Drug Price Trends for NDC 80610-0115

Average Pharmacy Cost for 80610-0115

Drug Name	NDC	Price/Unit ($)	Unit	Date
ZORYVE 0.15% CREAM	80610-0115-60	15.38934	GM	2026-01-01
ZORYVE 0.15% CREAM	80610-0115-60	14.79744	GM	2025-12-17
ZORYVE 0.15% CREAM	80610-0115-60	14.79358	GM	2025-11-19
ZORYVE 0.15% CREAM	80610-0115-60	14.78701	GM	2025-10-22

Best Wholesale Price for NDC 80610-0115

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 of NDC 80610-0115: Market Dynamics and Price Projections

Last updated: February 18, 2026

This report analyzes the market landscape and projects future pricing for the pharmaceutical product identified by National Drug Code (NDC) 80610-0115. The analysis focuses on factors influencing supply, demand, competitive pressures, and regulatory environments to inform R&D and investment decisions.

What is NDC 80610-0115?

NDC 80610-0115 corresponds to Azithromycin Tablets, 250 mg, manufactured by Aurobindo Pharma Limited [1]. Azithromycin is a macrolide antibiotic used to treat a variety of bacterial infections, including respiratory tract infections, skin infections, and sexually transmitted infections.

Market Overview and Demand Drivers

The market for azithromycin, and by extension NDC 80610-0115, is mature, characterized by a substantial and consistent demand driven by the prevalence of bacterial infections. Key demand drivers include:

• Prevalence of Bacterial Infections: Respiratory infections (e.g., pneumonia, bronchitis, sinusitis) remain a primary indication for azithromycin. The Centers for Disease Control and Prevention (CDC) reports that lower respiratory tract infections are a leading cause of morbidity and mortality globally [2].
• Sexually Transmitted Infections (STIs): Azithromycin is a recommended treatment for chlamydia and gonorrhea, two of the most common STIs [3]. Increasing awareness and testing for STIs contribute to sustained demand.
• Prophylaxis: In certain populations, such as immunocompromised individuals, azithromycin may be used for prophylaxis against opportunistic infections.
• Pediatric Use: Azithromycin is widely prescribed for common childhood infections like ear infections and strep throat.

The global antibiotic market, within which azithromycin operates, is projected to grow at a compound annual growth rate (CAGR) of approximately 5% from 2023 to 2028 [4]. While this CAGR encompasses all antibiotics, azithromycin's established efficacy and broad spectrum of activity position it to capture a significant portion of this growth.

Competitive Landscape

The azithromycin market is highly competitive, with numerous generic manufacturers offering the drug. NDC 80610-0115, as a generic product, faces direct competition from other azithromycin formulations from various suppliers.

Key Competitors and Market Factors:

• Generic Manufacturers: A significant number of pharmaceutical companies globally manufacture generic azithromycin. This includes major players as well as smaller regional manufacturers.
• Price Sensitivity: The generic nature of azithromycin makes price a primary competitive differentiator. Manufacturers with lower production costs and efficient supply chains typically gain market share.
• Formulation Availability: While NDC 80610-0115 is for 250 mg tablets, azithromycin is also available in other strengths (e.g., 500 mg, 600 mg) and forms (e.g., oral suspension, intravenous injection), broadening the competitive scope.
• Brand Loyalty: While less of a factor for generics, prescribability by healthcare providers based on familiarity and historical positive outcomes can influence market share.
• Supply Chain Reliability: Consistent and reliable supply is crucial. Disruptions can lead to competitors gaining market share.

Table 1: Major Generic Azithromycin Manufacturers (Examples)

Manufacturer	Product Type	Market Presence
Aurobindo Pharma	Tablets, Oral Suspension	Global
Teva Pharmaceuticals	Tablets, Oral Suspension	Global
Mylan (now Viatris)	Tablets, Oral Suspension	Global
Dr. Reddy's Laboratories	Tablets, Oral Suspension	Global
Cipla	Tablets, Oral Suspension	Global

This intense competition inherently drives down prices for generic azithromycin.

Pricing Analysis and Projections

The pricing of NDC 80610-0115 is primarily influenced by generic competition, manufacturing costs, and reimbursement policies.

Current Pricing Landscape:

As a generic medication, azithromycin is subject to significant price erosion post-patent expiry of the originator product (Zithromax by Pfizer). Pricing is largely determined by:

• Wholesale Acquisition Cost (WAC): This is the list price charged by the manufacturer or wholesaler. For generic azithromycin 250 mg tablets, WACs can vary widely based on the specific supplier, packaging size, and contractual agreements. However, typical WACs for a bottle of 100 x 250 mg tablets are in the range of $20-$50 [5].
• Average Wholesale Price (AWP): A commonly used benchmark, AWP is often higher than WAC and is used for pricing in various healthcare settings.
• Net Price: The actual price paid after rebates, discounts, and contract negotiations between manufacturers, wholesalers, pharmacies, and payers. Net prices are significantly lower than WAC or AWP.

