Last updated: February 23, 2026
What is NDC 00074-0554?
NDC 00074-0554 refers to a specific formulation of a pharmaceutical product, identified by the National Drug Code (NDC) number. This code corresponds to a branded or generic drug, typically available through retail pharmacy channels. Based on available data, this NDC is associated with Xylocaine (lidocaine) 2% Injection.
Market Landscape
Therapeutic Area
Lidocaine 2% injection is used as a local anesthetic for procedures requiring infiltration or nerve block. It competes in the anesthetic market alongside other local anesthetics like bupivacaine and ropivacaine.
Market Size (2022-2023)
- Global Market: Estimated at USD 1.2 billion in 2022.
- United States Market: Approximate value USD 600 million in 2022.
- Growth Rate: Compound annual growth rate (CAGR) of 4% projected through 2028, driven by increasing elective procedures and expanding healthcare infrastructure.
Major Market Players
- AstraZeneca (Xylocaine)
- Hikma Pharmaceuticals
- Teva Pharmaceuticals
- Pfizer
- Mylan (now part of Viatris)
Distribution Channels
- Hospital pharmacies
- Outpatient clinics
- Retail pharmacies
Regulatory Status
- Approved by the FDA since 1948.
- Available via traditional prescription pathways.
- No recent major regulatory changes affecting approval status.
Price Dynamics and Historical Trends
Pricing Data (2022-2023)
| Source |
Average Wholesale Price (AWP) |
Estimated Retail Price |
Notes |
| Red Book (2022) |
USD 25.00 per 10 mL vial |
USD 38.00 per vial |
Standard cost in hospitals and clinics |
| Medi-Span (2023) |
USD 22.50 per 10 mL vial |
USD 34.00 per vial |
Reflects generic and branded averages |
| Medicaid/Medicare |
USD 16.00 per 10 mL vial |
USD 24.00 per vial |
Negotiated pricing for government programs |
Price Trends
- Slight decline in wholesale prices over 2022-2023, correlating with increased generic competition.
- Retail prices remain stable despite wholesale fluctuations, influenced by supply chain costs and hospital formulary decisions.
- Price sensitivity observed in outpatient settings, where institutions prefer cost-effective generics.
Market Outlook and Projections
Short-Term Projections (2024-2025)
- Wholesale prices expected to remain within USD 20-25 per 10 mL vial.
- Retail prices projected to stay in the USD 35-40 range.
- Market share for branded Xylocaine stabilizes at approximately 60%; generics continue gaining ground.
Long-Term Projections (2026-2030)
- Price reduction trajectory forecasted at 1-3% annually owing to genericization and increased competition.
- Market expansion driven by procedural volume growth; estimates suggest 3-5% annual increase in demand.
- Integration of biosimilar and alternative anesthetic agents may pressure prices downward.
Potential Price Influences
- Policy changes favoring cost-effective treatments.
- Supply chain disruptions potentially increasing prices temporarily.
- Patent office decisions on related formulations influencing market stability.
Competitive Strategies
- Manufacturers push for formulary inclusion through pricing discounts.
- Adoption of value-based purchasing agreements.
- Development of new formulations (e.g., extended-release versions) to differentiate products.
Summary
NDC 00074-0554, representing lidocaine 2% injection, operates within a mature, competitive market with steady demand growth. Despite minor price reductions driven by generic entry, the product maintains a stable revenue foundation. Expect wholesale prices to hover around USD 20-25 per 10 mL vial over the next two years, with retail prices holding steady or slightly decreasing.
Key Takeaways
- The market size for lidocaine injections exceeds USD 1 billion globally.
- Price competition has led to slight declines in wholesale costs but stable retail pricing.
- Long-term price decline forecasted at 1-3% annually due to increasing generics.
- Market growth driven by procedural demand, with a CAGR of around 4%.
- Strategic focus for manufacturers includes formulary positioning and development of differentiated formulations.
FAQs
1. What factors influence the price of lidocaine 2% injection?
Pricing is affected by generic competition, supply chain costs, healthcare policy changes, and procurement negotiations.
2. How significant is generic competition for this drug?
Generics hold approximately 40% market share, with pricing pressures leading to declining wholesale prices.
3. Are there any upcoming regulatory changes that could impact pricing?
No major regulatory changes are anticipated soon; however, policy shifts toward cost containment could influence future pricing.
4. What is the outlook for market growth in the next five years?
Market growth is projected at 3-5% annually, driven by increasing procedural volume and healthcare infrastructure expansion.
5. How does the pricing of lidocaine compare internationally?
Pricing varies globally; developed markets tend to have higher prices due to regulatory, supply, and healthcare system differences.
References
[1] IQVIA. (2022). Pharmaceutical Market Data.
[2] Red Book. (2022). Average Wholesale Prices.
[3] Medi-Span. (2023). Drug Pricing Data.
[4] Statista. (2023). Global Local Anesthetic Market Overview.
[5] U.S. Food and Drug Administration. (2022). Drug Approvals and Regulatory Updates.
