC Labeler - FindACode
