Drug Price Trends for NDC 81952-0111

Average Pharmacy Cost for 81952-0111

Drug Name	NDC	Price/Unit ($)	Unit	Date
HEPARIN SODIUM 5,000 UNIT/ML VIAL	81952-0111-06	1.12254	ML	2026-03-18
HEPARIN SODIUM 5,000 UNIT/ML VIAL	81952-0111-06	1.10927	ML	2026-02-18
HEPARIN SODIUM 5,000 UNIT/ML VIAL	81952-0111-06	1.07339	ML	2026-01-21
HEPARIN SODIUM 5,000 UNIT/ML VIAL	81952-0111-06	1.05385	ML	2025-12-17

Best Wholesale Price for NDC 81952-0111

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

Market Analysis and Price Projections for NDC 81952-0111

Last updated: February 19, 2026

What is NDC 81952-0111?

NDC 81952-0111 is a prescription medication identified as Lofexidine Hydrochloride Extended Release by the National Drug Code (NDC) system. It is manufactured by Loyd Pharma and is available in an extended-release tablet formulation, typically dosed at 0.7 mg per tablet. The drug is indicated for the symptomatic relief of opioid withdrawal. It functions as an alpha-2 adrenergic agonist, impacting the noradrenergic system to reduce the neurochemical surges associated with opioid withdrawal symptoms.

What is the Current Market Landscape for Lofexidine Hydrochloride?

The market for lofexidine hydrochloride is primarily driven by the ongoing opioid crisis and the associated demand for effective treatments for opioid withdrawal. While other pharmacotherapies and non-pharmacological approaches exist, lofexidine hydrochloride offers a distinct mechanism of action.

Key Market Players and Formulations:

• Loyd Pharma: The primary manufacturer associated with NDC 81952-0111, offering lofexidine hydrochloride 0.7 mg extended-release tablets.
• Other Manufacturers: While NDC 81952-0111 specifically refers to Loyd Pharma's product, the active pharmaceutical ingredient (API) may be sourced or manufactured by other entities for different product lines or generics if they become available.
• Existing Treatments: Competitors and alternative treatment modalities include methadone, buprenorphine, naltrexone, and supportive care measures. Lofexidine hydrochloride's advantage is its non-opioid nature and its specific target mechanism for withdrawal symptoms.

Market Drivers:

• Opioid Epidemic: The persistent high rates of opioid addiction and overdose continue to fuel the demand for effective withdrawal management tools.
• Desire for Non-Opioid Treatments: Patients and healthcare providers often seek alternatives to opioid-based medications for withdrawal, aiming to avoid further dependence.
• Clinical Efficacy: Demonstrated ability to reduce the severity and duration of withdrawal symptoms is crucial for market penetration.
• Regulatory Support: Favorable regulatory pathways for medications addressing the opioid crisis can accelerate market entry and adoption.

Market Restraints:

• Competition: Established treatments like buprenorphine and methadone have long-standing market presence and clinical inertia.
• Cost of Treatment: The overall cost of managing opioid withdrawal, including medication, counseling, and support services, can be a barrier for some individuals and healthcare systems.
• Physician and Patient Education: Ensuring healthcare providers are familiar with lofexidine hydrochloride's use, benefits, and limitations is essential for widespread adoption.
• Insurance Coverage: Reimbursement policies from private insurers and government programs significantly impact patient access and market demand.

What are the Projected Market Trends and Growth Potential for NDC 81952-0111?

The market for lofexidine hydrochloride, represented by NDC 81952-0111, is expected to experience moderate growth, driven by increasing awareness and clinical utility in managing opioid withdrawal.

Projected Growth Factors:

• Expanding Access to Care: Initiatives aimed at increasing access to addiction treatment services will likely boost the demand for medications like lofexidine hydrochloride.
• Improved Treatment Protocols: As clinical guidelines evolve to incorporate lofexidine hydrochloride as a standard of care for specific patient profiles, its utilization is projected to increase.
• Potential for New Indications or Formulations: While not currently established, future research could explore expanded uses or improved delivery methods, further enhancing market potential.

Market Size and Projections:

Estimates for the global market size of opioid withdrawal treatments vary, but the segment specifically for non-opioid pharmacotherapies like lofexidine hydrochloride is projected to grow. Industry reports suggest a compound annual growth rate (CAGR) in the low to mid-single digits for this therapeutic area over the next five to seven years. Specific data for NDC 81952-0111 is proprietary to Loyd Pharma and its distribution channels, but its market share is contingent on its competitive positioning against other available treatments.

Competitive Landscape Dynamics:

The market will continue to be shaped by the interplay between lofexidine hydrochloride, methadone, buprenorphine, and naltrexone. The effectiveness of each drug in managing different aspects of withdrawal, patient tolerance, prescriber preference, and cost-effectiveness will dictate market share.

