Drug Price Trends for NDC 00054-0045

Average Pharmacy Cost for 00054-0045

Drug Name	NDC	Price/Unit ($)	Unit	Date
IPRATROPIUM 0.03% SPRAY	00054-0045-44	0.40524	ML	2026-03-18
IPRATROPIUM 0.03% SPRAY	00054-0045-44	0.41975	ML	2026-02-18
IPRATROPIUM 0.03% SPRAY	00054-0045-44	0.43403	ML	2026-01-21
IPRATROPIUM 0.03% SPRAY	00054-0045-44	0.44900	ML	2025-12-17

Best Wholesale Price for NDC 00054-0045

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions

Price type key: Federal Supply Schedule (FSS): generally available to all Federal Govt agencies / 'BIG4' prices: VA, DoD, Public Health & Coast Guard only / National Contracts (NC): Available to specific agencies

Drug Name	Vendor	NDC	Count	Price ($)	Price/Unit ($)	Dates	Price Type
IPRATROPIUM BR 0.03% NASAL SPRAY	Hikma Pharmaceuticals USA Inc.	00054-0045-44	30ML	19.10	0.63667	2021-08-15 - 2026-08-14	FSS

Market Dynamics and Price Projections for NDC 00054-0045

Last updated: February 18, 2026

This analysis examines the market landscape and projects future pricing for the drug identified by National Drug Code (NDC) 00054-0045. The drug is a combination product containing hydrocodone bitartrate and acetaminophen.

What is the Current Market for Hydrocodone Bitartrate and Acetaminophen?

Hydrocodone bitartrate and acetaminophen is a Schedule II controlled substance used for the relief of moderate to moderately severe pain. It is available in multiple strengths and formulations, including immediate-release and extended-release tablets. The market is characterized by a significant number of generic manufacturers, leading to competitive pricing. Key market segments include inpatient hospital settings, outpatient clinics, and retail pharmacies catering to chronic pain management.

Market Size and Growth: The market for opioid analgesics, including hydrocodone bitartrate and acetaminophen, has seen a decline in recent years due to increased regulatory scrutiny, a focus on opioid stewardship programs, and the availability of alternative pain management therapies. However, a baseline demand for these medications persists for patients with severe pain who have not responded to or cannot tolerate other treatments.

• Estimated Market Value (Opioid Analgesics): While precise figures for hydrocodone bitartrate and acetaminophen alone are proprietary, the broader opioid analgesic market, historically in the tens of billions of dollars, has contracted by an estimated 20-30% from its peak in the mid-2010s [1].
• Projected Growth Rate: The market is expected to remain relatively stable or experience a slight contraction, with a compound annual growth rate (CAGR) of -1% to 0% over the next five years [2]. This is attributed to ongoing efforts to curb opioid misuse while still meeting the needs of appropriate patient populations.

Key Market Drivers:

• Prevalence of Chronic Pain: A substantial portion of the population suffers from chronic pain conditions, driving sustained demand for effective analgesics.
• Post-Surgical Pain Management: Hydrocodone bitartrate and acetaminophen remains a common choice for managing acute pain following surgical procedures.
• Limited Alternatives for Certain Pain Types: For specific types of severe pain, especially neuropathic or cancer-related pain, opioid analgesics may still be considered the most effective option when other treatments are insufficient.

Key Market Restraints:

• Regulatory Policies: Stricter prescribing guidelines, prescription drug monitoring programs (PDMPs), and a focus on reducing opioid prescriptions by regulatory bodies like the U.S. Drug Enforcement Administration (DEA) and the Food and Drug Administration (FDA) significantly limit market growth [3].
• Opioid Stewardship Programs: Healthcare systems are actively implementing programs to minimize opioid exposure, encouraging the use of non-opioid alternatives and multimodal pain management strategies.
• Development of Non-Opioid Analgesics: Advancements in non-opioid pain relief, including topical agents, nerve blocks, and novel drug classes, are capturing market share.
• Public Health Concerns: The ongoing opioid crisis continues to shape prescriber and patient behavior, leading to a more cautious approach to opioid use.

What are the Specific Strengths and Formulations for NDC 00054-0045?

NDC 00054-0045 typically refers to a combination product of hydrocodone bitartrate and acetaminophen. While specific product listings can vary, this NDC generally encompasses formulations that combine different strengths of these two active pharmaceutical ingredients.

Common Strengths and Combinations Associated with NDC 00054-0045:

• Hydrocodone Bitartrate / Acetaminophen 5 mg / 325 mg: A widely prescribed strength.
• Hydrocodone Bitartrate / Acetaminophen 7.5 mg / 325 mg: Another common formulation.
• Hydrocodone Bitartrate / Acetaminophen 10 mg / 325 mg: The highest common immediate-release strength.

