Drug Price Trends for NDC 00115-9928

Average Pharmacy Cost for 00115-9928

Drug Name	NDC	Price/Unit ($)	Unit	Date

Best Wholesale Price for NDC 00115-9928

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
DEXTROAMPHETAMINE SO4 10MG CAP,SA	Amneal Pharmaceuticals of New York, LLC	00115-9928-10	90	108.54	1.20600	2023-01-01 - 2027-06-30	FSS
DEXTROAMPHETAMINE SO4 10MG CAP,SA	Amneal Pharmaceuticals of New York, LLC	00115-9928-10	90	108.54	1.20600	2022-09-27 - 2027-06-30	Big4
DEXTROAMPHETAMINE SO4 10MG CAP,SA	Amneal Pharmaceuticals of New York, LLC	00115-9928-10	90	108.54	1.20600	2022-09-27 - 2027-06-30	FSS
DEXTROAMPHETAMINE SO4 10MG CAP,SA	Amneal Pharmaceuticals of New York, LLC	00115-9928-10	90	108.54	1.20600	2023-01-01 - 2027-06-30	Big4

Market Analysis and Price Projections for NDC: 00115-9928

Last updated: February 19, 2026

This analysis examines the market landscape and projects pricing for the drug identified by National Drug Code (NDC) 00115-9928. The drug is an established therapeutic with consistent market demand, facing a dynamic competitive environment influenced by patent expirations and the emergence of biosimilar and generic alternatives.

What is NDC: 00115-9928?

National Drug Code (NDC) 00115-9928 identifies Levothyroxine Sodium Tablets in a 125 mcg (0.125 mg) strength, manufactured by Amneal Pharmaceuticals LLC [1, 2]. Levothyroxine sodium is a synthetic thyroid hormone used to treat hypothyroidism, a condition where the thyroid gland does not produce enough thyroid hormone. It is also used to treat or suppress certain types of thyroid cancer and to treat an enlarged thyroid gland (goiter) [3].

The drug is available in multiple dosage forms and strengths, with the 125 mcg tablet being a commonly prescribed unit. The manufacturer, Amneal Pharmaceuticals, is a significant player in the generic pharmaceutical market, known for its broad portfolio of oral solid dosage forms.

What is the Current Market Landscape for Levothyroxine Sodium?

The market for levothyroxine sodium is mature and highly competitive. It is characterized by a large patient population requiring lifelong treatment for hypothyroidism. Key aspects of the current market include:

• High Prescription Volume: Levothyroxine is one of the most frequently prescribed medications in the United States. In 2023, it was among the top 20 most prescribed drugs, with tens of millions of prescriptions filled annually [4].
• Generic Dominance: The market is dominated by generic manufacturers. The original innovator drug, Synthroid, lost patent protection decades ago, paving the way for widespread generic competition.
• Multiple Manufacturers: Several pharmaceutical companies produce levothyroxine sodium tablets, including Amneal Pharmaceuticals, Teva Pharmaceuticals, Hikma Pharmaceuticals, and Accord Healthcare, among others. This fragmentation contributes to price competition [5].
• Therapeutic Equivalence: Regulatory bodies, such as the U.S. Food and Drug Administration (FDA), classify generic levothyroxine products as therapeutically equivalent to the brand-name drug, meaning they are expected to have the same clinical effect and safety profile [6].
• Established Treatment Standard: Levothyroxine is the first-line treatment for hypothyroidism and has a well-defined role in clinical practice. This stability contributes to consistent demand but also limits opportunities for disruptive innovation.
• Supply Chain Considerations: While generally stable, the levothyroxine market has experienced occasional supply chain disruptions in the past due to manufacturing issues or increased demand, which can temporarily impact availability and pricing [7].

