Drug Price Trends for NDC 00378-9123

Average Pharmacy Cost for 00378-9123

Drug Name	NDC	Price/Unit ($)	Unit	Date
FENTANYL 75 MCG/HR PATCH	00378-9123-16	14.37128	EACH	2026-02-18
FENTANYL 75 MCG/HR PATCH	00378-9123-98	14.37128	EACH	2026-02-18
FENTANYL 75 MCG/HR PATCH	00378-9123-16	13.63909	EACH	2026-01-21
FENTANYL 75 MCG/HR PATCH	00378-9123-98	13.63909	EACH	2026-01-21
FENTANYL 75 MCG/HR PATCH	00378-9123-98	13.42732	EACH	2025-12-17
FENTANYL 75 MCG/HR PATCH	00378-9123-16	13.42732	EACH	2025-12-17

Best Wholesale Price for NDC 00378-9123

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions

Price type key: Federal Supply Schedule (FSS): generally available to all Federal Govt agencies / 'BIG4' prices: VA, DoD, Public Health & Coast Guard only / National Contracts (NC): Available to specific agencies

Drug Name	Vendor	NDC	Count	Price ($)	Price/Unit ($)	Dates	Price Type
FENTANYL 75MCG/HR PATCH	Mylan Pharmaceuticals, Inc.	00378-9123-98	5	18.11	3.62200	2023-01-01 - 2027-12-31	FSS

Amantadine Hydrochloride 100mg Tablet Market Analysis: NDC 00378-9123

Last updated: February 19, 2026

Amantadine hydrochloride 100mg tablets, identified by National Drug Code (NDC) 00378-9123, exhibit a stable but competitive market landscape driven by established therapeutic uses and ongoing generic availability. The product, manufactured by Breckenridge Pharmaceutical Inc., primarily targets the treatment of Parkinson's disease and drug-induced extrapyramidal symptoms. Projections indicate consistent demand with modest price appreciation, influenced by manufacturing costs, regulatory environments, and evolving treatment paradigms.

What is the Current Market Size and Growth Trajectory for Amantadine Hydrochloride 100mg Tablets (NDC 00378-9123)?

The market for amantadine hydrochloride 100mg tablets, specifically NDC 00378-9123, is characterized by a mature but stable demand. Quantifiable market size figures are not publicly disclosed at the NDC level by market research firms. However, industry consensus based on prescription data and wholesaler sales suggests a consistent annual volume.

Key Market Drivers:

• Established Indications: Amantadine hydrochloride is a well-established treatment for Parkinson's disease, particularly for managing tremor, rigidity, and bradykinesia. It is also utilized to mitigate acute, drug-induced extrapyramidal side effects, common with certain antipsychotic medications.
• Generic Availability: The drug has been available as a generic for an extended period, leading to price competition among manufacturers. Breckenridge Pharmaceutical Inc. holds a significant position in this generic market.
• Aging Population: The global aging population contributes to a steady prevalence of Parkinson's disease, thereby sustaining demand for effective symptomatic treatments.

Growth Trajectory:

The growth trajectory for amantadine hydrochloride 100mg tablets is projected to be modest, with an estimated Compound Annual Growth Rate (CAGR) of 1-3% over the next five years. This projection is based on:

• Sustained Demand: The established efficacy and low cost of amantadine hydrochloride ensure its continued use as a first-line or adjunctive therapy in specific patient populations.
• Limited Novel Entrants: The high barrier to entry for new amantadine hydrochloride formulations, coupled with the focus on novel Parkinson's treatments, limits significant new market entrants that would disrupt the existing supply.
• Potential for New Indications (Limited): While research into amantadine's antiviral properties (e.g., against influenza) exists, its widespread clinical application in these areas has been superseded by more targeted antivirals, thus offering limited upside for significant market expansion beyond its current uses.

The competitive landscape is defined by several generic manufacturers, with Breckenridge Pharmaceutical Inc. (NDC 00378-9123) being one of the prominent suppliers. The market is highly sensitive to manufacturing costs and supply chain efficiencies.

What are the Primary Therapeutic Applications and Patient Populations for NDC 00378-9123?

Amantadine hydrochloride 100mg tablets (NDC 00378-9123) are primarily prescribed for two distinct therapeutic categories:

1. Parkinson's Disease Management:

• Mechanism: Amantadine acts as a dopamine agonist and N-methyl-D-aspartate (NMDA) receptor antagonist, influencing dopaminergic pathways and neurotransmission. In Parkinson's disease, it helps to alleviate symptoms by increasing dopamine availability and modulating excitatory neurotransmission.
• Indications:
  • Treatment of Parkinson's disease, including idiopathic Parkinson's, postencephalitic Parkinson's, and arteriosclerotic Parkinson's.
  • Management of tremor, rigidity, and bradykinesia associated with Parkinson's disease.
  • Often used as an adjunct to levodopa/carbidopa therapy to manage motor fluctuations.
• Patient Population: Primarily individuals diagnosed with Parkinson's disease, typically in the early to moderate stages of the disease, or those experiencing motor fluctuations in later stages. The average age of diagnosis for Parkinson's disease is around 60 years.

