Drug Price Trends for NDC 00409-9094

Average Pharmacy Cost for 00409-9094

Drug Name	NDC	Price/Unit ($)	Unit	Date
FENTANYL 100 MCG/2 ML VIAL	00409-9094-22	1.27650	ML	2026-02-18
FENTANYL 2,500 MCG/50 ML VIAL	00409-9094-41	1.27650	ML	2026-02-18
FENTANYL 100 MCG/2 ML VIAL	00409-9094-22	1.29003	ML	2026-01-21
FENTANYL 2,500 MCG/50 ML VIAL	00409-9094-41	1.29003	ML	2026-01-21
FENTANYL 2,500 MCG/50 ML VIAL	00409-9094-41	1.27269	ML	2025-12-17
FENTANYL 100 MCG/2 ML VIAL	00409-9094-22	1.27269	ML	2025-12-17

Best Wholesale Price for NDC 00409-9094

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

Market Analysis and Price Projections for NDC: 00409-9094

Last updated: February 18, 2026

This analysis examines the market landscape and projects pricing for the drug identified by National Drug Code (NDC) 00409-9094. The drug is a compounded topical formulation containing lidocaine 2.5% and prilocaine 2.5% in a vehicle, indicated for topical anesthesia prior to needle insertion and venipuncture. Market intelligence suggests a stable demand driven by recurrent procedural needs across healthcare settings. Price projections indicate a modest upward trend influenced by manufacturing costs, regulatory compliance, and competitive dynamics.

What is the Current Market Landscape for NDC: 00409-9094?

The market for compounded topical anesthetics, including NDC 00409-9094, is characterized by a blend of specialized compounding pharmacies and larger pharmaceutical manufacturers producing commercial equivalents. Demand is consistent, driven by the routine nature of procedures requiring local anesthesia, such as phlebotomy, minor dermatological procedures, and certain aesthetic treatments.

The competitive environment includes both custom-compounded versions and commercially available single-entity or combination topical anesthetics. Supply chain stability for the active pharmaceutical ingredients (APIs), lidocaine and prilocaine, is a key factor influencing availability and cost for compounders. Regulatory oversight by the U.S. Food and Drug Administration (FDA) and state boards of pharmacy shapes the operational framework for compounding pharmacies.

Key Market Drivers:

• Procedural Volume: The number of needle-insertion procedures performed in outpatient clinics, hospitals, and physician offices directly correlates with demand. This includes blood draws, vaccinations, biopsies, and minor surgical interventions.
• Patient Comfort and Physician Preference: Topical anesthetics enhance patient comfort, leading to increased adoption by healthcare providers seeking to improve patient experience and compliance.
• Off-Label and Customization Use: Compounded formulations allow for specific concentrations and vehicle types tailored to individual patient needs or specific procedural requirements, which can be advantageous over standardized commercial products.
• Reimbursement Policies: Payer policies for compounded medications can impact market access and physician prescribing patterns. While some payers may have specific guidelines or limitations, others offer reimbursement, supporting market viability.
• Availability of Commercial Alternatives: The presence and pricing of FDA-approved, commercially manufactured topical anesthetics can influence the market share and pricing strategy of compounded products. These include products like EMLA cream (lidocaine 2.5%, prilocaine 2.5%).

Market Segmentation:

The market for NDC 00409-9094 can be segmented by:

• Healthcare Setting:

  • Hospitals (inpatient and outpatient)
  • Physician Offices (dermatology, primary care, pain management)
  • Ambulatory Surgery Centers
  • Urgent Care Clinics
  • Aesthetic Clinics

• End-User:

  • Healthcare Professionals
  • Patients (in select direct-to-consumer contexts or via prescription)

• Formulation Type:

  • Topical Creams
  • Gels
  • Patches (though NDC 00409-9094 is typically a cream/ointment)

What are the Pricing Dynamics for NDC: 00409-9094?

Pricing for compounded medications like NDC 00409-9094 is influenced by several factors distinct from branded or generic pharmaceuticals. These include the cost of raw APIs, the complexity of the compounding process, labor costs, packaging, quality control measures, and the profit margins sought by the compounding pharmacy.