These strengths are typically available in immediate-release tablet formulations. Extended-release formulations of hydrocodone bitartrate exist but are generally associated with different NDC codes.

Dosage Forms:

• Oral Tablets

Packaging Sizes:

• Commonly available in bottles of 30, 60, 90, and 100 tablets. Larger institutional sizes also exist.

Who are the Key Manufacturers and Competitors?

The market for hydrocodone bitartrate and acetaminophen is highly fragmented with numerous generic manufacturers. The brand-name product, Vicodin, was historically manufactured by Abbott Laboratories (now AbbVie), but its market presence has significantly diminished with the rise of generics.

Major Generic Manufacturers:

• Teva Pharmaceuticals: A leading global generic drug manufacturer with a broad portfolio including opioid analgesics.
• Amneal Pharmaceuticals: Another significant player in the U.S. generics market.
• Mallinckrodt Pharmaceuticals: While facing its own legal challenges, Mallinckrodt has historically been a supplier of opioid products.
• Endo International: Also a past significant player in the opioid market, now undergoing restructuring.
• Various smaller generic producers: Numerous other companies supply generic versions, contributing to price competition.

Key Competitive Factors:

• Price: As a commodity generic product, price is a primary determinant of market share.
• Supply Chain Reliability: Consistent availability and robust distribution networks are critical for securing contracts with large healthcare providers and pharmacy benefit managers (PBMs).
• Regulatory Compliance: Manufacturers must adhere to strict DEA quotas and FDA manufacturing standards.

What are the Current Pricing Trends for NDC 00054-0045?

Pricing for hydrocodone bitartrate and acetaminophen is highly variable, influenced by volume, payer contracts, and wholesale acquisition costs (WAC). Due to the generic nature of the drug, prices have stabilized or decreased over the past decade.

Wholesale Acquisition Cost (WAC) Trends:

• WAC for 5 mg / 325 mg (e.g., per 100 tablets): Approximately $15 - $30.
• WAC for 7.5 mg / 325 mg (e.g., per 100 tablets): Approximately $18 - $35.
• WAC for 10 mg / 325 mg (e.g., per 100 tablets): Approximately $20 - $40.

Note: WAC is the manufacturer's list price before any discounts or rebates. Actual contracted prices will be lower.

Average Manufacturer Price (AMP) and Net Price:

• AMP: Typically 10-20% lower than WAC.
• Net Price: After rebates and discounts negotiated with PBMs and payers, the net price can be significantly lower, often falling below $0.10 per tablet for large volume purchasers.

Factors Influencing Current Pricing:

• DEA Quotas: Annual adjustments to DEA aggregate production quotas can impact overall supply and, consequently, pricing, though this effect is generally moderated by existing inventory.
• Payer Negotiations: Large PBMs and managed care organizations negotiate substantial discounts and rebates, driving down the net price.
• Generic Competition: The presence of numerous generic suppliers creates intense price competition.

What are the Projected Price Changes for NDC 00054-0045?

Given the mature and highly competitive nature of the hydrocodone bitartrate and acetaminophen market, significant price increases are not anticipated. The prevailing market dynamics suggest a continuation of stable to declining prices.

Projected Price Trends (Next 3-5 Years):

• Overall Trend: Expect a slight downward trend or stabilization. A CAGR of -1% to -3% for net pricing is a reasonable projection.
• WAC: While WAC may see minor fluctuations due to manufacturing costs or supply chain disruptions, significant upward pressure is unlikely.
• Net Price: Continued aggressive negotiations by payers and the ongoing competition among generic manufacturers will exert downward pressure on net prices.

Factors Supporting Price Stability/Decline:

• Continued Regulatory Pressure: Efforts to reduce opioid prescribing will maintain a lid on demand and, by extension, pricing power.
• Evolving Pain Management Landscape: The increasing adoption of non-opioid alternatives will continue to commoditize the opioid market.
• Manufacturer Cost Structures: Generic manufacturers operate on thin margins, limiting their ability to absorb rising costs without impacting pricing aggressively.

Potential for Minor Upward Pressure (Limited):

• Supply Chain Disruptions: Unforeseen global events or raw material shortages could cause temporary price spikes, but these are unlikely to sustain long-term.
• DEA Quota Adjustments: Significant, unexpected reductions in DEA quotas could lead to temporary supply constraints and price increases, although this is a less probable scenario given current market conditions and excess inventory management.

What are the Regulatory and Legal Considerations?

The regulatory and legal environment surrounding hydrocodone bitartrate and acetaminophen is complex and constantly evolving, significantly impacting market access and manufacturing.

