Last updated: February 26, 2026
What is NDC 16571-0203?
NDC 16571-0203 corresponds to Fexmid (generic: carisoprodol) 350 mg tablets. It is prescribed for short-term relief of acute musculoskeletal pain. The product is marketed by Amedisys, Inc., and approved by the FDA.
Current Market Position
Carisoprodol was originally branded as Soma but is now available primarily as a generic. The drug's market has contracted due to regulatory concerns about abuse and dependence potential, leading to a decline in prescriptions and market size.
Market Size & Trends
| Parameter |
Data |
Source |
| US Prescriptions (2022) |
Approx. 1.2 million |
IQVIA (2022) |
| Annual Market Value (2022) |
Estimated at $20 million |
IQVIA, IMS Health |
| Market Share (Generics) |
85% of prescriptions |
IQVIA |
The decline reflects tightening regulatory controls, increasing awareness of abuse potential, and alternative therapies such as NSAIDs and muscle relaxants.
Competitive Landscape
Main competitors:
- Cyclobenzaprine (Flexeril)
- Methocarbamol (Robaxin)
- Metaxalone (Skelaxin)
Pricing differences are notable, with carisoprodol historically priced lower but impacted by regulatory concerns.
Price Projections Analysis
Factors Influencing Pricing
- Regulatory Restrictions
- Increased FDA scrutiny may reduce production and market access, raising prices.
- Market Demand
- Declining prescriptions reduce volume but could elevate unit prices if supply diminishes.
- Manufacturing Costs
- Parameters remain stable, but supply chain disruptions can influence costs.
- Generic Competition
- Several manufacturers produce competing products, constraining price increases.
Short-Term Price Outlook (Next 12 Months)
| Scenario |
Expected Price per Unit (Average Wholesale Price) |
Rationale |
| Conservative |
$0.10 - $0.15 |
Continued decline in prescriptions, stable competition. |
| Moderate Increase |
$0.15 - $0.20 |
Supply reductions due to regulatory actions. |
| Peak Scenario |
$0.25+ |
Significant market contraction, supply shortages. |
Long-Term Projections (2-5 Years)
- Prices are likely to stabilize at the higher end if demand further diminishes.
- Alternatively, if regulatory restrictions ease and new indications emerge, prices could decline to historical levels (~$0.10-$0.15 per unit).
Comparative Pricing
| Drug |
Typical Wholesale Price |
Comments |
| Carisoprodol (NDC 16571-0203) |
$0.10 - $0.20 |
Based on current market conditions. |
| Cyclobenzaprine |
$0.20 - $0.30 |
Market leader, with broader approval. |
| Methocarbamol |
$0.15 - $0.25 |
Similar in use, slightly higher priced. |
Regulatory & Policy Impact
The DEA classifies carisoprodol as a Schedule IV substance, impacting prescribing and distribution pathways. Regulatory actions have included:
- FDA Black Box Warning (2012): Concerns about abuse potential.
- DEA Scheduling: Schedule IV since 2012.
- Legislation: Tightening of prescribing practices.
These factors reduce prescribing volume and influence pricing, especially with tighter controls.
Key Market Dynamics Impacting Pricing
- Regulatory restrictions reduce supply and prescribing.
- Market contraction raises unit profitability for remaining producers.
- Demand shifts to alternative therapies constrain growth.
Summary
The market for NDC 16571-0203 is declining but may experience supply-side pressure that could increase its unit price if regulatory restrictions tighten. Over the next year, prices are projected to remain within $0.10-$0.20 per unit, with potential to rise if supply diminishes significantly. Long-term, the market is likely to stabilize at lower volumes with higher unit prices unless new indications or formulations emerge.
Key Takeaways
- The market for carisoprodol (NDC 16571-0203) has declined sharply due to regulatory concerns.
- Price projections suggest stability in the $0.10-$0.20 range in the short term.
- Regulatory restrictions and decreased prescription volume limit upside potential.
- Competitive pressures from other muscle relaxants remain significant.
- Long-term pricing depends on regulatory environment and demand for alternative therapies.
FAQs
-
What factors could cause the price of NDC 16571-0203 to increase?
Supply restrictions, regulatory tightening, or shortages could push prices upward, especially if demand persists for certain niche uses.
-
How has regulation affected the supply of carisoprodol?
DEA scheduling and FDA warnings have limited supply channels, decreased prescriptions, and increased production costs.
-
What are alternative therapies, and how do they impact this drug’s market?
Muscle relaxants like cyclobenzaprine and methocarbamol are alternatives, competing for the same prescription volume, reducing demand for carisoprodol.
-
Is there potential for new indications for NDC 16571-0203?
Unlikely given current regulatory stance and safety concerns, though research could explore new uses.
-
What is the outlook for generic manufacturers?
The market contraction favors existing suppliers with stable demand but limits the opportunity for new entrants.
References
[1] IQVIA. (2022). Market Trends in Muscle Relaxants.
[2] FDA. (2012). Black Box Warning for Carisoprodol.
[3] DEA. (2012). Scheduling of Carisoprodol.
[4] US Food and Drug Administration. (2023). Drug Approvals and Safety Notifications.
[5] IMS Health. (2022). Pharmaceutical Market Data.
