Last updated: February 16, 2026
What is the drug associated with NDC 00169-4307?
The National Drug Code (NDC) 00169-4307 corresponds to Hydrocodone Bitartrate and Acetaminophen (5 mg/325 mg), manufactured by Mallinckrodt Pharmaceuticals. It is classified as a Schedule II narcotic used for pain management.
Market Landscape
1. Segment Overview:
Hydrocodone-acetaminophen formulations have historically dominated the analgesic market, especially in the United States, due to their efficacy and widespread prescription. As of 2023, this class remains a key component in pain management, despite increasing regulatory scrutiny over opioid use.
2. Market Size & Trends (2020–2023):
- The U.S. prescription volume for hydrocodone-acetaminophen peaked around 2014, with approximately 130 million prescriptions annually, then declined to around 80 million in 2022, driven by legislative measures and alternative pain management protocols.
- The overall market value was approximately $2.6 billion in 2022, representing a decline of approximately 20% since 2014.
- Industry forecasts indicate a continued decrease in volume but stability in pricing, driven by demand in specific patient segments and ongoing regulatory constraints.
3. Regulatory & Legal Factors:
- The Drug Enforcement Administration (DEA) has tightened scheduling and prescribing restrictions.
- The FDA has emphasized opioid reduction strategies, impacting overall market size.
- Some formulations have faced scrutiny over abuse potential, impacting market presence and substitution effects.
4. Competitive Landscape:
- Major manufacturers include Mallinckrodt, Purdue Pharma, and Endo Pharmaceuticals.
- Market shifts favor combination products with abuse-deterrent properties, though their penetration remains limited.
- Generics dominate the market, with brand-name products representing a shrinking share.
Price Projections
1. Current Pricing (2023):
- Average wholesale price (AWP) for a 100-count bottle of 5 mg/325 mg tablets approximates $150–$180.
- Retail prices vary based on insurance coverage, pharmacy pricing, and geographic location, with cash prices around $200–$250 per 100-count bottle.
2. Price Trends:
- Slight decline projected for the next 2–3 years, correlating with volume reduction.
- Wholesale prices are expected to stabilize or decline marginally (approximately 2–4%) annually due to increased generic competition.
3. Price Drivers:
- Regulatory restrictions may limit supply or shift demand toward alternative therapies.
- Patent expirations and the entry of generic competitors typically lower prices over time, though in this case, patent exclusivity expired long ago, with generic versions widely available.
- The ongoing opioid reduction efforts may influence prescriber and patient preferences, impacting pricing.
4. Future Price Estimates (2024–2026):
- Wholesale prices are projected to decline to roughly $140–$160 per 100-count bottle by 2026.
- Consumer prices are expected to follow in a similar range, adjusting for inflation and administrative costs.
- Absent major regulatory shifts or supply constraints, prices are unlikely to rebound to their 2014 peak levels.
Summary of Key Data
| Parameter |
2023 Data |
Projection 2026 Data |
| Prescription volume |
80 million/year |
Slight decline (~70 million/year) |
| Wholesale price per 100 ct |
$150–$180 |
$140–$160 |
| Retail price per 100 ct |
$200–$250 |
$180–$220 |
| Market size |
$1.5 billion |
Slight decline to ~$1.2 billion |
Key Takeaways
- Hydrocodone-acetaminophen remains a significant, though declining, analgesic market segment due to regulatory pressures and shifts toward non-opioid pain treatments.
- Price levels are expected to decrease gradually as generic competition intensifies and prescriber habits evolve.
- Market volume reductions will exert downward pressure on revenue, but stable or marginally declining prices support continued profitability for leading manufacturers.
- Regulatory and legal landscapes will heavily influence market dynamics; shifts in prescribing policies could accelerate decline.
FAQs
1. What factors will most influence the price of NDC 00169-4307 in the coming years?
Regulatory restrictions, prescriber preferences, generic drug penetration, and legal policies aimed at opioid reduction. These factors directly impact supply, demand, and pricing.
2. How does the market for hydrocodone-acetaminophen compare to other analgesics?
It remains one of the most prescribed opioids but faces competition from non-opioid analgesics and alternative therapies. Future growth prospects are limited due to regulatory constraints.
3. Is there potential for new formulations or abuse-deterrent technologies?
Yes, some manufacturers have introduced abuse-deterrent formulations, which can command higher prices but constitute a small share of the overall market.
4. How do patent expirations influence market pricing?
Patent expirations lead to widespread generic competition, driving prices downward. Since hydrocodone-acetaminophen formulations have long faced generic entries, their prices are primarily dictated by competition rather than patent barriers.
5. What alternative therapies could replace hydrocodone-acetaminophen?
Non-opioid analgesics, nerve blocks, physical therapy, and non-pharmacologic pain treatments increasingly substitute opioids, especially in light of regulatory and societal pressures.
References
[1] IMS Health (2022). United States prescription drug market analysis.
[2] FDA. Drug Safety and Availability, Opioid Pain Medications.
[3] IQVIA. 2022 National Prescription Audit.
[4] CDC. Opioid Prescribing Data.
[5] MarketWatch. Pain Management Drug Market Trends, 2020–2023.
