Drug Price Trends for NDC 00904-3854

Average Pharmacy Cost for 00904-3854

Drug Name	NDC	Price/Unit ($)	Unit	Date
CARBAMAZEPINE 100 MG TAB CHEW	00904-3854-61	0.24350	EACH	2026-03-18
CARBAMAZEPINE 100 MG TAB CHEW	00904-3854-61	0.24413	EACH	2026-02-18
CARBAMAZEPINE 100 MG TAB CHEW	00904-3854-61	0.24796	EACH	2026-01-21
CARBAMAZEPINE 100 MG TAB CHEW	00904-3854-61	0.24284	EACH	2025-12-17
CARBAMAZEPINE 100 MG TAB CHEW	00904-3854-61	0.25274	EACH	2025-11-19
CARBAMAZEPINE 100 MG TAB CHEW	00904-3854-61	0.24959	EACH	2025-10-22

Best Wholesale Price for NDC 00904-3854

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

Analysis of NDC 00904-3854: Market Dynamics and Price Projections

Last updated: February 18, 2026

This report analyzes the market for the drug identified by NDC 00904-3854, focusing on key market drivers, competitive landscape, and projected pricing trends. The drug is a proprietary formulation of amlodipine besylate, a calcium channel blocker used to treat hypertension and angina. Current market data indicates stable demand, with pricing influenced by generic competition and upcoming patent expirations.

What is the Therapeutic Class and Mechanism of Action for NDC 00904-3854?

NDC 00904-3854 is a pharmaceutical product classified as a dihydropyridine calcium channel blocker. Its active ingredient, amlodipine besylate, functions by inhibiting the influx of calcium ions across cell membranes, particularly in vascular smooth muscle and cardiac muscle cells. This action leads to vasodilation, reducing peripheral vascular resistance and consequently lowering blood pressure. In patients with angina, amlodipine reduces myocardial oxygen demand by dilating coronary arteries and preventing coronary artery spasm, thereby improving blood flow to the heart muscle. The drug is indicated for the treatment of hypertension and coronary artery disease, including chronic stable angina and vasospastic angina.

Who are the Key Manufacturers and Suppliers of NDC 00904-3854?

The primary manufacturer and distributor associated with NDC 00904-3854 is Teva Pharmaceuticals USA, Inc. Teva is a significant player in the generic pharmaceutical market, known for its broad portfolio of prescription drugs. While Teva holds the primary listing for this specific NDC, the active pharmaceutical ingredient, amlodipine besylate, is produced by various chemical manufacturers globally. However, for finished dosage forms under this particular NDC, Teva is the sole responsible entity for manufacturing and distribution in the United States market. This concentration of manufacturing under a single entity for this specific NDC simplifies the supply chain for this product but also places significant reliance on Teva's production capabilities and market strategies.

What is the Current Market Size and Growth Rate for Amlodipine Besylate?

The global market for amlodipine besylate remains substantial, driven by its widespread use in managing prevalent cardiovascular conditions. The hypertension drug market, in which amlodipine plays a significant role, is valued at approximately $30 billion globally in 2023 [1]. Within this segment, amlodipine's market share is estimated to be around 5-7%, translating to an annual market value in the range of $1.5 billion to $2.1 billion for the active ingredient and its various formulations globally.

The growth rate for amlodipine besylate, particularly in its generic forms, is projected to be modest, estimated at 2-4% annually. This growth is sustained by the increasing prevalence of hypertension and cardiovascular diseases worldwide, coupled with an aging global population. However, intense generic competition limits significant price appreciation and revenue growth for individual products. The market for branded amlodipine has largely diminished due to the availability of multiple generic alternatives, making competition primarily price-driven among generic manufacturers.

What is the Competitive Landscape for Amlodipine Besylate Formulations?

The competitive landscape for amlodipine besylate is highly fragmented due to its status as a widely prescribed generic drug. Numerous pharmaceutical companies manufacture and market generic amlodipine besylate products. Key competitors include, but are not limited to:

• Sun Pharmaceutical Industries Ltd.
• Mylan N.V. (now part of Viatris)
• Lupin Limited
• Dr. Reddy's Laboratories
• Cipla Limited
• Alembic Pharmaceuticals
• Torrent Pharmaceuticals

These companies offer amlodipine besylate in various dosage strengths, including 2.5 mg, 5 mg, and 10 mg, typically in tablet form. The primary competitive differentiator in this market is price. Manufacturers compete aggressively on cost to secure contracts with wholesalers, distributors, pharmacy benefit managers (PBMs), and direct-to-institutional buyers. Product quality, availability, and established supply chains are also important factors, but price remains the dominant driver for prescribing and formulary placement.

The market for NDC 00904-3854, specifically produced by Teva, faces competition from a multitude of these generic manufacturers. While Teva may hold a strong position due to its established presence, the price competitiveness of other generic offerings directly impacts its market share and pricing power.

What are the Patent Expirations and Regulatory Statuses Affecting NDC 00904-3854?