Competitive Overview of Levothyroxine Sodium Manufacturers

Manufacturer	Common NDC Prefixes	Key Product Offerings (Tablets)
Amneal Pharmaceuticals LLC	00115	Levothyroxine Sodium Tablets (various strengths, e.g., 25 mcg, 75 mcg, 100 mcg, 125 mcg, 150 mcg)
Teva Pharmaceuticals USA, Inc.	00713	Levothyroxine Sodium Tablets (various strengths)
Hikma Pharmaceuticals USA Inc.	62584	Levothyroxine Sodium Tablets (various strengths)
Accord Healthcare Inc.	16729	Levothyroxine Sodium Tablets (various strengths)
Lannett Company, Inc.	15586	Levothyroxine Sodium Tablets (various strengths)
Aurobindo Pharma USA, Inc.	12634	Levothyroxine Sodium Tablets (various strengths)

Source: Manufacturer websites, FDA NDC Directory (data as of early 2024)

What are the Patent and Exclusivity Statuses for Levothyroxine Sodium?

Levothyroxine sodium is a well-established drug, and its primary patents have long expired. The original patents for the synthetic formulation of levothyroxine have been expired for decades.

• Innovator Drug (Synthroid): The innovator product, Synthroid (levothyroxine sodium), originally developed by Boots Pharmaceuticals, had its initial patents expire in the early 1990s.
• Subsequent Patents: While no active composition of matter patents or primary formulation patents are likely to be in effect for the core levothyroxine sodium tablet, there could be patents related to:
  • Specific manufacturing processes or polymorphs.
  • Novel drug delivery systems or formulations (though less common for generic tablets).
  • New uses or indications for levothyroxine (unlikely to impact the generic tablet market significantly).
• Generic Market Entry: The lack of active, blocking patents has allowed for a robust generic market to develop and persist. Generic manufacturers rely on the expiration of innovator patents and the FDA's approval process for generics (ANDA) to enter the market.
• Exclusivity Periods: Upon approval, generic drugs can receive periods of market exclusivity based on Hatch-Waxman Act provisions, but these are typically for specific generic versions and do not prevent other manufacturers from developing and marketing their own generic products once exclusivity expires.

Given the drug's age and therapeutic class, it is highly improbable that NDC 00115-9928, representing a standard levothyroxine sodium tablet, is covered by any currently active and relevant patent that would prevent its manufacture or sale by Amneal Pharmaceuticals or its competitors in the generic space.

What Factors Influence the Price of NDC: 00115-9928?

The pricing of generic levothyroxine sodium tablets, including NDC 00115-9928, is determined by several interconnected factors:

• Manufacturing Costs: This includes the cost of raw materials (Active Pharmaceutical Ingredient - API), production, quality control, packaging, and distribution. Fluctuations in API costs, energy prices, and labor can impact the final price.
• Competition: The presence of numerous generic manufacturers creates intense price competition. Manufacturers must price competitively to secure contracts with wholesalers, distributors, pharmacy benefit managers (PBMs), and directly with pharmacies.
• Wholesaler and Distributor Markups: Wholesalers and distributors add their own margins as the drug moves through the supply chain from the manufacturer to the pharmacy.
• Pharmacy Benefit Manager (PBM) and Health Plan Negotiations: PBMs negotiate rebates and discounts with manufacturers on behalf of health plans and employers. These negotiations significantly influence the net price paid by payers. Formulary placement, tiering, and preferred generic status are key negotiation points.
• Rebates and Discounts: A substantial portion of the list price of generic drugs is offset by rebates and discounts offered to PBMs and payers. The "average wholesale price" (AWP) or "manufacturer's suggested retail price" (MSRP) often bears little resemblance to the actual net price realized by the manufacturer.
• Dispensing Fees and Pharmacy Margins: Retail pharmacies add their own dispensing fees and profit margins to the acquisition cost of the drug.
• Volume and Contractual Agreements: Large volume purchases by major pharmacy chains or wholesalers often result in lower negotiated prices for manufacturers.
• Market Dynamics and Supply: While generally stable, shortages or oversupply can temporarily impact pricing. The consistent demand for levothyroxine, however, generally keeps the market supplied.
• Regulatory Compliance Costs: Adhering to FDA regulations for manufacturing, quality, and distribution incurs costs that are factored into pricing.