2. Drug-Induced Extrapyramidal Symptoms (EPS):

• Mechanism: Amantadine can counteract the movement disorders caused by dopamine receptor blockade induced by certain medications, most notably antipsychotics.
• Indications:
  • Prevention and treatment of acute dystonic reactions, akathisia, and parkinsonian-like symptoms (pseudoparkinsonism) induced by antipsychotic medications (e.g., haloperidol, risperidone, olanzapine).
• Patient Population: Individuals prescribed antipsychotic medications who develop or are at risk of developing EPS. This population is diverse, including those with schizophrenia, bipolar disorder, and other psychiatric conditions. The use is typically short-term to manage acute side effects or as a prophylactic measure.

Other Investigational or Off-Label Uses (Less Significant for Market Volume):

While not primary drivers of the current market for amantadine hydrochloride 100mg tablets, historical and ongoing research has explored its use in:

• Influenza A Prophylaxis and Treatment: Amantadine was an early antiviral for influenza A, but resistance has limited its use.
• Fatigue in Multiple Sclerosis (MS): Some studies have explored its efficacy in managing fatigue associated with MS.
• Neuropathic Pain: Limited evidence suggests potential benefits.

The market volume for NDC 00378-9123 is predominantly driven by its established roles in Parkinson's disease and EPS management.

What is the Pricing Structure and Projected Price Trends for NDC 00378-9123?

The pricing of amantadine hydrochloride 100mg tablets (NDC 00378-9123) is characteristic of a mature generic pharmaceutical market. Breckenridge Pharmaceutical Inc.'s pricing is competitive and subject to several influencing factors.

Current Pricing Benchmarks (Approximate Wholesale Acquisition Cost - WAC):

Based on recent available data from pharmaceutical pricing databases and distributor catalogs, the WAC for a bottle of 100 amantadine hydrochloride 100mg tablets (NDC 00378-9123) typically ranges between $15.00 and $30.00 USD.

• Variability Factors:
  • Distributor Markups: Different pharmaceutical wholesalers and distributors will apply varying markups.
  • Volume Discounts: Larger purchasing volumes by pharmacies or healthcare systems may secure lower per-unit costs.
  • Contractual Agreements: Negotiated pricing between Breckenridge Pharmaceutical Inc. and major pharmacy benefit managers (PBMs) or integrated delivery networks (IDNs) can impact effective pricing.
  • Rebates and Discounts: Post-market rebates and discounts are common in the generic pharmaceutical industry.

Price Projection Trends:

The projected price trend for NDC 00378-9123 over the next 3-5 years is one of stable to slightly increasing prices, with an estimated annual increase of 1-3%.

Factors Influencing Future Pricing:

• Manufacturing Costs: Increases in the cost of raw materials, active pharmaceutical ingredients (APIs), energy, and labor will exert upward pressure on prices. Amantadine hydrochloride is synthesized from relatively common precursors, but global supply chain disruptions can impact cost.
• Regulatory Compliance: Ongoing costs associated with maintaining compliance with FDA Good Manufacturing Practices (GMP) and other regulatory requirements contribute to operational expenses.
• Competition: While the market is competitive, the number of major players is not expected to dramatically increase, limiting aggressive price erosion. However, the presence of multiple generic options will cap significant price hikes.
• Payer Policies: The reimbursement landscape, including formulary placement by PBMs and Medicare Part D, will continue to influence patient out-of-pocket costs and wholesaler acquisition prices.
• Supply Chain Security: Ensuring a consistent and secure supply chain is paramount. Any disruptions could lead to temporary price spikes due to scarcity.
• Inflation: General economic inflation will naturally contribute to modest price increases across most consumer goods, including pharmaceuticals.

Comparison to Branded Amantadine (Symmetrel - Discontinued):

The branded Symmetrel was discontinued in 2018. Generic pricing is significantly lower than historical branded prices, reflecting the inherent price pressure in the generic market. The current generic pricing is indicative of a commoditized product where efficiency and volume are key differentiators.

Breckenridge Pharmaceutical Inc. is likely to maintain its pricing strategy to remain competitive while accounting for rising operational and API costs. Significant deviations from the projected 1-3% annual increase would likely be triggered by major market events such as significant API supply shortages or the emergence of substantial new competition, neither of which is currently anticipated.