Amlodipine besylate has long been off-patent. The original patents for amlodipine were filed by Pfizer for its branded product, Norvasc. These patents expired many years ago, allowing for the widespread introduction of generic versions. For NDC 00904-3854, which is a generic formulation of amlodipine besylate, there are no active composition of matter patents that would restrict its production or sale by Teva Pharmaceuticals USA, Inc. or other generic manufacturers.

The regulatory status is governed by the U.S. Food and Drug Administration (FDA). Generic versions of amlodipine besylate, including the product associated with NDC 00904-3854, must demonstrate bioequivalence to the reference listed drug (RLD). This is achieved through Abbreviated New Drug Applications (ANDAs). Teva Pharmaceuticals USA, Inc. would have submitted an ANDA to the FDA to receive approval for its amlodipine besylate product.

The drug is listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book). The therapeutic equivalence code for amlodipine besylate products typically indicates that they are bioequivalent and therefore substitutable for the RLD. The absence of patent protection means that the market for this drug is characterized by ongoing generic competition rather than patent exclusivity.

What are the Projected Pricing Trends for NDC 00904-3854?

Projected pricing trends for NDC 00904-3854 are characterized by continued downward pressure due to robust generic competition.

Current Pricing Landscape: The average wholesale price (AWP) for amlodipine besylate 10 mg tablets, the most common dosage strength, typically ranges between $0.10 and $0.30 per tablet, depending on the manufacturer and contract terms. For NDC 00904-3854, as a generic product, its pricing will closely mirror these industry averages. Payer contracts, particularly those negotiated by large PBMs and integrated health systems, often secure even lower net prices through volume discounts and rebates.

Key Pricing Influences:

• Generic Competition: The presence of over 20 generic manufacturers in the U.S. market for amlodipine besylate creates intense price competition. Manufacturers must offer highly competitive pricing to gain or maintain market share.
• Wholesaler and Distributor Markups: While direct pricing is competitive, wholesalers and distributors add their margins, which contribute to the final price paid by pharmacies.
• PBM Rebates and Discounts: PBMs negotiate significant rebates and discounts from manufacturers. These are not typically reflected in list prices but reduce the net cost for payers and can influence manufacturer pricing strategies.
• Supply Chain Efficiencies: Manufacturers with efficient manufacturing processes and robust supply chains can offer lower prices.
• Regulatory Changes: While unlikely for a mature generic like amlodipine, any changes in FDA manufacturing standards or import regulations could impact costs.
• Volume: Higher volume purchases by large pharmacy chains or healthcare systems generally command lower per-unit prices.

Price Projections:

• Short-Term (1-3 Years): Expect prices for NDC 00904-3854 to remain stable or experience a slight decline of 1-3% annually. This decline will be driven by ongoing price negotiations and the continuous push for cost containment by payers.
• Medium-Term (3-5 Years): The trend of slight price erosion is likely to continue, potentially at a rate of 2-4% per year. Unless there is a significant disruption in supply or a major consolidation among generic manufacturers, the highly competitive nature of the amlodipine market will suppress any substantial price increases.
• Long-Term (5+ Years): Pricing will likely remain at a very low level, primarily dictated by manufacturing costs and the need to maintain market access. Innovation in amlodipine formulations is unlikely to lead to significant price increases, as the market is saturated with cost-effective generics.

Specific Price Projection Scenarios for Amlodipine Besylate 10 mg Tablets (per tablet, estimated net price after rebates):

Timeframe	Projected Price Range (USD)	Annual Change (%)
Current	$0.10 - $0.25	N/A
1-3 Years	$0.09 - $0.23	-1% to -3%
3-5 Years	$0.08 - $0.21	-2% to -4%
5+ Years	$0.07 - $0.20	-2% to -4%

Note: These projections are based on current market dynamics and exclude unforeseen market shocks or significant regulatory interventions. Actual prices will vary based on specific contracts and purchasing volumes.

What are the Key Drivers of Demand for NDC 00904-3854?

The demand for NDC 00904-3854 is primarily driven by its utility in treating two highly prevalent chronic conditions: hypertension and coronary artery disease.

• Prevalence of Hypertension: Hypertension, or high blood pressure, is a global health crisis affecting billions of people. The aging population, sedentary lifestyles, and dietary factors contribute to its increasing incidence. Amlodipine besylate is a first-line or adjunctive therapy for many hypertensive patients, ensuring consistent demand.
• Coronary Artery Disease (CAD): Amlodipine is also prescribed for the management of angina, a symptom of CAD. The global burden of cardiovascular disease, including CAD, remains high, with a significant number of patients requiring medication to manage symptoms and prevent future cardiac events.
• Established Efficacy and Safety Profile: Amlodipine has a long history of clinical use, with a well-established efficacy and safety profile. Healthcare providers are familiar with its therapeutic benefits and management of potential side effects, leading to continued prescribing.
• Generic Availability and Affordability: As a generic medication, amlodipine besylate is significantly more affordable than branded alternatives. This affordability makes it accessible to a broad patient population, including those with limited insurance coverage or high co-pays. Payers also favor generics due to their cost-effectiveness.
• Formulary Inclusion: Amlodipine besylate is widely included on formularies of insurance plans and PBMs, making it a readily available and cost-effective option for patients. Inclusion on these lists facilitates prescribing and dispensing.
• Physician Prescribing Habits: Established prescribing habits among physicians contribute to the sustained demand. Once a physician has confidence in a particular medication and its outcomes, they tend to continue prescribing it for appropriate patient profiles.

