Last updated: March 13, 2026
What is the Drug NDC 00378-4287?
NDC 00378-4287 refers to Hydrocodone-Acetaminophen (5 mg/300 mg), a prescription opioid combined with acetaminophen. It is primarily used for managing moderate to severe pain. It is manufactured by Mallinckrodt Pharmaceuticals under the brand Hycet.
Current Market Position
Hydrocodone-Acetaminophen formulations are among the most prescribed opioid analgesics in the United States. The market volume is driven by pain management needs, prescribing patterns, regulatory policies, and the public health emphasis on opioid misuse mitigation.
Prescribing Trends & Volume
- Prescription Volume (2022): Approximately 80 million prescriptions annually in the U.S. (IQVIA, 2022)
- Market Share: Hydrocodone drugs account for 28% of all opioid prescriptions.
- Key Competitors:
- Norco (AbbVie)
- Vicodin (historic, now replaced by generics)
- Lortab (discontinued but tracked historically)
- Generic hydrocodone-acetaminophen products
Regulatory Landscape
- FDA: Monitoring opioid prescribing trends; efforts to curb misuse through prescribing guidelines.
- DEA: Classifies hydrocodone products as Schedule II controlled substances.
- State Regulations: Vary by state, impacting prescribing volume and access.
Market Size & Revenue
Historical Revenue Data
| Year |
U.S. Market Revenue (USD billions) |
Remarks |
| 2020 |
4.1 |
Slight decline attributed to COVID-19 impact and increased regulations |
| 2021 |
4.3 |
Rebound as elective procedures resumed, steady prescribing |
| 2022 |
4.2 |
Stabilization observed, industry cautious about prescribing patterns |
Pricing Overview
- Average Wholesale Price (AWP): ~$0.17–$0.20 per tablet for generics
- Average Retail Price: $0.30–$0.50 per tablet
- Pack Size: Commonly sold in 30-count bottles
Pricing Trends
- Generic vs. Brand: Generics dominate the market, reducing prices by approximately 60% compared to branded equivalents.
- Policy Impact: Stricter regulations and increased monitoring have limits on prescription duration and volume, impacting revenue.
Price Projections for 2023–2026
Assumptions
- Market demand remains steady, influenced by ongoing pain management needs.
- Generics will continue to dominate market share (>90%).
- Regulatory measures will persist, constraining prescribing volumes.
- Public health policies emphasize opioid non-pharmacologic alternatives, potentially reducing demand marginally.
Estimated Wholesale Price Range
| Year |
Price per Tablet (USD) |
Notes |
| 2023 |
$0.16–$0.19 |
Slight decline expected due to market saturation |
| 2024 |
$0.15–$0.18 |
Potential further decline with increased generics entry |
| 2025 |
$0.14–$0.17 |
Market stabilization at lower price points |
| 2026 |
$0.14–$0.16 |
Continued downward pressure |
Market Revenue Projections
- 2023: ~$850 million
- 2024: ~$800 million
- 2025: ~$750 million
- 2026: ~$700 million
Projection based on unit sales volume (~3.5–4 billion tablets annually) and prevailing prices, considering a 5% annual decline in total volume driven by regulatory controls.
Strategic Implications
- Sales are likely to decline gradually unless new formulations or indications are approved.
- Market entry by abuse-deterrent formulations may command higher prices but is limited to new patent-protected products.
- Distribution channels are highly fragmented, with pharmacies and hospitals as primary points.
Competition & Market Entry
- Generics: Dominant, with multiple manufacturers.
- Branded Products: Limited, as patent exclusivity has expired.
- Emerging Alternatives: Non-opioid analgesics (e.g., NSAIDs, nerve blocks) could reduce future demand.
Key Takeaways
- NDC 00378-4287, a generic hydrocodone-acetaminophen 5/300 mg, has a stable but declining market due to regulatory pressures.
- Average wholesale prices are expected to remain under $0.20 per tablet, with steady volume declines.
- Revenue projections forecast a gradual decrease over the next four years, with total U.S. market revenue falling below $700 million by 2026.
- Market entry barriers are low, but growing regulatory and public health measures limit growth potential.
FAQs
Q1: Will prices for hydrocodone-acetaminophen increase due to shortages?
A: Shortages are unlikely to cause price increases significantly; more often, shortages reduce sales volume.
Q2: Are there opportunities for new formulations of hydrocodone-acetaminophen?
A: Yes, abuse-deterrent formulations may command higher prices but face regulatory hurdles and limited adoption.
Q3: How do regulatory changes affect future market size?
A3: Stricter prescribing guidelines and monitoring will reduce volume, impacting overall market size.
Q4: What are the main drivers of competition?
A4: Price competition among generics, regulatory constraints, and shifts toward non-opioid treatments.
Q5: Is vertical integration a factor in this market?
A: Large pharmacy benefit managers and hospital systems control distribution, influencing pricing and access.
References
[1] IQVIA. (2022). IQVIA Prescription Data.
[2] U.S. Food and Drug Administration. (2023). Narcotics and Controlled Substances.
[3] U.S. Drug Enforcement Administration. (2023). Drug Scheduling.
[4] Centers for Disease Control and Prevention. (2022). Opioid Prescribing Data.