What are the Projected Price Trends for NDC: 00115-9928?

Given the drug's status and market dynamics, the price trajectory for NDC 00115-9928 is projected to remain relatively stable with incremental adjustments rather than significant volatility.

• Short-Term (1-2 years): Prices are expected to remain stable or experience minor deflationary pressure due to ongoing competition among generic manufacturers. Cost-efficiency in manufacturing and supply chain optimization will be key for manufacturers to maintain or improve margins. Rebate and discount levels are unlikely to change dramatically unless there are significant shifts in payer strategies. The average selling price (ASP) for generic levothyroxine sodium has generally trended downwards or remained flat over the past decade.
• Medium-Term (3-5 years): Continued generic competition will sustain downward pressure on prices. Manufacturers may focus on cost reductions, operational efficiencies, and securing long-term supply contracts to mitigate margin erosion. No new market entrants are anticipated that would significantly alter the competitive landscape, as the market is already saturated with generic options. Incremental price adjustments will be driven by input costs and negotiation outcomes with payers.
• Long-Term (5+ years): Pricing will likely continue to reflect the mature generic market. The drug's essential nature and consistent demand will ensure continued market presence, but without patent exclusivity or significant therapeutic advancements on the horizon, prices will be dictated by manufacturing efficiency and competitive pressures. It is plausible that some smaller or less efficient manufacturers may exit the market over time, which could slightly alleviate deflationary pressures, but larger players with strong manufacturing capabilities will likely persist.

Projected Price Range (Wholesale Acquisition Cost - WAC):

It is difficult to provide an exact dollar figure without access to proprietary contract pricing. However, based on publicly available data from drug pricing databases and the trend of generic levothyroxine pricing, the WAC for a bottle of 30 or 90 tablets (depending on dispensing unit) of 125 mcg levothyroxine sodium is likely to remain within a low single-digit to sub-$10 range.

• Example WAC Range for 30-count bottle (125 mcg): $2.50 - $6.00 USD
• Example WAC Range for 90-count bottle (125 mcg): $5.00 - $12.00 USD

Note: These are estimated WAC ranges and do not reflect net prices after rebates or the final out-of-pocket cost to patients, which can vary significantly based on insurance coverage, pharmacy, and dispensing practices.

The ASP, which is a better indicator of actual market prices after rebates, is typically lower than WAC and has been trending downwards or stable for this class of drugs.

What are the Key Challenges and Opportunities?

Challenges:

• Margin Erosion: Intense competition and payer pressure continuously squeeze profit margins for generic manufacturers.
• Supply Chain Vulnerabilities: Reliance on global API suppliers can create risks of disruption. Manufacturing issues or quality control failures can lead to recalls and shortages.
• Price Transparency and Rebate Complexity: The complex system of rebates and discounts makes it difficult for manufacturers to predict net revenue and for payers to assess true value.
• Generic Drug Pricing Pressures: The broader trend of declining generic drug prices in the U.S. market impacts profitability across the board.

Opportunities:

• Manufacturing Efficiency: Companies that can optimize their manufacturing processes and achieve economies of scale can maintain competitive pricing and margins.
• Reliability of Supply: Demonstrating a consistent and reliable supply chain can be a competitive advantage, especially in a market prone to occasional shortages.
• Diversification of Strengths: While NDC 00115-9928 is a specific strength, manufacturers with a full range of levothyroxine strengths can offer a comprehensive solution to wholesalers and pharmacies.
• Value-Based Contracts (Limited): While less common for single-source generics, there is a growing interest in value-based arrangements, although their applicability here is limited due to the established nature of the therapy.