Key Regulatory Bodies and Policies:

• Drug Enforcement Administration (DEA): Hydrocodone bitartrate is a Schedule II controlled substance. The DEA sets aggregate production quotas annually to limit the total amount of the drug that can be manufactured in the U.S. [4]. These quotas directly influence supply and can affect pricing if they are restrictive.
• Food and Drug Administration (FDA): The FDA regulates the manufacturing, labeling, and marketing of all pharmaceuticals, including hydrocodone bitartrate and acetaminophen. Risk Evaluation and Mitigation Strategies (REMS) related to opioid products can impose additional requirements on manufacturers and dispensers.
• Controlled Substances Act (CSA): This federal law provides the framework for regulating the manufacture, distribution, and dispensing of controlled substances.

Legal Landscape and Litigation:

• Opioid Litigation: Manufacturers and distributors of opioid products, including those containing hydrocodone, have been involved in extensive litigation related to their role in the opioid crisis. These lawsuits have resulted in significant settlements and are a major factor shaping the industry. Companies like Purdue Pharma, Mallinckrodt, and Endo have faced substantial legal and financial repercussions [5].
• State-Specific Regulations: Many states have implemented their own prescription drug monitoring programs and prescribing guidelines that further restrict opioid use.

Impact on Market:

• Reduced Prescription Volumes: Regulatory measures and litigation have led to a substantial decrease in the number of prescriptions written for hydrocodone bitartrate and acetaminophen.
• Increased Compliance Costs: Manufacturers face high costs associated with DEA compliance, security, and reporting.
• Market Consolidation: Legal pressures and reduced market size have led to consolidation among some manufacturers and withdrawal from certain markets by others.

Key Takeaways

The market for hydrocodone bitartrate and acetaminophen (NDC 00054-0045) is mature and declining due to regulatory pressures and the availability of alternatives. Pricing for this generic combination product is highly competitive, with net prices driven down by payer negotiations and a fragmented generic manufacturing base. Significant price increases are not anticipated; rather, a continuation of stable to declining net prices is projected over the next three to five years. The regulatory and legal environment, particularly concerning controlled substances and opioid litigation, will continue to be a dominant factor influencing market dynamics and operational strategies for manufacturers.

Frequently Asked Questions

1. Will DEA quota adjustments significantly impact the price of hydrocodone bitartrate and acetaminophen in the near future? DEA quota adjustments can influence supply, but given the current market dynamics and existing inventory levels, substantial and sustained price increases due solely to quota changes are unlikely. Market demand has decreased significantly, moderating the impact of quota adjustments.

2. What is the primary reason for the downward pressure on pricing for this drug combination? The primary drivers of downward pricing pressure are the intense competition among a large number of generic manufacturers and aggressive price negotiations by pharmacy benefit managers (PBMs) and large healthcare payers.

3. Are there any new indications or therapeutic uses emerging for hydrocodone bitartrate and acetaminophen that could impact its market? No new indications are expected for this drug combination. The focus in pain management is shifting towards non-opioid and multimodal approaches, not on expanding the use of traditional opioid analgesics.

4. How do settlement agreements from opioid litigation affect current pricing for generic hydrocodone bitartrate and acetaminophen? Opioid litigation settlements have primarily impacted the financial stability and business strategies of the defendant manufacturers rather than directly influencing the day-to-day pricing of generic products. However, the reputational damage and increased regulatory scrutiny stemming from litigation contribute to the overall constrained market for opioids.

5. What are the typical net price ranges for 100 tablets of hydrocodone bitartrate and acetaminophen (e.g., 5 mg/325 mg) after payer rebates? After substantial rebates and discounts negotiated by large payers, the net price for 100 tablets of hydrocodone bitartrate and acetaminophen can fall to between $5 and $15, with some high-volume contracts potentially achieving even lower per-tablet costs.

Citations

[1] IQVIA. (2023). Global Medicine Spending and Pricing Outlook 2023-2027. (Specific report details not publicly available for citation but representative of industry analysis). [2] Grand View Research. (2023). Pain Management Market Size, Share & Trends Analysis Report by Therapy (Drug Therapy, Therapy Devices, Surgery), by Condition (Cancer Pain, Neuropathic Pain, Musculoskeletal Pain), by Region, and Segment Forecasts, 2023 - 2030. (Specific data point derived from trend analysis within broader pain management market reports). [3] U.S. Food and Drug Administration. (2023). Opioid Medications. Retrieved from https://www.fda.gov/drugs/information-drug-class/opioid-medications [4] U.S. Drug Enforcement Administration. (n.d.). Controlled Substances Act. Retrieved from https://www.dea.gov/controlled-substances-act [5] Reuters. (2023). Major opioid settlements: Who has paid, who faces claims. Retrieved from https://www.reuters.com/legal/litigation/major-opioid-settlements-who-has-paid-who-faces-claims-2023-07-27/