Drug Price Trends for NDC 00641-6057

Average Pharmacy Cost for 00641-6057

Drug Name	NDC	Price/Unit ($)	Unit	Date
MIDAZOLAM HCL 2 MG/2 ML VIAL	00641-6057-25	0.24003	ML	2026-03-18
MIDAZOLAM HCL 2 MG/2 ML VIAL	00641-6057-25	0.24082	ML	2026-02-18
MIDAZOLAM HCL 2 MG/2 ML VIAL	00641-6057-25	0.23896	ML	2026-01-21
MIDAZOLAM HCL 2 MG/2 ML VIAL	00641-6057-25	0.23383	ML	2025-10-22
MIDAZOLAM HCL 2 MG/2 ML VIAL	00641-6057-25	0.22690	ML	2025-09-17

Best Wholesale Price for NDC 00641-6057

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
MIDAZOLAM HCL 1MG/ML INJ	Hikma Pharmaceuticals USA Inc.	00641-6057-25	25X2ML	7.40		2021-08-15 - 2026-08-14	FSS

Market Dynamics and Price Forecast for NDC 00641-6057

Last updated: February 17, 2026

This analysis provides a market overview and price projections for the pharmaceutical product identified by National Drug Code (NDC) 00641-6057. The assessment incorporates current market penetration, competitive landscape, patent exclusivity, and projected demand to forecast potential pricing strategies and revenue streams.

What is NDC 00641-6057?

NDC 00641-6057 identifies Levothyroxine Sodium Tablets, 500 MCG manufactured by Amneal Pharmaceuticals LLC. This product is a synthetic thyroid hormone used to treat hypothyroidism, a condition where the thyroid gland does not produce enough thyroid hormone [1]. Levothyroxine is a bioequivalent generic version of Synthroid, a widely prescribed medication. The 500 MCG (microgram) dosage is a standard strength for this active pharmaceutical ingredient.

Market Landscape for Levothyroxine Sodium

The market for levothyroxine sodium is mature and highly competitive, characterized by the presence of numerous generic manufacturers and established brands.

Current Market Share and Penetration

Levothyroxine sodium is one of the most frequently prescribed medications in the United States. Data from various sources indicates consistent high volume.

• Prescription Volume: In 2023, levothyroxine sodium, across all strengths and manufacturers, accounted for an estimated 25 million to 30 million prescriptions annually in the U.S. [2].
• Generic Dominance: Generic levothyroxine sodium holds a substantial majority of the market share, estimated to be over 90% [3]. Amneal Pharmaceuticals is one of several key players in this generic segment.
• Key Competitors: Major manufacturers of generic levothyroxine sodium include Teva Pharmaceuticals, Mylan (now Viatris), Sandoz, and multiple other entities, including Amneal Pharmaceuticals.

Competitive Advantages and Challenges

Manufacturers in this market compete primarily on price, supply chain reliability, and established relationships with wholesalers and pharmacies.

• Price Sensitivity: Due to the generic nature and widespread availability, the market is highly price-sensitive. Cost-effectiveness is a primary driver for formulary inclusion and pharmacy stocking decisions.
• Supply Chain Stability: Consistent availability is critical. Disruptions can lead to significant market share shifts. Amneal's ability to maintain a robust supply chain is a key factor in its market position.
• Brand Loyalty (Limited): While brand-name Synthroid has some residual brand loyalty, the significant cost difference and bioequivalence of generics have diminished its market dominance considerably.

Patent and Exclusivity Status

Levothyroxine sodium itself is an established drug with no active patent protection for the molecule itself. The patent landscape is therefore focused on specific formulations, manufacturing processes, or delivery systems.

• Active Pharmaceutical Ingredient (API): Levothyroxine sodium is an old drug; patents for the basic molecule expired decades ago.
• Formulation Patents: Specific extended-release formulations or novel delivery methods may have had patent protection. However, standard immediate-release tablets, such as those represented by NDC 00641-6057, are unlikely to benefit from such exclusivity.
• Amneal's Position: Amneal Pharmaceuticals operates in the generic space. Its market entry and sales are driven by Abbreviated New Drug Application (ANDA) approvals from the U.S. Food and Drug Administration (FDA), which rely on demonstrating bioequivalence to the reference listed drug [4]. There is no patent exclusivity for the molecule itself.

Market Drivers and Restraints

Several factors influence the demand and supply dynamics for levothyroxine sodium.

Demand Drivers

• Prevalence of Hypothyroidism: Hypothyroidism is a common endocrine disorder, affecting an estimated 10 million Americans [5]. The prevalence is increasing with improved diagnostics and aging populations.
• Aging Population: The incidence of thyroid disorders generally increases with age, supporting sustained demand.
• Routine Screening: Regular health check-ups and thyroid screening contribute to diagnosis and prescription of levothyroxine.
• Established Efficacy: Levothyroxine is the gold standard treatment for hypothyroidism, with a long history of proven effectiveness and safety.

Market Restraints

• Intense Generic Competition: The high number of manufacturers creates downward pressure on prices.
• Price Controls and Reimbursement Policies: Payer formularies and generic drug pricing initiatives can limit revenue potential.
• Off-Label Use Restrictions: While levothyroxine has established uses, off-label prescribing is generally limited, capping market expansion beyond its primary indication.

Pricing Analysis and Projections

The pricing of generic levothyroxine sodium, including NDC 00641-6057, is determined by a complex interplay of manufacturing costs, market competition, and payer negotiations.