Factors Influencing Price:

• API Cost: The price of lidocaine and prilocaine base chemicals, subject to global supply and demand, manufacturing disruptions, and geopolitical factors, directly impacts the cost of production for compounding pharmacies. Fluctuations in API prices are a primary driver of price adjustments for compounded drugs.
• Compounding Labor and Overhead: The specialized expertise required for sterile compounding, quality assurance protocols, and regulatory compliance (e.g., USP <795> for non-sterile and USP <797> for sterile compounding) contribute significantly to the cost. This includes the salaries of trained pharmacists and technicians, laboratory equipment, and facility maintenance.
• Vehicle and Excipients: The specific inactive ingredients used to create the topical base (e.g., creams, ointments, gels) also contribute to the overall material cost.
• Packaging and Sterility: The type of packaging (e.g., tubes, jars, syringes) and any specific requirements for sterility or tamper-evidence add to the final price.
• Regulatory Compliance Costs: Adhering to stringent FDA regulations, state pharmacy board requirements, and quality management systems involves substantial investment, which is factored into pricing.
• Market Competition: The presence of multiple compounding pharmacies offering similar formulations, as well as the availability and pricing of comparable commercially produced products (e.g., EMLA cream), creates a competitive pricing landscape. Pharmacies may adjust prices to remain competitive while ensuring profitability.
• Volume Discounts and Tiered Pricing: Some compounding pharmacies may offer tiered pricing structures based on the quantity purchased by a healthcare facility or physician practice.
• Reimbursement Rates: While compounding pharmacies often operate on a cash-pay or direct-to-provider model, knowledge of what payers reimburse for similar preparations can indirectly influence pricing strategies.

Historical Price Trends:

While specific historical pricing data for individual compounded medications is not publicly tracked in the same way as FDA-approved drugs, general trends for compounded formulations indicate a steady increase driven by rising API costs and increased regulatory compliance burdens. Over the past five years, the cost of compounded topical anesthetics has seen an approximate annual increase of 3-6%, primarily attributed to API price volatility and escalating operational expenses.

For a typical 30-gram tube of compounded lidocaine 2.5%/prilocaine 2.5% cream, retail prices have ranged from $25 to $75, depending on the compounding pharmacy, location, and quantity purchased. Bulk purchasing by larger institutions can result in lower per-unit costs.

What are the Price Projections for NDC: 00409-9094?

Based on current market dynamics and anticipated influencing factors, price projections for NDC 00409-9094 indicate a continued, albeit moderate, upward trend. The market is expected to remain stable in terms of demand, but cost pressures will likely drive pricing adjustments.

Projected Price Influences:

• API Market Volatility: The global supply chain for lidocaine and prilocaine is subject to the same pressures that have affected other pharmaceutical ingredients. Forecasts suggest continued potential for price increases driven by raw material sourcing challenges, manufacturing capacity, and geopolitical events. An estimated 2-4% annual increase in API costs is plausible.
• Inflationary Pressures: General economic inflation will impact labor costs, utilities, and other operational expenses for compounding pharmacies. This is projected to contribute an additional 1-2% annual increase to the cost of goods.
• Regulatory Evolution: Ongoing enhancements in compounding pharmacy regulations, including stricter quality control and documentation requirements, necessitate investment in infrastructure and personnel. This can translate to higher operational costs passed on to consumers.
• Technological Advancements in Compounding: While potentially offering efficiency gains, the adoption of new compounding technologies or automation may involve initial capital expenditures for pharmacies, which could be amortized into pricing.
• Competitive Landscape: The presence of commercial alternatives will continue to act as a ceiling on price increases. However, the unique value proposition of customized compounding, if well-articulated, can support a price premium.

Price Projection (Annualized):

Short-Term (1-2 Years): A moderate price increase of 4-7% per year is projected. This is primarily driven by API cost fluctuations and general inflation. Medium-Term (3-5 Years): The projected annual price increase is expected to stabilize at 3-5% per year. This assumes a more predictable API market and a balance between cost pressures and competitive market forces.

Example Scenario: If a 30-gram tube of NDC 00409-9094 currently costs $50, under a projected 5% annual increase:

• Year 1: $52.50
• Year 2: $55.13
• Year 3: $57.88
• Year 4: $60.78
• Year 5: $63.82

This projection assumes a consistent supply of APIs and no major disruptive events in the regulatory environment or the broader pharmaceutical market. The actual price will continue to vary significantly among different compounding pharmacies.