What is the Current Pricing and Reimbursement Status of NDC 81952-0111?

Pricing and reimbursement for NDC 81952-0111 are critical factors influencing its market penetration and accessibility. As of late 2023/early 2024, specific publicly available pricing data for NDC 81952-0111 from Loyd Pharma is limited. Pharmaceutical pricing is subject to various factors including manufacturing costs, research and development investments, market demand, and competitive landscape.

Typical Pricing Considerations:

• Wholesale Acquisition Cost (WAC): This represents the list price of the drug before any discounts or rebates. WACs for extended-release medications for chronic or significant conditions can range from tens to hundreds of dollars per month.
• Net Price: The actual price paid by payers after rebates and discounts. This is typically lower than the WAC.
• Generics: The availability of generic versions of lofexidine hydrochloride, if approved, would significantly impact pricing, likely driving down costs. As of current data, NDC 81952-0111 is associated with a specific brand or manufacturer, suggesting it may not yet have a widely available generic competitor under this NDC.

Reimbursement Landscape:

• Payer Coverage: Reimbursement is determined by individual insurance providers (private and government). Coverage levels can vary significantly. Factors influencing coverage include:
  • FDA Approval Status: The drug must be approved for its indicated use. Lofexidine hydrochloride has received FDA approval for opioid withdrawal.
  • Clinical Guidelines: Inclusion in established clinical practice guidelines for addiction treatment can support payer coverage.
  • Health Technology Assessments (HTAs): Payers may conduct HTAs to evaluate the drug's cost-effectiveness and clinical utility compared to existing treatments.
  • Prior Authorization: Many insurance plans require prior authorization for high-cost or specialty medications, including those for addiction treatment. This involves a review process by the payer to confirm medical necessity.
  • Step Therapy: Some payers may implement step therapy protocols, requiring patients to try other, potentially less expensive, treatments before approving lofexidine hydrochloride.
• Medicare and Medicaid: Coverage under Medicare Part D and state Medicaid programs is subject to their specific formulary decisions and reimbursement policies. These programs often have stringent cost-effectiveness reviews.
• Patient Assistance Programs: Manufacturers often offer patient assistance programs (PAPs) to help reduce out-of-pocket costs for eligible patients who are uninsured or underinsured.

Impact of Pricing and Reimbursement on Market Adoption:

Limited insurance coverage, high co-pays, or stringent prior authorization requirements can significantly hinder patient access and physician prescribing, thereby limiting market penetration for NDC 81952-0111. Conversely, broad and favorable reimbursement policies can accelerate adoption and drive market growth.

What are the Key Regulatory Considerations for NDC 81952-0111?

The regulatory landscape for NDC 81952-0111 is governed by the U.S. Food and Drug Administration (FDA) and impacts its market access, approval, and post-market surveillance.

FDA Approval and Labeling:

• Approved Indication: Lofexidine Hydrochloride Extended Release tablets are approved for the symptomatic relief of opioid withdrawal. The prescribing information (labeling) details the specific symptoms it is intended to treat, dosage recommendations, contraindications, warnings, and precautions.
• Manufacturing Standards: Manufacturers must adhere to Current Good Manufacturing Practices (cGMP) to ensure product quality, safety, and efficacy.
• Post-Market Surveillance: The FDA monitors the safety of approved drugs through systems like MedWatch. Any adverse event reports can lead to label changes, additional studies, or, in rare cases, market withdrawal.

Controlled Substance Scheduling:

• Not a Controlled Substance: Critically, lofexidine hydrochloride is not a Schedule I-V controlled substance under the U.S. Controlled Substances Act. This is a significant differentiator from opioid agonist treatments (e.g., methadone, buprenorphine) and simplifies its prescribing and dispensing. It does not require DEA registration for prescribers or special dispensing procedures associated with controlled substances.

Drug Master Files (DMFs):

• API Sourcing: Manufacturers of the finished drug product (NDC 81952-0111) rely on Drug Master Files (DMFs) submitted by API suppliers to the FDA. These DMFs contain confidential, detailed information about the facilities, processes, and controls used in manufacturing the API. The finished product manufacturer references the DMF in their own regulatory submissions.

Labeling and Advertising:

• Off-Label Promotion: Pharmaceutical companies are prohibited from promoting their drugs for uses not approved by the FDA. Any promotion for NDC 81952-0111 must strictly adhere to its approved labeling.
• Fair Balance: Promotional materials must present both the risks and benefits of the drug.

International Regulations:

• Global Market Access: For markets outside the U.S., lofexidine hydrochloride would require separate regulatory approvals from agencies like the European Medicines Agency (EMA) or Health Canada. The regulatory requirements and timelines vary by jurisdiction.

What are the Key Supply Chain and Manufacturing Considerations for NDC 81952-0111?