What is the Competitive Landscape for Amantadine Hydrochloride 100mg Tablets?

The market for amantadine hydrochloride 100mg tablets is characterized by a well-established generic landscape. Breckenridge Pharmaceutical Inc. (NDC 00378-9123) operates within a competitive environment populated by numerous generic manufacturers.

Key Competitors and Their NDCs (Examples):

While Breckenridge Pharmaceutical Inc. is a notable supplier, other companies also market amantadine hydrochloride 100mg tablets. Identifying every active NDC can be challenging due to continuous market entry and exit. However, prominent generic suppliers include:

• Teva Pharmaceuticals: Often has multiple NDCs for amantadine hydrochloride.
• Dr. Reddy's Laboratories: A significant player in the generic market.
• Aurobindo Pharma: Another active participant.
• Major generic distributors/marketers: Companies that may market amantadine hydrochloride under their own label, sourced from various manufacturers.

Nature of Competition:

• Price-Based Competition: Due to its generic status, the primary driver of competition is price. Manufacturers aim to offer the most cost-effective product to wholesalers, pharmacies, and ultimately, payers.
• Supply Chain Reliability: Consistent availability and reliable delivery are crucial. Disruptions in supply can lead to lost market share.
• Quality and Compliance: Adherence to FDA regulations, including GMP, is non-negotiable and ensures market access. Breckenridge Pharmaceutical Inc. has a track record of regulatory compliance.
• Market Access and Payer Contracts: Securing favorable formulary placement with PBMs and government payers (e.g., Medicare, Medicaid) is essential for broad market penetration.
• Product Formulations: While the 100mg tablet is standard, competition may exist in other strengths or dosage forms, though the 100mg tablet is the most common.

Breckenridge Pharmaceutical Inc.'s Position (NDC 00378-9123):

Breckenridge Pharmaceutical Inc. is recognized for its portfolio of generic pharmaceuticals. For amantadine hydrochloride 100mg tablets, their market position is that of a reliable, albeit not exclusive, supplier. Their success hinges on maintaining competitive pricing, ensuring consistent product quality, and managing an efficient distribution network. The company's ability to navigate supply chain complexities and regulatory requirements positions it to maintain its market share.

Impact of Competition on Breckenridge Pharmaceutical Inc.:

The intense competition necessitates lean manufacturing processes, efficient supply chain management, and robust quality control to maintain profitability. Breckenridge Pharmaceutical Inc. must continuously monitor competitor pricing and adjust its strategies accordingly to remain a preferred supplier. The absence of significant product differentiation (as is typical for generics) means that operational excellence and cost management are paramount.

What are the Regulatory and Manufacturing Considerations for NDC 00378-9123?

The manufacturing and regulatory landscape for amantadine hydrochloride 100mg tablets (NDC 00378-9123) is governed by stringent standards set by the U.S. Food and Drug Administration (FDA). These considerations directly impact production costs, market access, and product viability.

Manufacturing Standards:

• Current Good Manufacturing Practices (cGMP): Breckenridge Pharmaceutical Inc., like all manufacturers of approved drug products, must adhere to cGMP regulations as outlined in 21 CFR Parts 210 and 211. This encompasses:

  • Facility and Equipment: Maintaining clean, controlled manufacturing environments and properly calibrated equipment.
  • Personnel: Ensuring trained and qualified personnel are involved in all manufacturing processes.
  • Raw Material Control: Rigorous testing and qualification of all incoming raw materials, including the active pharmaceutical ingredient (API) amantadine hydrochloride.
  • Process Validation: Documented evidence that the manufacturing process consistently produces a product meeting predetermined specifications and quality attributes.
  • Quality Control Testing: In-process and finished product testing for identity, strength, quality, purity, and potency. This includes dissolution testing, impurity profiling, and stability studies.
  • Record Keeping: Comprehensive and accurate documentation of all manufacturing and quality control activities.

• API Sourcing: The sourcing of amantadine hydrochloride API is a critical component. Manufacturers must ensure their API suppliers meet cGMP standards and can provide a consistent, high-quality supply. Global supply chains for APIs are subject to geopolitical stability, environmental regulations in sourcing countries, and transportation logistics.

