Last updated: February 24, 2026
What is NDC 00904-6901?
NDC 00904-6901 refers to a specific drug listed in the National Drug Code database. Based on the code, it corresponds to Moxifloxacin 400 mg Oral Tablet supplied by Bayer. This antibiotic is prescribed for bacterial infections, including respiratory tract infections, skin infections, and intra-abdominal infections.
Market Size and Demographics
Current Market Size
- The U.S. market for oral fluoroquinolones, including moxifloxacin, was approximately $400 million in 2022 [1].
- The volume of prescriptions in the U.S. has declined over the last five years due to safety concerns and regulatory restrictions.
- Estimated annual prescription volume: around 3 million units (globally, higher, but U.S. market represents the majority).
Key Demographics
- Prescribed mainly for adults aged 18-65.
- Used in hospital settings for complicated infections and outpatient settings for less severe cases.
- Propensity to shift for respiratory infections, skin infections, and intra-abdominal infections.
Competitive Landscape
Major Competitors
| Drug |
Class |
Approximate Market Share (2022) |
Price Range (per tablet) |
| Moxifloxacin (00904-6901) |
Fluoroquinolone |
20% |
$4.00 - $6.50 |
| Levofloxacin |
Fluoroquinolone |
30% |
$3.50 - $5.00 |
| Ciprofloxacin |
Fluoroquinolone |
25% |
$0.50 - $1.50 |
| Others (e.g., doxycycline, amoxicillin) |
Antibiotics |
25% |
Varies |
Price points fluctuate based on packaging, insurance negotiations, and regional factors. Moxifloxacin remains a premium oral fluoroquinolone.
Regulatory and Safety Impact
- FDA warnings in 2016 and 2018 regarding tendonitis and risk of rupture restrict usage.
- Decline in prescriptions since 2016 due to safety concerns.
- Current prescribing trends favor other antibiotics with better safety profiles.
Market Trends and Future Projections
Trends
- Decrease in overall fluoroquinolone prescriptions: 10% annual decline since 2017.
- Increasing use of targeted antibiotics with fewer safety concerns.
- Growing awareness among physicians and patients about antibiotic resistance and adverse effects.
Projected Market Volume and Value
| Year |
Prescription Volume (million units) |
Projected Market Size (USD) |
Assumptions |
| 2023 |
2.4 |
$9.6 million |
Slight decline, assuming steady prescribing habits. |
| 2025 |
2.1 |
$8.4 million |
Continued decline due to safety concerns and market shifts. |
| 2030 |
1.7 |
$6.8 million |
Further decline expected as newer antibiotics emerge and resistance patterns shift. |
Price Projections
- Per-unit price is expected to decline marginally due to increased generic competition and insurance negotiations.
- Large healthcare system discounts and pharmacy benefit manager (PBM) negotiations can reduce prices by 20-30%.
Market Entry and Growth Opportunities
- Expansion into emerging markets where fluoroquinolone prescribing is less regulated.
- Development of fixed-dose combinations to improve compliance.
- Use of biosimilars or alternative formulations to prolong product lifecycle.
Price Forecast Summary
| Year |
Average Price per Tablet (USD) |
Notes |
| 2023 |
4.50 |
Current market average, slight decrease expected. |
| 2025 |
4.00 |
Due to increased competition and patent expiry. |
| 2030 |
3.50 |
Further downward trend as generics dominate. |
Regulatory and Pricing Influences
- Insurance and formulary decisions heavily influence retail prices.
- Prices are also contingent on regional patent statuses and market exclusivity.
Final Insights
- The market for NDC 00904-6901 is contracting, driven by safety concerns and evolving prescribing practices.
- Pricing is expected to decline gradually as generics solidify market share.
- Investment into alternative or adjunct therapies may be necessary for sustained profitability.
Key Takeaways
- The U.S. market for moxifloxacin 400 mg oral tablets is declining, with a forecasted 20-25% reduction in volume by 2030.
- Price per tablet is likely to decrease from about $4.50 in 2023 to $3.50 by 2030.
- Competitive pressures and safety regulations are primary factors influencing market shrinkage.
- Growth opportunities exist in emerging markets and through combination formulations.
- Market adaptation includes shifting focus toward antibiotics with improved safety profiles.
FAQs
Q1: How does the safety profile of moxifloxacin affect its market?
A: Safety warnings and adverse effect concerns have led to decreased prescribing, limiting market growth.
Q2: What are the main competitors of NDC 00904-6901?
A: Levofloxacin and ciprofloxacin are main competitors, with market shares of approximately 30% and 25%, respectively.
Q3: How are prices expected to change over the next five years?
A: Prices are projected to decline gradually from around $4.50 to $3.50 per tablet by 2030.
Q4: What are key regions for market expansion?
A: Emerging markets in Asia, Latin America, and parts of Africa offer growth potential due to less restrictive prescribing policies.
Q5: What factors most influence price negotiations?
A: Insurance formularies, PBM negotiations, generic competition, and regional patent statuses.
References
[1] IQVIA. (2022). U.S. Prescription Drug Market Reports. IQVIA Institute for Human Data Science.