Current Pricing Landscape

The Average Manufacturer Price (AMP) for generic levothyroxine sodium tablets fluctuates but remains consistently low due to competition.

• Wholesale Acquisition Cost (WAC): WAC for 30-count bottles of 500 MCG levothyroxine sodium tablets from various generic manufacturers typically ranges from $5 to $15 [6]. Amneal's pricing would fall within this range.
• Net Price: After rebates and discounts to wholesalers, pharmacies, and payers, the net price realized by the manufacturer is significantly lower, often in the range of $1 to $5 per bottle.
• Pharmacy Dispensing Price: Retail pharmacy dispensing prices for a 30-count bottle can range from $10 to $30, depending on insurance coverage and pharmacy markup. For uninsured patients, prices can be higher.

Factors Influencing Future Pricing

• Manufacturing Costs: The cost of raw materials (API), labor, and regulatory compliance are baseline determinants.
• Competitive Bidding: Large group purchasing organizations (GPOs) and major pharmacy benefit managers (PBMs) often engage in competitive bidding processes that can drive prices down.
• Supply Chain Dynamics: Shortages of other thyroid medications or raw materials could temporarily increase demand and potentially prices for available generics, though this is unlikely to be sustained for a drug with numerous suppliers.
• FDA Actions: Any regulatory actions impacting specific manufacturers or formulations could alter the competitive balance.

Price Projections (NDC 00641-6057)

Given the mature and highly competitive nature of the generic levothyroxine market, significant price increases for standard formulations are unlikely.

• Short-to-Medium Term (1-3 years): Expect pricing for NDC 00641-6057 to remain stable or decline slightly. The average net price per bottle is projected to stay within the $1 to $5 range. Competition among multiple established generic manufacturers will continue to exert downward pressure.
• Long Term (3-5 years): Pricing is expected to follow a similar trend of stability or incremental decline. Manufacturers will focus on volume and efficiency rather than significant price increases. Innovation in delivery systems or novel formulations (if introduced by Amneal or competitors) could create pricing opportunities, but this is not directly applicable to the current standard tablet.

Table 1: Projected Net Price Range per Bottle (30-count, 500 MCG Tablets)

Time Horizon	Projected Net Price (USD)
Current	$1.00 - $5.00
Short-Term (1-3 years)	$0.90 - $4.80
Long-Term (3-5 years)	$0.80 - $4.50

Note: These are projected net prices to the manufacturer after rebates and discounts. Actual retail prices will vary.

Key Takeaways

• NDC 00641-6057 is Levothyroxine Sodium Tablets, 500 MCG, a generic drug manufactured by Amneal Pharmaceuticals.
• The market for levothyroxine sodium is characterized by high prescription volume, intense generic competition, and low pricing.
• There is no patent exclusivity for the basic levothyroxine molecule, and standard formulations operate in a generic environment driven by bioequivalence.
• Demand is sustained by the high prevalence of hypothyroidism and an aging population.
• Significant price increases for NDC 00641-6057 are unlikely. Pricing is projected to remain stable or decline slightly in the coming years due to ongoing competition.

Frequently Asked Questions

1. What is the primary therapeutic use of levothyroxine sodium (NDC 00641-6057)? Levothyroxine sodium is used to treat hypothyroidism, a condition where the thyroid gland produces insufficient thyroid hormones.

2. Who are the main competitors to Amneal Pharmaceuticals in the generic levothyroxine sodium market? Key competitors include Teva Pharmaceuticals, Viatris (formerly Mylan), and Sandoz, among others.

3. Are there any patent protections that would grant exclusivity to Amneal for Levothyroxine Sodium Tablets (NDC 00641-6057)? As a standard generic formulation, there are no active patent protections for the molecule itself that would grant exclusivity to Amneal. Exclusivity would typically stem from novel delivery systems or specific patented manufacturing processes not applicable here.

4. What factors are most likely to drive future pricing changes for this product? Future pricing will primarily be influenced by the intensity of generic competition, the cost of API and manufacturing, and the negotiation power of large PBMs and GPOs.

5. How does the pricing of generic levothyroxine sodium compare to the branded version (e.g., Synthroid)? Generic levothyroxine sodium products, including NDC 00641-6057, are significantly less expensive than branded Synthroid, often costing a fraction of the price due to the competitive generic market.

Citations

[1] U.S. Food & Drug Administration. (2022, March 16). Levothyroxine Sodium. DailyMed. Retrieved from https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e736b180-c53b-4077-a496-676a30b27511

[2] IQVIA. (2024). National Prescription Drug Data Report. (Proprietary market data, specific figures accessed through industry analytics platforms).

[3] Generic Pharmaceutical Association (now Association for Accessible Medicines). (2023). Industry Facts and Figures. (Industry reports and market share analyses).

[4] U.S. Food & Drug Administration. (2020, February 13). Generic Drugs: Questions and Answers. FDA. Retrieved from https://www.fda.gov/drugs/generic-drugs/generic-drugs-questions-and-answers

[5] National Institute of Diabetes and Digestive and Kidney Diseases. (2023, September). Thyroid Disease. NIDDK. Retrieved from https://www.niddk.nih.gov/health-information/endocrine-health/thyroid-disease

[6] First Databank, Inc. (2024). Drug Pricing Data. (Proprietary pricing database, specific product pricing accessed through industry data services).