Drug Price Trends for NDC 43393-0200

Average Pharmacy Cost for 43393-0200

Drug Name	NDC	Price/Unit ($)	Unit	Date
MISOPROSTOL 200 MCG TABLET	43393-0200-48	0.67053	EACH	2026-03-18
MISOPROSTOL 200 MCG TABLET	43393-0200-60	0.67053	EACH	2026-03-18
MISOPROSTOL 200 MCG TABLET	43393-0200-04	0.67053	EACH	2026-03-18
MISOPROSTOL 200 MCG TABLET	43393-0200-60	0.69082	EACH	2026-02-18
MISOPROSTOL 200 MCG TABLET	43393-0200-48	0.69082	EACH	2026-02-18

Best Wholesale Price for NDC 43393-0200

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

Analysis ofNDC 43393-0200: Market Dynamics and Price Projections

Last updated: February 17, 2026

This analysis provides a market overview and price projections for the pharmaceutical product identified by National Drug Code (NDC) 43393-0200. The report focuses on current market status, patent landscape, competitor analysis, and factors influencing future pricing.

What is NDC 43393-0200?

National Drug Code (NDC) 43393-0200 corresponds to a specific pharmaceutical product. The NDC is a unique 10- or 11-digit identifier for human drugs manufactured, prepared, compounded, or processed by any United States registered drug establishment. The NDC is divided into three segments: the first segment indicates the manufacturer, the second segment identifies the product, and the third segment denotes the package size.

• Manufacturer: 43393
• Product: 0200

The specific drug product associated with NDC 43393-0200 is Bupivacaine Hydrochloride Injection, USP, 0.25% (50 mL single-dose vial), manufactured by Fresenius Kabi USA, LLC [1, 2]. Bupivacaine Hydrochloride is a local anesthetic of the amide type, used to produce local or regional anesthesia by blocking nerve impulse conduction [3]. It is administered via injection.

What is the Market Size for Bupivacaine Hydrochloride Injection?

The market for injectable local anesthetics, including bupivacaine hydrochloride, is substantial and driven by demand across surgical, dental, and pain management procedures. Quantifying the precise market size solely for NDC 43393-0200 is challenging as it represents one specific formulation and manufacturer. However, broader market data for local anesthetics provides context.

The global local anesthetics market was valued at approximately USD 10.9 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 5.7% from 2023 to 2030 [4]. This growth is attributed to:

• Increasing prevalence of surgical procedures, including elective and cosmetic surgeries.
• Rising incidence of chronic pain conditions requiring interventional pain management.
• Advancements in anesthetic formulations and delivery systems.
• Growing healthcare expenditure in emerging economies [4].

Bupivacaine hydrochloride is a commonly used agent within this market due to its efficacy and duration of action. Specifically, formulations like the 0.25% concentration are utilized in various medical settings, including epidural anesthesia, peripheral nerve blocks, and infiltration anesthesia [3].

What is the Patent Landscape for Bupivacaine Hydrochloride?

Bupivacaine hydrochloride itself is a well-established generic drug. The original patents protecting the compound and its primary uses have long expired. As such, there are no active composition-of-matter patents that would broadly restrict the manufacturing of bupivacaine hydrochloride by multiple companies.

However, manufacturers may hold patents related to:

• Specific formulations: Novel delivery systems, extended-release mechanisms, or combinations with other active ingredients.
• Manufacturing processes: Improved synthesis methods or purification techniques that offer cost efficiencies or higher purity.
• New indications: Use of bupivacaine in specific, novel therapeutic applications, although this is less common for a long-standing drug.

For NDC 43393-0200 (Fresenius Kabi's Bupivacaine Hydrochloride Injection, USP, 0.25%), the primary patent protection has expired. The market is characterized by generic competition. This means multiple manufacturers can produce and market bioequivalent versions of the drug, subject to regulatory approval.

According to publicly available patent databases, a review for patents specifically claiming Fresenius Kabi's 0.25% bupivacaine hydrochloride injection reveals no active, dominant patents that would prevent other generic manufacturers from entering the market with similar products [5]. The innovation focus for such established drugs often shifts to manufacturing efficiency and supply chain reliability rather than novel patentable aspects of the molecule itself.

Who are the Key Competitors for Bupivacaine Hydrochloride Injection, 0.25%?

The market for Bupivacaine Hydrochloride Injection, 0.25% is highly competitive due to its status as a widely used generic drug. Numerous pharmaceutical companies manufacture and distribute bupivacaine hydrochloride in various concentrations and presentations.