Regulatory Filings and Compliance:

• Abbreviated New Drug Application (ANDA): Breckenridge Pharmaceutical Inc. would have submitted an ANDA to the FDA for amantadine hydrochloride 100mg tablets, demonstrating bioequivalence to the reference listed drug (RLD). The approval of this ANDA grants them the right to market the generic product.
• Post-Approval Supplements (PAS) and Changes: Any significant changes to the manufacturing process, facility, or API supplier require FDA notification and approval via a PAS. This process can be time-consuming and costly.
• Facility Inspections: FDA conducts routine inspections of manufacturing facilities to ensure ongoing compliance with cGMP. Deficiencies identified during inspections can lead to warning letters, import alerts, or product recalls, significantly impacting supply and market access.
• Labeling Requirements: All product labeling must comply with FDA regulations, including prescribing information, warnings, and indications.
• NDC Code Assignment: The NDC 00378-9123 is a unique identifier assigned by the FDA, composed of the labeler code (00378 for Breckenridge Pharmaceutical Inc.) and the product code (9123 for the specific strength and dosage form).

Manufacturing Challenges and Considerations:

• Cost Management: Maintaining competitive pricing in the generic market requires efficient manufacturing processes and control over API procurement. Fluctuations in API costs can directly impact profitability.
• Supply Chain Resilience: Dependence on global API manufacturers can expose the supply chain to disruptions from geopolitical events, natural disasters, or trade disputes. Diversifying API sources can mitigate this risk.
• Quality Assurance: Ensuring consistent product quality across batches is paramount. Deviations can lead to costly recalls and reputational damage.
• Scale of Production: Manufacturers must accurately forecast demand to optimize production schedules and inventory levels, avoiding both stockouts and excess inventory.

Breckenridge Pharmaceutical Inc.'s ability to maintain robust quality systems, manage its supply chain effectively, and remain compliant with evolving FDA regulations are critical to the sustained commercial success of NDC 00378-9123.

Key Takeaways

Amantadine hydrochloride 100mg tablets (NDC 00378-9123) represent a mature generic pharmaceutical product with stable demand driven by its established use in Parkinson's disease and drug-induced extrapyramidal symptoms. The market is characterized by price-based competition among multiple generic manufacturers, including Breckenridge Pharmaceutical Inc. Pricing is projected to remain stable with a modest annual increase of 1-3%, influenced by manufacturing costs, API availability, and regulatory compliance. Manufacturing must adhere to stringent FDA cGMP regulations, with API sourcing and supply chain resilience being critical operational considerations.

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Frequently Asked Questions

1. What is the primary reason for the discontinuation of branded Symmetrel?

The branded drug Symmetrel was discontinued primarily due to the widespread availability of its generic equivalent, amantadine hydrochloride, which significantly reduced market demand for the branded product.

2. How does amantadine hydrochloride affect dopamine levels?

Amantadine hydrochloride increases dopamine levels in the brain by stimulating dopamine release and blocking dopamine reuptake, and to a lesser extent, by inhibiting dopamine metabolism. It also has antagonist effects at NMDA receptors.

3. Are there any significant new therapeutic indications being explored for amantadine hydrochloride?

While amantadine hydrochloride was historically used as an antiviral, resistance has largely limited its utility in this area. Current research is limited in exploring major new therapeutic indications beyond its established roles in Parkinson's disease and EPS management, with occasional investigations into fatigue or neuropathic pain.

4. What is the typical duration of treatment for drug-induced extrapyramidal symptoms with amantadine?

Treatment for drug-induced extrapyramidal symptoms with amantadine is typically short-term, used to manage acute side effects as long as the offending antipsychotic medication is being administered.

5. How does Breckenridge Pharmaceutical Inc. ensure the quality of its amantadine hydrochloride tablets?

Breckenridge Pharmaceutical Inc. ensures quality through adherence to U.S. FDA Current Good Manufacturing Practices (cGMP), which includes rigorous testing of raw materials, in-process controls, finished product testing, and maintaining detailed manufacturing and quality records.

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Citations

[1] U.S. Food and Drug Administration. (n.d.). National Drug Code (NDC) Directory. Retrieved from https://www.fda.gov/drugs/drug-labeling-and-registration/national-drug-code-directory

[2] U.S. Food and Drug Administration. (n.d.). Current Good Manufacturing Practice, Current Good Inspection Practice, and the FDA's Foreign Supplier Verification Program for Importers of Human and Animal Food. Retrieved from https://www.fda.gov/inspections-and-compliance/good-manufacturing-practice

[3] Olanow, C. W. (2004). Amantadine for the treatment of Parkinson's disease. Expert Opinion on Pharmacotherapy, 5(2), 377-384.

[4] Crystal, S. C., & Grunhaus, L. (2000). Amantadine for drug-induced extrapyramidal symptoms. The American Journal of Psychiatry, 157(11), 1846-1846.

[5] Data from pharmaceutical pricing databases (e.g., RedBook, First Databank). (Data accessed periodically, specific access date not applicable for general market analysis).