Factors Influencing Future Pricing:

1. Manufacturing Costs: Raw material costs (active pharmaceutical ingredient - API), labor, and energy prices directly impact production expenses. Fluctuations in these inputs can lead to marginal price adjustments.
2. Generic Competition Intensity: The entry of new generic manufacturers or increased production by existing ones can lead to further price reductions. Conversely, if supply becomes constrained due to production issues or consolidation among manufacturers, prices could see a temporary increase.
3. Reimbursement Policies: Payer formularies and reimbursement rates set by Medicare, Medicaid, and private insurers play a critical role. Changes in these policies, such as preferred drug lists or co-payment structures, can influence demand and, consequently, pricing.
4. Drug Shortages: While azithromycin is generally available, sporadic drug shortages of APIs or finished products can occur for any medication. If such a shortage impacts azithromycin, prices could spike temporarily. The FDA tracks drug shortages, which can provide early warnings [6].
5. Regulatory Environment: Changes in manufacturing standards or drug approval processes by regulatory bodies like the FDA can affect production costs and market access.
6. Demand Stability: Sustained or growing demand for azithromycin for its primary indications will provide a baseline for pricing. A significant decline in demand, perhaps due to the emergence of more effective or safer alternatives for key indications, would negatively impact pricing.

Price Projections (2024-2027):

Given the mature nature of the azithromycin market and the persistent competitive pressure from multiple generic manufacturers, significant price increases are unlikely.

• Short-Term (2024-2025): Prices for NDC 80610-0115 are expected to remain relatively stable, with marginal fluctuations driven by production costs and minor shifts in competitive dynamics. Any price movements are anticipated to be within a +/- 5% range of current net prices.
• Medium-Term (2026-2027): Continued generic competition will likely exert downward pressure on prices. It is projected that net prices could decrease by an additional 3-7% over this period, particularly if manufacturing efficiencies continue to improve among key suppliers.

Table 2: Azithromycin 250 mg Tablets Price Trend Projection (Net Price)

Period	Projected Price Change	Key Influencing Factors
2024-2025	Stable (+/- 5%)	Production costs, established competition, steady demand
2026-2027	Decreasing (3-7%)	Intensified generic competition, manufacturing efficiencies

It is important to note that these projections are based on current market intelligence and may be subject to change due to unforeseen events such as significant regulatory shifts, major supply chain disruptions, or the development of novel antimicrobial agents that could displace azithromycin for its primary indications.

Regulatory Considerations

The manufacture and distribution of NDC 80610-0115 are governed by strict regulatory frameworks.

• FDA Approval: Aurobindo Pharma Limited, as the manufacturer, must comply with U.S. Food and Drug Administration (FDA) regulations for Current Good Manufacturing Practices (cGMP). This ensures product quality, safety, and efficacy [7].
• Abbreviated New Drug Application (ANDA): Generic drugs like azithromycin are approved through the ANDA pathway, which demonstrates that the generic is bioequivalent to the reference listed drug [8].
• Orange Book: The FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book) lists drugs approved under the Federal Food, Drug, and Cosmetic Act, including azithromycin, and identifies their patent status [9].
• DEA Regulations: While azithromycin is not a controlled substance, manufacturers and distributors must adhere to DEA regulations regarding drug security and preventing diversion, particularly for medications with widespread use.

Adherence to these regulations is non-negotiable and directly impacts a manufacturer's ability to compete and maintain market access. Non-compliance can lead to product recalls, manufacturing shutdowns, and significant financial penalties, all of which would impact supply and pricing.

Intellectual Property Landscape

The originator patent for azithromycin has long expired. Zithromax (Pfizer) was first approved by the FDA in 1991 [10]. This patent expiry opened the door for generic competition, which is the primary driver of the current market structure and pricing dynamics for NDC 80610-0115. There are no active patents on the azithromycin molecule itself that would prevent generic manufacturing. Any remaining intellectual property would likely pertain to specific novel formulations, delivery methods, or manufacturing processes, none of which are currently impeding the generic market for standard azithromycin tablets.

Supply Chain Dynamics

The global supply chain for generic azithromycin involves multiple stages:

1. API Manufacturing: The Active Pharmaceutical Ingredient (API) is typically manufactured in countries with lower production costs, such as India and China.
2. Finished Dosage Form Manufacturing: Aurobindo Pharma Limited manufactures the finished tablets at its approved facilities.
3. Distribution: Finished products are distributed through a network of wholesalers, distributors, and directly to large pharmacy chains or hospital systems.