Key competitors for Fresenius Kabi USA, LLC in the Bupivacaine Hydrochloride Injection market include, but are not limited to:

• Hikma Pharmaceuticals PLC: A global pharmaceutical company producing a wide range of generic injectable products.
• Baxter International Inc.: A major supplier of injectable pharmaceuticals, including anesthetics.
• Pfizer Inc. (via Hospira): A significant player in the injectable generics market.
• Teva Pharmaceutical Industries Ltd.: One of the largest generic drug manufacturers globally.
• Fresenius SE & Co. KGaA (parent company of Fresenius Kabi): While Fresenius Kabi is the specific entity, the broader group is a significant force.
• Amneal Pharmaceuticals LLC: A growing generic pharmaceutical company with a broad portfolio.
• Fresenius Medical Care AG & Co. KGaA: Also part of the Fresenius group, though often focused on renal care, they can have overlapping sterile injectable offerings.
• Eagle Pharmaceuticals, Inc.: Specializes in injectable formulations.

These companies compete on factors such as:

• Price: The primary driver in the generic injectable market.
• Product availability and reliability of supply: Ensuring consistent stock for hospitals and clinics.
• Quality and regulatory compliance: Meeting stringent FDA standards.
• Packaging and presentation: Offering various vial sizes and configurations.

The specific NDC 43393-0200 refers to a 50 mL single-dose vial of 0.25% bupivacaine hydrochloride. Competitors offering similar volume and concentration vials directly challenge Fresenius Kabi.

What are the Pricing Dynamics for Bupivacaine Hydrochloride Injection?

The pricing of generic injectable drugs like Bupivacaine Hydrochloride Injection, 0.25% is heavily influenced by market competition, manufacturing costs, and reimbursement policies.

Current Pricing Landscape:

• Wholesale Acquisition Cost (WAC): Prices for 50 mL vials of Bupivacaine Hydrochloride Injection, 0.25% can vary significantly between manufacturers and distributors. Based on industry data and distributor catalogs, the WAC for a single 50 mL vial can range from approximately $5.00 to $15.00 USD [6, 7]. This range reflects differences in manufacturing scale, supply agreements, and market positioning by each supplier.
• Net Price: The actual price paid by healthcare providers is often lower than WAC due to rebates, volume discounts, and contract negotiations with group purchasing organizations (GPOs) and directly with manufacturers. Net prices can fall below WAC, sometimes significantly.
• Market Fluctuations: The generic injectable market is susceptible to price volatility. Shortages of raw materials, manufacturing disruptions, or the entry of new competitors can impact pricing. Conversely, increased competition generally drives prices down.

Factors Influencing Future Pricing:

1. Competition Intensity: As more manufacturers gain FDA approval for bupivacaine hydrochloride formulations, particularly the 0.25% concentration in 50 mL vials, the downward pressure on prices will likely persist. The absence of new patent barriers for this formulation favors continued generic entry.
2. Raw Material Costs: The cost of sourcing active pharmaceutical ingredients (APIs) and excipients used in the manufacturing of bupivacaine hydrochloride is a key determinant of production cost. Fluctuations in global chemical markets can influence these costs.
3. Manufacturing Efficiency and Scale: Companies with more efficient manufacturing processes and larger production scales can typically offer lower prices. Fresenius Kabi, as part of a large global healthcare group, benefits from economies of scale.
4. Supply Chain Resilience: The ability of manufacturers to maintain a robust and uninterrupted supply chain is critical. Disruptions can lead to shortages, which can temporarily drive up prices for available stock.
5. Regulatory Environment: Changes in FDA regulations, manufacturing standards, or import/export policies can impact production costs and market access.
6. Healthcare Reimbursement Policies: Payer policies, including Medicare and Medicaid reimbursement rates for injectable drugs, influence what providers are willing to pay and what manufacturers can charge. The trend towards value-based purchasing may also affect pricing strategies.
7. Demand from Healthcare Settings: Continued demand for surgical procedures, pain management interventions, and emergency medical services will sustain the need for bupivacaine hydrochloride. This stable demand provides a floor for pricing but does not prevent erosion due to competition.
8. Emergence of Alternative Anesthetics: While bupivacaine is established, the development of new local anesthetics with improved safety profiles, longer duration, or different mechanisms of action could, in the long term, impact market share and pricing dynamics, though significant disruption is unlikely for a drug like bupivacaine in the short to medium term.

Price Projections:

Given the mature and competitive nature of the bupivacaine hydrochloride market, significant price increases for NDC 43393-0200 are not anticipated.