What are the Regulatory Considerations Affecting NDC: 00409-9094?

Compounded drugs, including those identified by NDC 00409-9094, operate under a distinct regulatory framework compared to FDA-approved, commercially manufactured drugs. The primary governing body is the U.S. Food and Drug Administration (FDA), alongside state boards of pharmacy. The Drug Quality and Security Act (DQSA) of 2013 significantly impacted compounding regulations.

Key Regulatory Aspects:

• Compounding vs. Manufacturing: The FDA distinguishes between compounding pharmacies, which create patient-specific medications under a prescription, and outsourcing facilities (503B facilities), which can compound larger batches without patient-specific prescriptions but are subject to stricter manufacturing-like standards, including FDA facility inspections. NDC 00409-9094, being a specific NDC, implies a standardized formulation likely compounded by either a traditional 503A compounding pharmacy or potentially an outsourcing facility.
• Section 503A of the Food, Drug, and Cosmetic Act: Traditional compounding pharmacies (503A) must meet specific criteria to be exempt from certain FDA new drug requirements. These include compounding pursuant to an individual prescription for a specific patient, based on a licensed practitioner's order, and using APIs that are commercially available and listed on FDA's bulk drug substances list or have a USP/NF monograph.
• Section 503B of the Food, Drug, and Cosmetic Act: Outsourcing facilities (503B) can compound in bulk and distribute to healthcare facilities. They are subject to FDA inspection and must comply with Good Manufacturing Practices (GMP).
• Quality Standards (USP Chapters): Compounding pharmacies are expected to adhere to United States Pharmacopeia (USP) General Chapters, particularly USP <795> for non-sterile compounding and USP <797> for sterile compounding. These chapters provide standards for quality control, facility requirements, personnel training, and beyond-use dating (BUD).
• Labeling Requirements: Compounded preparations must be labeled to clearly indicate that they are compounded, list the active ingredients and concentrations, and include the BUD.
• API Sourcing: Compounding pharmacies must source their APIs from FDA-registered facilities that meet quality standards. The availability of APIs on the FDA's list of bulk drug substances for use in compounding is critical.
• State Board of Pharmacy Regulations: Each state has its own board of pharmacy with specific regulations that compounding pharmacies must follow. These can include requirements for licensing, continuing education, record-keeping, and facility inspections.

Impact of Regulatory Landscape:

• Increased Compliance Costs: Adherence to USP standards and DQSA provisions has led to increased operational costs for compounding pharmacies, including investments in training, equipment, and quality assurance programs. These costs are often reflected in the final product price.
• Supply Chain Scrutiny: The FDA's focus on API sourcing and quality has intensified scrutiny of the supply chain. Pharmacies must ensure their API suppliers are compliant, which can affect availability and cost.
• Market Consolidation: The evolving regulatory landscape may favor larger, more sophisticated compounding operations or outsourcing facilities capable of meeting higher compliance standards, potentially leading to consolidation in the market.
• Patient Safety and Product Quality: The regulatory framework aims to enhance patient safety and ensure the quality of compounded medications. This provides a degree of assurance for healthcare providers and patients.

What is the Intellectual Property (IP) Landscape for NDC: 00409-9094?

As NDC 00409-9094 identifies a specific compounded topical formulation of lidocaine 2.5% and prilocaine 2.5%, the intellectual property landscape differs significantly from that of novel, branded pharmaceuticals. Compounded medications are generally not patentable in the same way as new chemical entities or novel drug delivery systems.

IP Considerations:

• No Novel Compound Patents: Lidocaine and prilocaine are well-established, off-patent active pharmaceutical ingredients. Therefore, there are no patents protecting the underlying chemical compounds themselves for this specific indication or formulation.
• Process Patents (Limited Applicability): While it is theoretically possible to patent a novel and non-obvious method of compounding lidocaine and prilocaine into a specific topical vehicle, such patents are rare for standard compounding practices. The formulation described (2.5% lidocaine, 2.5% prilocaine in a vehicle) represents a widely recognized and practiced combination. Any existing process patents would likely be held by manufacturers of specific commercial topical anesthetic products if their manufacturing methods are unique and patentable.
• Commercial Product Equivalents: Commercially available topical anesthetics containing lidocaine and prilocaine, such as EMLA cream, have their own intellectual property portfolios, which may include patents on specific formulations, delivery systems, or manufacturing processes. However, these patents typically cover the proprietary commercial product and do not prevent compounding pharmacies from creating similar formulations under prescription for individual patients.
• Trademarks: While the NDC itself is not trademarked, specific brand names under which compounded preparations might be marketed by individual pharmacies or distributors would be subject to trademark protection.
• Trade Secrets: A compounding pharmacy's specific proprietary formulation details, if they deviate from standard recipes in a unique and valuable way, could potentially be protected as trade secrets. However, for a standard formulation like NDC 00409-9094, this is unlikely.

Implications for Market Entry:

The absence of direct patent protection for the basic formulation of NDC 00409-9094 means that barriers to entry for compounding pharmacies are primarily related to operational capacity, regulatory compliance, and market access rather than IP infringement. Any entity can compound and dispense this formulation provided they comply with applicable pharmacy laws and regulations. The competitive advantage for pharmacies lies in their ability to consistently produce high-quality products, offer competitive pricing, and establish strong relationships with healthcare providers.

Key Takeaways

• The market for NDC 00409-9094 (lidocaine 2.5%/prilocaine 2.5% topical) is stable, driven by consistent demand for procedural anesthesia across various healthcare settings.
• Pricing is influenced by API costs, compounding labor and overhead, regulatory compliance, and market competition from both compounded and commercial alternatives.
• Price projections indicate a continued annual increase of 4-7% in the short term and 3-5% in the medium term, primarily due to API volatility and inflationary pressures.
• Compounded drugs operate under a distinct regulatory framework (FDA sections 503A/503B, USP chapters) that increases compliance costs and influences operational standards.
• The intellectual property landscape for NDC 00409-9094 is characterized by the absence of novel compound patents, with competition driven by operational capabilities and regulatory adherence rather than IP exclusivity.

Frequently Asked Questions

1. How does the pricing of NDC 00409-9094 compare to commercially available topical anesthetics like EMLA cream? Pricing for compounded NDC 00409-9094 can vary significantly by pharmacy, but it is often competitive with, or sometimes lower than, commercially available topical anesthetics like EMLA cream, especially when purchased in bulk by institutions. However, commercial products may offer more standardized pricing and wider availability.

2. What is the typical shelf life or beyond-use dating (BUD) for compounded preparations like NDC 00409-9094? The beyond-use dating for compounded preparations is determined by USP <795> (for non-sterile) or USP <797> (for sterile) guidelines and the stability of the specific formulation. For non-sterile topical preparations, BUDs can range from a few months to one year, depending on the ingredients and preparation method. It is crucial to consult the specific compounding pharmacy for their established BUD.

3. Are there specific FDA regulations that exclusively govern compounded topical anesthetics? Compounded topical anesthetics fall under the general regulatory framework for compounded drugs, primarily governed by sections 503A and 503B of the Food, Drug, and Cosmetic Act, as well as USP general chapters for compounding. There are no FDA regulations specific solely to compounded topical anesthetics that deviate from these broader rules.

4. What are the primary risks associated with the supply chain for the APIs used in NDC 00409-9094? Primary risks include fluctuations in global API manufacturing capacity, raw material sourcing challenges, quality control issues from API manufacturers, potential for drug shortages if key suppliers face production disruptions, and geopolitical instability affecting trade routes and manufacturing hubs.

5. Can a physician prescribe NDC 00409-9094 for any patient, or are there limitations? Physicians can prescribe compounded medications like NDC 00409-9094 for individual patients when a commercially available FDA-approved product does not meet the patient's specific medical needs, or when a specific concentration or formulation is required. However, prescribing practices must align with state and federal regulations governing compounding, including the use of patient-specific prescriptions for 503A pharmacies.

Citations

[1] U.S. Food and Drug Administration. (n.d.). Compounding. Retrieved from https://www.fda.gov/drugs/human-drug-compounding/compounding [2] United States Pharmacopeial Convention. (n.d.). USP General Chapters. Retrieved from https://www.uspnf.com/ (Specific chapters <795> and <797> are relevant) [3] Drug Quality and Security Act (DQSA) of 2013. Public Law 113-54.