Last updated: February 21, 2026
What Is NDC 59148-0011?
NDC 59148-0011 corresponds to a specific pharmaceutical product. Based on available information, this NDC code pertains to Fentanyl Citrate Sublingual Tablets, 0.2 mg. This medication is a potent opioid used for pain management, often prescribed to cancer patients or others requiring potent analgesia.
Current Market Presence
Supply Chain and Manufacturing
Major manufacturers of fentanyl sublingual tablets include brands like Abstral (Sun Pharma) and generics produced by multiple generic drug companies. Manufacturing barriers for fentanyl products involve strict regulatory and security standards due to their high abuse potential.
Regulatory Status
The drug is classified as a Schedule II controlled substance under U.S. federal law, impacting distribution and pricing. The FDA approved this formulation in 2011, with ongoing post-market surveillance.
Market Demand Dynamics
Demand is driven by indications for breakthrough pain in opioid-tolerant cancer patients. The use of fentanyl tablets is largely confined to prescription settings with strict guidelines, limiting unauthorized distribution but maintaining stable demand within approved contexts.
Competitive Landscape
| Company |
Product |
Price Range (per unit) |
Market Share |
Key Distribution Channels |
| Sun Pharma (Abstral) |
Fentanyl Sublingual Tab |
$10 - $15 |
~40% |
Hospitals, specialty pharmacies |
| Generic Manufacturers |
Fentanyl Sublingual Tab |
$8 - $14 |
~50% |
Pharmacies, hospitals, online pharmacies |
| Other Branded Generics |
Various |
$8 - $15 |
~10% |
Specialty distributors |
Pricing Trends
Prices for NDC 59148-0011 have remained relatively stable over the past three years, fluctuating within a narrow window ($8-$15 per tablet). This stability is typical for high-demand, tightly regulated controlled substances.
Regulatory and Policy Impact
The reclassification of opioids under tighter control in recent years (e.g., CDC guidelines, state-level restrictions) marginally affected distribution channels and reimbursement policies but did not significantly alter prices.
Price Projections (Next 3-5 Years)
| Year |
Price Range (per unit) |
Key Factors |
Risks |
| 2023 |
$9 - $15 |
Stable demand, regulation stability |
Supply chain disruptions, increased regulation |
| 2024 |
$9 - $15 |
Continued regulation, market saturation |
Policy shifts, synthetic opioid replacements |
| 2025 |
$8 - $14 |
Market saturation, generic competition |
New formulations, tighter control measures |
| 2026 |
$8 - $14 |
Patent/market exclusivity expiring |
New abuse-deterrent formulations |
Projection assumptions include the continuation of current prescribing trends, no major regulatory upheavals, and stable manufacturing costs. Generic competition suppresses high-end pricing potential.
Price Drivers and Market Risks
- Regulatory Environment: Tighter controls limit supply chain flexibility and can increase procurement costs.
- Healthcare Policies: Reimbursement policies influence the final patient cost and insurer interest.
- Abuse Deterrent Technologies: Innovations in abuse-resistant formulations may alter market dynamics, either decreasing demand for current products or pushing prices upward if new formulations command premiums.
- Market Saturation: Overlap with alternative pain management options, including non-opioid alternatives, could reduce overall demand.
Market Volume Estimates
Based on prescription audit data:
- Estimated annual prescriptions for fentanyl sublingual tablets: 12 million units in the U.S.
- Average retail price per tablet: $10.
- Total market value approximates $120 million annually, subject to fluctuations due to regulatory changes.
Conclusion
The NDC 59148-0011 drug's price remains stable, with modest downward pressure mainly from generic competition. The market is constrained by regulatory controls but benefits from consistent demand in specialty pain management. Future pricing hinges on regulatory shifts, technological advancements in abuse deterrence, and broader opioid prescribing trends.
Key Takeaways
- The current retail price per unit ranges between $8-$15, with stability over recent years.
- Market demand centers on specialized pain management, especially in cancer care.
- Competition between brand and generic manufacturers stabilizes prices.
- Regulatory and policy environments are primary price influencers.
- Innovations in abuse deterrence could reshape market dynamics and pricing.
Frequently Asked Questions
1. Will the price of NDC 59148-0011 increase due to new abuse-deterrent formulations?
Potentially. If new formulations are approved and command premium pricing, existing formulations might decline in market share but may see price increases if protections are associated with higher costs.
2. How does regulatory policy affect pricing?
Stricter regulations limit supply channels, potentially raising procurement costs, but also reduce illicit diversion, stabilizing demand. Reimbursement policies influence actual market prices.
3. What is the impact of generic entry on pricing?
Increased generic competition tends to reduce prices, maintaining a narrow range around the lowest available price points.
4. Are there supply risks for this drug?
Yes. Fentanyl is subject to manufacturing and distribution restrictions, which can cause supply chain disruptions or shortages.
5. Could alternative therapies replace fentanyl sublingual tablets?
Yes. Development of non-opioid analgesics and abuse-deterrent formulations could reduce demand.
References
[1] Food and Drug Administration (FDA). (2011). Approval documentation for fentanyl citrate sublingual tablets.
[2] IQVIA. (2022). U.S. prescription trends for opioid products.
[3] CDC. (2020). Opioid prescribing guidelines and regulations.
[4] Wolters Kluwer. (2023). Drug Price forecast models: Opioids.
[5] DEA. (2022). Controlled substance scheduling and regulation updates.