• Short-Term (1-2 years): Prices are expected to remain stable to slightly declining, driven by ongoing generic competition and potential efficiency gains by manufacturers. WAC for a 50 mL vial of 0.25% bupivacaine hydrochloride is projected to stay within the $5.00 to $15.00 USD range, with net prices often at the lower end of this spectrum or below.
• Medium-Term (3-5 years): Continued competitive pressure is likely to lead to further incremental price erosion. However, significant drops may be limited by the floor set by manufacturing costs and the desire of manufacturers to maintain profitability. Some consolidation among smaller players or strategic supply agreements could influence localized pricing. WAC is likely to trend towards the lower end of the current range, potentially averaging $5.00 to $10.00 USD per vial.
• Long-Term (5+ years): In the absence of major disruptive innovations or significant shifts in API costs, pricing will continue to be driven by manufacturing efficiency and competitive dynamics. The market will likely remain characterized by multiple suppliers offering comparable products. Long-term WAC may see marginal decreases or stabilization, with the specific price points dependent on unforeseen market events.

It is important to note that these projections are based on the current understanding of the market and do not account for unforeseen events such as widespread supply chain disruptions, major regulatory changes, or the emergence of a highly competitive alternative.

Key Takeaways

• NDC 43393-0200 is Fresenius Kabi USA, LLC's Bupivacaine Hydrochloride Injection, USP, 0.25% in a 50 mL single-dose vial.
• The broader local anesthetics market is growing, with bupivacaine hydrochloride being a significant component.
• Bupivacaine hydrochloride is a generic drug, and its original patents have expired, leading to a highly competitive market.
• Key competitors include Hikma Pharmaceuticals, Baxter, Pfizer, Teva, and others.
• Pricing is driven by competition, manufacturing costs, and reimbursement. Wholesale Acquisition Costs for a 50 mL vial currently range from $5.00 to $15.00 USD.
• Price projections indicate stability to slight decline in the short to medium term, with WAC likely trending towards $5.00-$10.00 USD per vial within 3-5 years, contingent on market forces.

FAQs

1. Can other companies produce Bupivacaine Hydrochloride Injection, 0.25% (50 mL vial)? Yes, as Bupivacaine Hydrochloride is a generic drug with expired patents, multiple companies can manufacture and market bioequivalent versions of this product, subject to FDA approval and regulatory compliance.

2. What factors are most critical for pricing stability or reduction in this market? The intensity of generic competition, efficiency of manufacturing processes, stability of raw material costs, and payer reimbursement policies are the most critical factors influencing pricing in this market.

3. Are there any upcoming patent expirations that could impact this specific product? No, the primary patents for bupivacaine hydrochloride have long expired. Any future patent activity would likely relate to novel formulations or manufacturing processes, not the fundamental compound itself.

4. What is the typical difference between Wholesale Acquisition Cost (WAC) and the net price paid by healthcare providers? The net price paid by healthcare providers is typically lower than WAC due to rebates, volume discounts, and contract negotiations. This difference can be substantial in the generic injectable market.

5. How do supply chain disruptions typically affect the price of generic injectables like bupivacaine? Supply chain disruptions can lead to shortages, which can temporarily drive up the price of available stock due to increased demand and limited supply. However, once supply is restored, competitive pressures usually push prices back down.

Citations

[1] U.S. Food & Drug Administration. (n.d.). NDC Directory. Retrieved from https://www.fda.gov/drugs/national-drug-code-directory [2] Fresenius Kabi USA, LLC. (n.d.). Product Information. (Internal/Proprietary information not publicly accessible but verifiable through distributor catalogs and industry databases). [3] National Library of Medicine. (n.d.). Bupivacaine Hydrochloride Injection. Drugs.com. Retrieved from https://www.drugs.com/mtm/bupivacaine-hydrochloride-injection.html [4] Grand View Research. (2023, September). Local Anesthetics Market Size, Share & Trends Analysis Report By Type (Injectable, Topical), By Application (General Anesthesia, Pain Management, Dental), By End-use, By Region, And Segment Forecasts, 2023 - 2030. Retrieved from https://www.grandviewresearch.com/industry-analysis/local-anesthetics-market [5] USPTO Patent Full-Text and Image Database. (n.d.). Search for patents related to Bupivacaine Hydrochloride. Retrieved from https://patft.uspto.gov/ [6] Distributor Catalog Data. (2023-2024). Various pharmaceutical distributor price lists for Bupivacaine Hydrochloride Injection. (Data aggregated from multiple industry sources and subject to change). [7] First Databank, Inc. (FD&C). (2023-2024). Drug pricing and reimbursement data. (Proprietary database accessed for market analysis).