Last updated: March 13, 2026
What Is the Drug Associated with NDC 00168-0267?
NDC 00168-0267 refers to Oxycodone Hydrochloride Extended-Release (ER). It is a schedule II opioid pain medication primarily used for managing moderate to severe pain over long periods, typically in chronic pain patients requiring around-the-clock relief.
Market Overview
Key Market Drivers:
- Rising prevalence of chronic pain conditions.
- Increasing opioid prescriptions in pain management.
- Limited availability of alternative therapies for severe pain.
- Regulatory landscape influencing supply and pricing.
Competitive Landscape:
- Major manufacturers include Purdue Pharma, Teva Pharmaceuticals, and Mallinckrodt.
- Generic versions dominate the formulary, contributing to price competition.
- Nearly 70 registered producers manufacture oxycodone ER, with variations in formulation and pricing.
Regulatory Environment:
- The DEA controls production quotas for oxycodone.
- The DEA and FDA enforce strict monitoring to mitigate abuse.
- Recent reforms aim to limit prescribing for non-medical use.
Distribution Channels:
- Hospitals and clinics uptake the drug for inpatient and outpatient care.
- Pharmacies serve as primary dispensing points.
- Limited online or direct-to-consumer distribution.
Price Trends and Projections
Historical Pricing Data (2020–2022):
| Year |
Average Wholesale Price (AWP) per 30mg IR tablet |
Average Transaction Price (ATP) per 30mg IR tablet |
| 2020 |
$0.50 |
$0.45 |
| 2021 |
$0.55 |
$0.50 |
| 2022 |
$0.60 |
$0.55 |
Note: These prices are for immediate-release formulations. Extended-release variants typically retail at 20%–50% higher prices per unit.
Price Drivers:
- Increased generic competition reduces per-unit price.
- Heightened regulation and monitoring can increase distribution costs.
- Supply fluctuations due to quota adjustments influence pricing.
Current Market Price (Q1 2023):
- Average wholesale price approximates $0.65–$0.70 per 30mg ER tablet.
- Reimbursement rates for insurers generally range from $0.70–$0.80.
Future Price Projection (Next 12–24 Months):
- Prices are expected to stabilize or decline marginally by 5–10%, driven by:
- Increased generic penetration.
- Regulatory efforts curbing diversion.
- Market saturation in certain regions.
- Prices could outperform expectations if new formulations or abuse-deterrent technologies are introduced, adding a premium of 10–15%.
Factors Potentially Impacting Prices:
- Policy shifts targeting opioid prescribing can restrict volume, lowering overall revenue.
- Legal actions against manufacturers for opioid-related lawsuits could influence production costs.
- Development of abuse-deterrent formulations may command premium pricing, but harm to volume could offset gains.
Investment and R&D Outlook:
- Increased focus on abuse-resistant formulations.
- Potential for biosimilar or novel delivery systems.
- Market interest remains cautious due to regulatory and legal uncertainties.
Key Takeaways
- NDC 00168-0267 corresponds to oxycodone hydrochloride ER.
- The drug’s market relies heavily on generic competition, with stable price trends over recent years.
- Current average wholesale price per 30mg tablet is around $0.65–$0.70.
- Prices are forecasted to decline slightly, with possible premiums for new abuse-deterrent formulations.
- Regulatory and legal factors heavily influence supply, price, and future market dynamics.
Frequently Asked Questions
1. How does NDC 00168-0267 compare to other opioid pain medications?
It is priced similarly to other extended-release opioids, with prices influenced by formulation, brand vs. generic status, and regulatory controls.
2. What are the main risks affecting the price of this drug?
Legal liabilities, regulatory restrictions, supply chain disruptions, and shifts in prescribing habits all impact pricing stability.
3. Are there upcoming regulatory changes that could affect this drug's market?
Yes, ongoing reforms target prescription monitoring, abuse prevention, and quota limits which could influence supply and pricing.
4. What is the outlook for new formulations of oxycodone ER?
Abuse-deterrent formulations are increasingly in development and could attract a price premium if approved and adopted.
5. How does market saturation impact pricing for NDC 00168-0267?
High market saturation with generic products generally leads to downward pressure on unit prices.
References
[1] U.S. Food and Drug Administration (FDA). (2022). Controlled Substance Schedule. https://www.fda.gov
[2] IQVIA. (2022). Pharmaceutical Market Data & Analytics.
[3] MedPro Drugs. (2022). Pricing and Market Trends for Opioids. https://medprodrugs.com
[4] Drug Enforcement Administration (DEA). (2022). Supply and Quota Reports. https://dea.gov
