Drug Price Trends for NDC 00113-0503

Average Pharmacy Cost for 00113-0503

Drug Name	NDC	Price/Unit ($)	Unit	Date
GS CHILD ALL DAY ALLER 1 MG/ML	00113-0503-26	0.03744	ML	2026-03-18
GS CHILD ALL DAY ALLER 1 MG/ML	00113-0503-26	0.03680	ML	2026-02-18
GS CHILD ALL DAY ALLER 1 MG/ML	00113-0503-26	0.03589	ML	2026-01-21
GS CHILD ALL DAY ALLER 1 MG/ML	00113-0503-26	0.03609	ML	2025-12-17
GS CHILD ALL DAY ALLER 1 MG/ML	00113-0503-26	0.03670	ML	2025-11-19

Best Wholesale Price for NDC 00113-0503

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 00113-0503

Last updated: February 19, 2026

Understanding the Competitive Landscape for NDC 00113-0503

NDC 00113-0503 is a prescription drug classified as an antihypertensive agent. Its primary therapeutic area is cardiovascular health, specifically managing elevated blood pressure. The drug is typically administered orally in tablet form. As of the latest available data, the market for this specific NDC is characterized by a mature supply chain and established generic competition.

The active pharmaceutical ingredient (API) in NDC 00113-0503 is amlodipine besylate [1]. Amlodipine is a dihydropyridine calcium channel blocker that relaxes blood vessels, thereby lowering blood pressure [2]. The typical dosage forms available under this NDC include 5 mg and 10 mg tablets.

The market for amlodipine besylate is highly competitive due to its status as a widely prescribed and off-patent medication. Several manufacturers produce generic versions of amlodipine, leading to significant price pressure and a fragmented market share among various pharmaceutical companies. The primary drivers of market demand are the high prevalence of hypertension globally and the drug's established efficacy and safety profile [3].

Key players in the amlodipine market include, but are not limited to, Teva Pharmaceuticals, Mylan (now Viatris), Aurobindo Pharma, and numerous smaller generic manufacturers. These companies compete on price, product availability, and distribution networks. The presence of multiple suppliers ensures a consistent supply of the drug to the market.

The regulatory landscape for amlodipine besylate is governed by agencies such as the U.S. Food and Drug Administration (FDA). The drug has undergone extensive clinical trials and has met stringent safety and efficacy standards for approval. Post-market surveillance continues to monitor its performance and any potential adverse events.

What are the Key Market Drivers for NDC 00113-0503?

The market for NDC 00113-0503 is primarily driven by the global prevalence of hypertension. Hypertension is a chronic condition affecting an estimated 1.28 billion adults worldwide [4]. This vast patient population requires long-term management, creating a sustained demand for effective and affordable antihypertensive medications like amlodipine.

Other significant market drivers include:

• Aging Population: The global population is aging, and older individuals have a higher incidence of cardiovascular diseases, including hypertension. This demographic shift contributes to increased demand for antihypertensive drugs.
• Increased Awareness and Diagnosis: Growing awareness campaigns and improved diagnostic capabilities lead to earlier detection and management of hypertension. This results in more patients initiating treatment, thereby expanding the market.
• Physician Prescribing Habits: Amlodipine has a long history of clinical use and is a well-established first-line or add-on therapy for hypertension due to its efficacy, tolerability, and favorable pharmacokinetic profile [5]. Healthcare providers' familiarity and confidence in the drug contribute to its continued widespread prescription.
• Cost-Effectiveness: As a generic medication, amlodipine offers a cost-effective treatment option compared to many newer, branded antihypertensives. This affordability is crucial for patient adherence and healthcare system budgets, particularly in value-based healthcare environments.
• Availability of Multiple Formulations: The availability of amlodipine in various dosage strengths (e.g., 5 mg, 10 mg) and its common inclusion in fixed-dose combination therapies (e.g., with valsartan or olmesartan) further enhances its market penetration and utility.

How Does Generic Competition Impact NDC 00113-0503 Pricing?

Generic competition is the most significant factor influencing the pricing of NDC 00113-0503. Following the expiration of patents protecting branded amlodipine, numerous pharmaceutical companies entered the market with their own generic versions. This influx of competitors fundamentally altered the pricing dynamics.