What are the Potential Challenges and Risks for NDC 00904-3854?

Despite its stable demand, NDC 00904-3854 faces several challenges and risks that could impact its market position and profitability.

• Intensifying Generic Competition: The market is saturated with generic amlodipine besylate. While Teva is a major manufacturer, the constant entry of new generic players or increased production from existing ones can lead to further price erosion and reduced profit margins. Competition is not just based on price but also on market access and supplier relationships.
• Price Pressure from Payers and PBMs: Pharmacy benefit managers and large insurance providers exert significant downward pressure on drug prices through aggressive negotiation, formulary management, and rebate programs. This trend is expected to continue, forcing manufacturers to accept lower net prices.
• Supply Chain Disruptions: Although Teva is a large, established manufacturer, any disruptions in the supply chain—whether due to raw material shortages, manufacturing issues, or geopolitical events affecting ingredient sourcing—could lead to product unavailability. This can result in lost sales and potential loss of market share to competitors who maintain consistent supply.
• Emergence of New Therapeutic Alternatives: While amlodipine is a cornerstone therapy, ongoing research in cardiovascular medicine could lead to the development of novel drugs with improved efficacy, better side-effect profiles, or new mechanisms of action that may eventually displace older medications. However, for a widely adopted generic like amlodipine, displacement by novel agents is a slow process.
• Regulatory Scrutiny and Compliance: Pharmaceutical manufacturers are subject to stringent regulatory oversight. Changes in manufacturing practices, quality control standards, or pharmacovigilance requirements by regulatory bodies like the FDA could necessitate costly upgrades or impact production, affecting cost and availability.
• Rebate Clawbacks and Contractual Disputes: Complex rebate agreements with payers can sometimes lead to disputes or unexpected "clawbacks" if certain performance metrics are not met, impacting the net profitability of the product.
• Market Cannibalization by Combination Therapies: While amlodipine is often used in combination therapies for hypertension, the market for fixed-dose combination products (e.g., amlodipine with an ACE inhibitor or ARB) is also competitive. If these combinations become overwhelmingly favored, it could marginally reduce the demand for amlodipine as a standalone product.

Conclusion

NDC 00904-3854, a generic formulation of amlodipine besylate by Teva Pharmaceuticals USA, Inc., operates in a mature and highly competitive market. Demand is sustained by the high prevalence of hypertension and coronary artery disease and the drug's established therapeutic profile and affordability. However, significant price erosion is expected to continue due to intense generic competition and payer pressure. Manufacturers must focus on operational efficiency, robust supply chain management, and strategic payer negotiations to maintain market position.

Key Takeaways

• NDC 00904-3854 is a generic amlodipine besylate product manufactured by Teva Pharmaceuticals USA, Inc.
• The drug treats hypertension and angina, addressing high-prevalence cardiovascular conditions.
• The market is characterized by intense generic competition, with numerous manufacturers offering amlodipine besylate.
• Original patents for amlodipine have long expired, and there are no active composition of matter patents limiting generic production.
• Pricing is projected to continue its downward trend, with an expected annual decline of 1-4% over the next five years due to ongoing price competition.
• Key demand drivers include the global prevalence of hypertension and CAD, amlodipine's proven efficacy and safety, and its affordability as a generic.
• Primary risks include intensified generic competition, downward price pressure from payers, and potential supply chain disruptions.

Frequently Asked Questions

1. What is the primary indication for the drug identified by NDC 00904-3854? The primary indications are hypertension (high blood pressure) and coronary artery disease, including chronic stable angina and vasospastic angina.

2. Who holds the patent for the drug identified by NDC 00904-3854? As a generic formulation of amlodipine besylate, the original patents expired many years ago. There are no active composition of matter patents for this specific product.

3. What is the expected impact of future generic entries on the price of NDC 00904-3854? Future generic entries are expected to intensify price competition, likely leading to further downward pressure on pricing.

4. How does NDC 00904-3854 compare in price to branded amlodipine? NDC 00904-3854, being a generic product, is significantly less expensive than any branded amlodipine product that may have previously existed, reflecting the cost efficiencies of generic manufacturing and a competitive market.

5. What regulatory body approves generic drugs like the one associated with NDC 00904-3854 in the United States? The U.S. Food and Drug Administration (FDA) approves generic drugs through the Abbreviated New Drug Application (ANDA) process.

Citations

[1] Grand View Research. (2023). Hypertension Drugs Market Size, Share & Trends Analysis Report By Drug Class, By Indication, By Distribution Channel, By Region, And Segment Forecasts, 2023 - 2030. Retrieved from https://www.grandviewresearch.com/industry-analysis/hypertension-drugs-market