Potential Supply Chain Vulnerabilities:

• Geopolitical Instability: Events impacting major API manufacturing regions can disrupt supply.
• Logistical Challenges: Shipping delays, port congestion, and increased transportation costs can affect product availability and costs.
• Quality Control Issues: Any lapse in quality control by API suppliers or finished product manufacturers can lead to batch rejections or recalls, impacting supply.
• Regulatory Changes in Manufacturing Hubs: Stricter environmental or manufacturing regulations in countries producing APIs can increase costs or reduce output.

Aurobindo Pharma's ability to manage these risks through diversified sourcing and robust quality assurance protocols will be critical for its market position.

Conclusion

NDC 80610-0115, Azithromycin Tablets, 250 mg, operates in a highly competitive generic pharmaceutical market. Demand remains robust due to the prevalence of bacterial infections and its role in treating STIs. Pricing is expected to remain stable in the short term, with a projected slight decline in the medium term driven by ongoing generic competition and manufacturing efficiencies. Manufacturers must navigate a complex regulatory environment and maintain resilient supply chains to sustain market access and profitability.

Key Takeaways

• NDC 80610-0115 is generic Azithromycin Tablets, 250 mg, manufactured by Aurobindo Pharma Limited.
• Market demand is stable, driven by common bacterial infections and STI treatment.
• Intense generic competition is the primary determinant of current and future pricing.
• Prices are projected to remain stable in the short term (2024-2025) and decrease slightly in the medium term (2026-2027).
• Regulatory compliance and supply chain reliability are critical for market participation.

Frequently Asked Questions

1. What is the primary indication for Azithromycin 250 mg tablets? Primary indications include respiratory tract infections (e.g., pneumonia, bronchitis), skin infections, and sexually transmitted infections (e.g., chlamydia, gonorrhea).

2. How does patent expiry impact the price of NDC 80610-0115? Patent expiry of the originator drug (Zithromax) allowed for the entry of multiple generic manufacturers, leading to significant price reductions and creating a highly competitive market where price is a key differentiator.

3. Are there any anticipated drug shortages for Azithromycin? As of current analysis, there are no widespread, officially designated drug shortages for azithromycin. However, the FDA tracks drug shortages, and any such designation would impact supply and potentially pricing.

4. What is the regulatory pathway for generic azithromycin products like this one? Generic azithromycin products are approved by the FDA via the Abbreviated New Drug Application (ANDA) pathway, which requires demonstrating bioequivalence to the reference listed drug and adherence to Current Good Manufacturing Practices (cGMP).

5. Beyond manufacturing costs and competition, what other factors could significantly influence the price of NDC 80610-0115? Changes in payer reimbursement policies, shifts in clinical guidelines that favor alternative treatments, or disruptions in the global API supply chain due to geopolitical events or stringent regulatory enforcement in manufacturing countries could significantly impact pricing.

Citations

[1] U.S. Food and Drug Administration. (n.d.). National Drug Code Directory. Retrieved from [FDA National Drug Code Directory] (Specific URL not provided for general access, but can be found via FDA.gov search)

[2] Centers for Disease Control and Prevention. (2023, May 11). Respiratory Diseases. Retrieved from https://www.cdc.gov/respiratory-diseases/index.html

[3] U.S. Department of Health and Human Services. (2021, June 14). Sexually Transmitted Infections Treatment Guidelines. Centers for Disease Control and Prevention. Retrieved from https://www.cdc.gov/std/treatment/default.htm

[4] Grand View Research. (2023). Antibiotics Market Size, Share & Trends Analysis Report. Retrieved from [Grand View Research] (Specific report access may require subscription)

[5] Data from various pharmaceutical pricing databases and wholesale distributors (e.g., First Databank, Red Book, etc. - proprietary access required).

[6] U.S. Food and Drug Administration. (n.d.). Drug Shortages. Retrieved from https://www.fda.gov/drugs/drug-shortages

[7] U.S. Food and Drug Administration. (2022, February 10). Current Good Manufacturing Practice (CGMP) Regulations. Retrieved from https://www.fda.gov/drugs/pharmaceutical-manufacturing/current-good-manufacturing-practice-cgmp-regulations

[8] U.S. Food and Drug Administration. (2019, August 14). Generic Drugs. Retrieved from https://www.fda.gov/drugs/generic-drugs/what-abbreviated-new-drug-application-anda

[9] U.S. Food and Drug Administration. (n.d.). Orange Book. Retrieved from https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book

[10] U.S. Food and Drug Administration. (n.d.). Zithromax (azithromycin) Information. Retrieved from [FDA Zithromax Approval Information] (Specific historical approval data readily accessible via FDA's drug database search functionality).