Last updated: February 25, 2026
What is NDC 00054-4497?
NDC 00054-4497 corresponds to a medication marketed by Alpharma Inc. It is identified as a Schedule III narcotic containing codeine phosphate, typically used in combination with acetaminophen for pain management. The product's primary indication is acute moderate pain relief. It is supplied in tablet form, with strengths generally ranging from 15 mg to 30 mg of codeine.
Market Overview
Current Market Size
The pain management therapeutic area is a $14 billion global market, with approximately 15% attributable to opioid-based combination products. The segment's growth has slowed from prior years due to increasing regulation and the opioid crisis.
Key Competitors
- Tylenol with Codeine (Johnson & Johnson)
- Acetaminophen with Codeine (various generics)
- Other combination opioids such as hydrocodone and oxycodone products
Regulatory Environment
The Drug Enforcement Agency classifies codeine products as Schedule III under the Controlled Substances Act. Recent regulatory trends restrict prescription durations and increase scrutiny of opioid products to curb misuse and abuse.
Current Pricing Landscape
The AWP (Average Wholesale Price) for similar combination products varies:
| Product |
Strength |
Typical AWP per tablet |
Estimated Annual Treatment Cost |
| Tylenol with Codeine #3 |
30 mg/300 mg |
$0.80 |
$290 (based on 30-day supply) |
Generic equivalents often retail at 20–40% lower prices, with AWPs around $0.50–$0.65 per tablet.
Price Projections
Factors Influencing Future Pricing
- Regulatory restrictions: Stricter controls may increase costs related to compliance, distribution, and monitoring.
- Market competition: Increased generic availability tends to drive down prices.
- Prescriber trends: Shift away from opioids to alternative pain therapies reduces demand.
- Potential for abuse: Abuse deterrent formulations could elevate manufacturing costs, potentially increasing retail prices.
Short-term (Next 1–2 Years)
- Price stability expected due to continued generic competition.
- AWP Approximation: $0.45–$0.55 per tablet for generics.
- Annual cost: Approximately $200–$350 for a 30-day supply.
Medium-term (3–5 Years)
- Market contraction risk because of regulation and prescriber behavior.
- Price decline projected for standard formulations; abuse-deterrent formulations may command a premium.
Long-term (Beyond 5 Years)
- Potential for price stabilization or increase if abuse-deterrent formulations are widely adopted.
- Market decline anticipated due to alternative therapies and regulatory restrictions.
Market Entry and Growth Opportunities
- Genericization: Entry as a generic product can achieve rapid market penetration, with potential for 20–30% price reductions.
- Innovation: Developing abuse-deterrent formulations could sustain pricing and market share.
- Regional expansion: Markets in countries with less strict opioid regulations may offer growth opportunities.
Regulatory and Policy Risks
- Increased restrictions on opioid prescribing.
- Stringent scheduling changes or bans.
- Public health campaigns reducing prescription rates.
Summary
NDC 00054-4497 operates in a highly competitive and regulated analgesic market. The product's pricing will likely decline marginally in the near term due to generic competition, with prices stabilizing or increasing if abuse-deterrent formulations are introduced. Market growth remains limited by a shifting focus toward non-opioid therapies.
Key Takeaways
- The global pain management market remains significant but faces regulatory and societal constraints.
- Generic versions dominate pricing, with expected AWPs around $0.45–$0.55 per tablet.
- Abuse-deterrent formulations could influence future price dynamics.
- Market contraction is probable over the medium to long term due to prescriber and legislative shifts.
- Opportunities exist for innovative formulations and geographic expansion in less restrictive regions.
FAQs
1. What is the typical price range for similar combination opioid products?
AWPs for generics range from $0.45 to $0.55 per tablet, with annual treatment costs around $200–$350 for a month’s supply.
2. How will regulatory changes impact pricing?
Increased regulation is expected to restrict access, potentially lowering demand and prices; however, abuse-deterrent formulations may sustain higher prices.
3. What is the market outlook for NDC 00054-4497?
The market faces decline due to regulatory restrictions and shifting prescriber preferences but retains revenue potential through reforms and innovation.
4. How does competition affect pricing?
Generic availability drives prices down; branded products typically command higher fixed pricing, but market share favors generics.
5. Are there growth prospects outside the U.S.?
Yes, countries with less restrictive opioid policies present opportunities, albeit with different regulatory hurdles.
References
[1] IQVIA. (2022). Global and US pain management market report.
[2] U.S. Drug Enforcement Administration. (2022). Controlled Substances Act Scheduling.
[3] Agency for Healthcare Research and Quality. (2021). Prescription opioid use and regulation.
