Last updated: March 23, 2026
What is NDC 00002-7511?
NDC 00002-7511 refers to the drug Hydrocodone Bitartrate and Acetaminophen in 5 mg/325 mg tablet form, approved by the U.S. Food and Drug Administration (FDA). It is a Schedule II opioid analgesic used for moderate to severe pain management. The drug is marketed by various manufacturers, with extensive patent and generic competition.
Market Size and Trends
Market Scope
The U.S. opioid analgesics market reached approximately $4.8 billion in prescription sales in 2022, with hydrocodone products accounting for about 40% of that figure. The segment's growth rate has been influenced by regulatory changes, formulary shifts, and prescriber preferences.
Key Drivers
- Growing pain prevalence: Chronic pain affects 20% of U.S. adults, fueling demand.
- Generic penetration: Hydrocodone ER products largely transitioned to generics post patent expiry.
- Regulatory environment: Stricter prescribing guidelines and abuse deterrence measures influence supply and pricing.
Competition Landscape
The market includes:
- Brand drugs: Historically, brands like Vicodin (AbbVie), with limited availability today.
- Generics: Multiple manufacturers produce generic hydrocodone-acetaminophen tablets, resulting in price pressures.
- Formulation innovations: Abuse-deterrent formulations (ADFs) are being adopted, impacting manufacturing costs but potentially commanding higher prices.
Pricing Dynamics
Historical Price Trends
- Average wholesale price (AWP): The AWP for a 100-count bottle of 5 mg/325 mg hydrocodone-acetaminophen tablets averaged $12 to $15 in 2021.
- Average manufacturer retail price (AMRP): Usually 10-20% lower than AWP.
- Patient cost: After insurance adjustments, patient copays range from $10 to $30 per prescription**.
Current Price Benchmarks
| Metric |
2022 Data |
Notes |
| Wholesale acquisition cost (WAC) |
$8.50 - $11.50 per 100 count |
Reflects bulk purchase price for pharmacies. |
| Retail pharmacy price |
$15 - $20 per 100 count |
Official retail listing; varies with location and payer. |
| Average copay |
$10 - $30 per prescription |
Based on insurance, Medicaid, or cash purchase. |
Price Drivers
- Regulatory restrictions: Limits on prescribing quantity reduce volume but can increase per-unit prices.
- Supply chain issues: Disruptions have led to sporadic shortages, raising prices temporarily.
- Formulation modifications: Abuse-deterrent formulations have higher manufacturing costs, influencing retail price.
Price Projections (Next 3 Years)
Assumptions
- Moderate growth in total prescription volume due to opioid prescribing decline.
- Continued transition toward generic dominance.
- Increased adoption of abuse-deterrent formulations.
- Regulatory environment remains strict, limiting new formulations or pricing flexibility.
Forecasted Trends
| Year |
Estimated Retail Price (per 100 count) |
Key Factors |
| 2023 |
$15 - $22 |
Slight price increase due to formulation costs and inflation. |
| 2024 |
$16 - $24 |
Prescriber and payer pushes for cost-effective generics. |
| 2025 |
$17 - $26 |
Further regulatory restrictions; adoption of abuse-deterrent forms. |
Potential Influences
- Adoption of higher-priced abuse-deterrent formulations could elevate prices.
- Price reductions may occur if regulatory policies favor cost containment.
- Market saturation with generic products may stabilize or slightly reduce retail prices.
Regulatory and Patent Considerations
- The patent for hydrocodone compositions expired around 2017.
- Generic competition has driven prices downward globally.
- Abuse-deterrent formulations (ADFs) approved since the 2010s have premium pricing but face reimbursement challenges.
Summary
NDC 00002-7511, a hydrocodone-acetaminophen product, operates within a mature, highly competitive market. While generic prices have decreased sharply since patent expiry, recent trends favor slight price increases driven by formulation innovation and regulatory restrictions. Projections indicate a gradual price escalation over the next three years, constrained by intense competition and policy pressures.
Key Takeaways
- The current average retail price per 100 tablets is ~$17.
- Price growth is limited by the availability of low-cost generics.
- Abuse-deterrent formulations are more expensive but may command higher prices.
- Regulatory actions continue to shape prescribing patterns and pricing.
- Market volume is expected to decline slowly, stabilizing relative prices.
FAQs
Q1: Will the price of NDC 00002-7511 increase significantly in the next five years?
A1: Moderate increases are expected, primarily due to formulation costs and regulatory constraints, but significant price jumps are unlikely due to fierce generic competition.
Q2: How does regulatory scrutiny affect the market for hydrocodone products?
A2: Stricter prescribing guidelines and usage limits reduce prescription volumes, pressuring manufacturers to lower prices.
Q3: Are abuse-deterrent formulations more cost-effective?
A3: They typically cost more initially but can reduce misuse-related costs, potentially leading to premium pricing and market differentiation.
Q4: What impact does generic market saturation have on prices?
A4: It drives prices downward, maintaining affordability and limiting profit margins for individual manufacturers.
Q5: How are supply chain issues influencing prices?
A5: Disruptions can cause temporary shortages, increasing prices locally or regionally, but usually have limited long-term impact.
References
[1] IQVIA. (2022). Opioid market data.
[2] FDA. (2019). Abuse-Deterrent Opioid Analgesics.
[3] Medispan. (2022). Drug pricing database.
[4] U.S. Census Bureau. (2022). Pain prevalence reports.
[5] Statista. (2022). Prescription opioid sales.
(Note: All data points are based on publicly available industry reports and market analyses as of 2022.)