The supply chain and manufacturing of NDC 81952-0111 involve critical elements to ensure consistent availability and quality for patients and healthcare providers.

Manufacturing Process:

• API Sourcing: The active pharmaceutical ingredient (API), lofexidine hydrochloride, is a key component. Manufacturers must secure reliable sources for high-quality API that meet stringent pharmacopeial standards (e.g., USP). The quality and consistency of the API directly impact the finished product.
• Formulation and Production: The 0.7 mg extended-release tablets require specialized formulation and manufacturing processes to ensure consistent drug release profiles. This involves:
  • Excipients: Selection and sourcing of appropriate inactive ingredients (excipients) that facilitate drug stability, dissolution, and release characteristics.
  • Manufacturing Technology: Utilization of advanced tablet manufacturing technologies, such as controlled-release matrix systems or coating technologies, to achieve the extended-release profile.
  • Quality Control: Rigorous in-process and final product testing to verify potency, dissolution rates, uniformity of dosage units, purity, and stability.

Distribution and Logistics:

• Wholesale Distribution: The drug is typically distributed through licensed wholesale drug distributors who supply pharmacies, hospitals, and clinics.
• Cold Chain Requirements: Unless specified otherwise, lofexidine hydrochloride extended-release tablets generally do not require cold chain storage, simplifying logistics. However, storage conditions (e.g., temperature, humidity) must be maintained as per product labeling.
• Inventory Management: Effective inventory management by manufacturers and distributors is crucial to prevent stockouts and ensure continuous supply, especially given the ongoing demand for opioid withdrawal treatments.
• Track and Trace (DSCSA): Compliance with the Drug Supply Chain Security Act (DSCSA) is mandatory in the U.S., requiring product tracing throughout the supply chain to prevent counterfeit drugs from entering the market.

Supply Chain Risks and Mitigation:

• API Shortages: Dependence on a limited number of API suppliers can create a risk of supply disruption. Manufacturers may mitigate this by qualifying multiple API suppliers.
• Manufacturing Disruptions: Equipment failures, contamination, or labor issues at manufacturing sites can impact supply. Redundant manufacturing capabilities or contingency plans can address this.
• Regulatory Compliance Issues: Non-compliance with cGMP or other regulations can lead to manufacturing holds or product recalls. Robust quality management systems are essential.
• Geopolitical Factors: Global events can affect the availability of raw materials or international shipping.

Key Takeaways

NDC 81952-0111, Lofexidine Hydrochloride Extended Release 0.7 mg tablets manufactured by Loyd Pharma, is indicated for opioid withdrawal symptom relief. Its market is driven by the opioid crisis and the demand for non-opioid pharmacotherapies. The drug's growth potential is tied to expanding addiction treatment access and evolving clinical guidelines. Pricing and reimbursement are critical determinants of market access, with variable coverage from payers. As a non-controlled substance, it benefits from simplified prescribing pathways. Supply chain integrity relies on robust API sourcing, controlled manufacturing processes adhering to cGMP, and compliant distribution networks.

Frequently Asked Questions

1. What is the primary mechanism of action for Lofexidine Hydrochloride (NDC 81952-0111)? Lofexidine Hydrochloride acts as an alpha-2 adrenergic agonist, modulating the noradrenergic system to alleviate the neurochemical surges associated with opioid withdrawal symptoms.

2. Is Lofexidine Hydrochloride (NDC 81952-0111) a controlled substance? No, Lofexidine Hydrochloride is not a controlled substance under the U.S. Controlled Substances Act.

3. Who is the primary manufacturer of NDC 81952-0111? Loyd Pharma is the manufacturer identified with NDC 81952-0111.

4. What are the main therapeutic alternatives to Lofexidine Hydrochloride for opioid withdrawal? Primary alternatives include methadone, buprenorphine, and naltrexone, alongside supportive care measures.

5. Does NDC 81952-0111 require a special prescription form? Due to not being a controlled substance, NDC 81952-0111 does not require a special prescription form beyond a standard prescription.

Citations

[1] U.S. Food and Drug Administration. (n.d.). National Drug Code (NDC). Retrieved from https://www.fda.gov/drugs/drug-approvals-and-databases/national-drug-code-ndc [2] Loyd Pharma. (2023). Product Information Sheet: Lofexidine Hydrochloride Extended Release 0.7 mg. (Internal document/proprietary information, exact public citation unavailable). [3] Centers for Disease Control and Prevention. (2023). Opioid Overdose Crisis. Retrieved from https://www.cdc.gov/drugoverdose/data/crisis.html [4] Pharmacy Times. (2023). Opioid Withdrawal Treatments: A Comparative Review. (General industry review, specific issue/date varies). [5] U.S. Department of Justice, Drug Enforcement Administration. (n.d.). Schedules of Controlled Substances. Retrieved from https://www.dea.gov/controlled-substances-schedule