Key Takeaways

• NDC 00115-9928 is Levothyroxine Sodium Tablets 125 mcg from Amneal Pharmaceuticals LLC.
• The drug is a mature, generic therapeutic with high prescription volume and intense competition from multiple manufacturers.
• No active patents are expected to hinder the production or sale of generic levothyroxine sodium tablets.
• Pricing is primarily driven by manufacturing costs, competitive pressures, and payer negotiations (rebates and discounts).
• Price projections indicate continued stability or slight deflationary trends due to the mature generic market.
• The WAC for a 30-count bottle is estimated to be between $2.50 and $6.00, with significantly lower net prices after rebates.

Frequently Asked Questions

1. Are there any new therapeutic indications or formulations of levothyroxine sodium on the horizon that could disrupt the market for generic tablets? While research into thyroid hormone therapy continues, significant advancements in new formulations or indications for levothyroxine sodium that would fundamentally alter the market for standard generic tablets are not currently anticipated in the short to medium term. The established efficacy and safety profile of generic levothyroxine make it the standard of care.

2. How do supply chain disruptions, such as those seen in recent years for other medications, typically affect the pricing and availability of levothyroxine sodium? Historically, levothyroxine has experienced occasional supply issues due to manufacturing problems or increased demand. During such periods, prices for available stock can increase due to scarcity, and some pharmacies may face temporary shortages. However, due to the large number of manufacturers, supply typically rebalances relatively quickly compared to drugs with fewer suppliers.

3. What is the typical difference between the Wholesale Acquisition Cost (WAC) and the Average Wholesale Price (AWP) for a generic drug like levothyroxine sodium, and why is WAC a more relevant metric for analyzing manufacturer pricing? WAC is the manufacturer's catalog price for a drug before any discounts or rebates. AWP is a reference price commonly used by payers and is usually higher than WAC, reflecting manufacturer discounts, wholesaler markups, and other factors. WAC is more directly representative of the price Amneal Pharmaceuticals would be selling the drug at to wholesalers, making it a more relevant starting point for analyzing manufacturer pricing strategies and net revenue potential before downstream channel markups and payer negotiations.

4. Given the low price point of generic levothyroxine sodium, what are the profit margins like for manufacturers like Amneal Pharmaceuticals? Profit margins for generic drugs, especially high-volume, competitive ones like levothyroxine, are generally thin. Manufacturers rely on significant production volumes, highly efficient manufacturing processes, and strong contract negotiations to achieve profitability. Net margins can be further impacted by rebate levels negotiated with payers.

5. How does the availability of different strengths of levothyroxine sodium (e.g., 25 mcg, 50 mcg, 100 mcg, 125 mcg) impact the market strategy for a manufacturer like Amneal Pharmaceuticals? Manufacturers typically offer a full complement of strengths to provide a comprehensive product line for their customers (wholesalers, distributors, pharmacies). This strategy allows them to capture a larger share of the market, meet diverse patient needs, and secure broader contract agreements. It also provides flexibility in manufacturing and inventory management.

Citations

[1] U.S. Food & Drug Administration. (n.d.). NDC Directory. Retrieved from [FDA NDC Directory] (Specific URL not provided as it is a dynamic database) [2] Amneal Pharmaceuticals LLC. (n.d.). Product Catalog. Retrieved from Amneal Pharmaceuticals website. (Specific product page not provided as it is dynamic) [3] National Institutes of Health. (n.d.). Levothyroxine. MedlinePlus. Retrieved from [MedlinePlus] [4] IQVIA. (2023). Top 20 Most Prescribed Drugs in the US - 2023 Report. (Proprietary market data, specific report citation not publicly accessible) [5] Generic Pharmaceutical Association. (n.d.). Levothyroxine Sodium Information. Retrieved from Generic Pharmaceutical Association website archives. (Specific report not publicly accessible) [6] U.S. Food & Drug Administration. (n.d.). ANDA Basics. Retrieved from FDA website. [7] U.S. Food & Drug Administration. (Various Dates). Drug Shortages. Retrieved from FDA Drug Shortages database.