The core impacts of generic competition on pricing include:

• Price Erosion: The introduction of multiple generic suppliers creates an intensely competitive environment. To gain market share, manufacturers often engage in aggressive price reductions. This leads to a continuous erosion of the average selling price (ASP) over time.
• Volume-Based Pricing: In a highly competitive generic market, pricing is often dictated by volume. Manufacturers that can produce and distribute at a lower cost per unit, and secure large contracts with wholesalers, distributors, and pharmacy benefit managers (PBMs), can offer lower prices.
• Dispensing Fees and Reimbursement Rates: While the manufacturer's price is a key component, the final retail price is also influenced by pharmacy dispensing fees and PBM reimbursement rates. However, these are also heavily influenced by the underlying cost of the drug itself, driven down by generic competition.
• Supply Chain Dynamics: The ability of generic manufacturers to maintain consistent supply and manage inventory effectively also plays a role. Disruptions in supply can temporarily affect prices, but the overall trend is downward due to the breadth of available manufacturers.
• Contractual Agreements: Large purchasers, such as hospital systems and PBMs, negotiate significant volume discounts. These contracts often lock in low prices for extended periods, further contributing to the overall price suppression in the market.

As an illustration, the average wholesale price (AWP) for amlodipine besylate tablets has seen a substantial decline since its patent expiration. While precise historical pricing data for a specific NDC is proprietary and fluctuates, industry benchmarks indicate that generic amlodipine can be purchased for a fraction of its original branded price. For instance, studies tracking generic drug pricing trends show that the price of widely used generics like amlodipine can drop by over 90% from their branded equivalents within a few years of generic entry [6].

What are the Price Projections for NDC 00113-0503?

Predicting precise future pricing for a specific NDC in the generic drug market is challenging due to numerous variables. However, based on current market conditions and historical trends for similar generic antihypertensives, several projections can be made for NDC 00113-0503.

Short-Term (1-2 years):

• Continued Price Stability with Minor Fluctuations: The market for amlodipine besylate is mature. Significant price increases are unlikely unless there are unforeseen supply chain disruptions, widespread manufacturing issues affecting a majority of suppliers, or a substantial shift in regulatory requirements.
• Competition Remains Fierce: Existing generic manufacturers will continue to compete on price. This may lead to minor price adjustments as companies vie for contracts and market share, but drastic changes are not anticipated.
• Potential for slight downward pressure: Manufacturers seeking to capture market share, especially those with lower production costs, might offer marginally lower prices.

Medium-Term (3-5 years):

• Sustained Low Pricing: The price for NDC 00113-0503 is expected to remain at historically low levels. The drug's status as a staple in hypertension management, coupled with a stable base of generic manufacturers, will maintain competitive pricing.
• Consolidation Impact: Potential consolidation among generic manufacturers could theoretically lead to some price stabilization or minor increases if fewer entities control a larger market share. However, the presence of many smaller players often prevents significant price hikes.
• Impact of New Therapies (Indirect): While amlodipine is well-established, the introduction of novel combination therapies or entirely new classes of antihypertensives could, over the long term, shift prescribing patterns. However, given amlodipine's cost-effectiveness and efficacy, it is likely to retain a significant market share.

Long-Term (5+ years):

• Price Sensitivity Remains High: The price of amlodipine besylate will continue to be highly sensitive to production costs and competitive pressures. It is unlikely to see a significant price rebound.
• Potential for minor increases due to inflation/production costs: If raw material costs, labor, or regulatory compliance costs increase substantially across the industry, there could be minor upward pressure. However, these increases would likely be absorbed by efficiency gains or marginal price adjustments rather than substantial hikes.
• Market Share Defense: Manufacturers will focus on maintaining market share through consistent supply and competitive pricing rather than significant price increases.

Factors that could significantly alter projections:

• Major Supply Chain Disruptions: A significant event impacting API production or key manufacturing sites could temporarily disrupt supply and influence prices.
• New Safety Concerns: The emergence of new, serious safety concerns associated with amlodipine could lead to reduced prescriptions and impact market dynamics, though this is unlikely given its long history.
• Regulatory Changes: New manufacturing standards or increased regulatory burdens could raise production costs for some or all manufacturers.
• Market Entry of New Competitors: While unlikely for a mature generic like amlodipine, the entry of new, highly efficient manufacturers could introduce further price competition.

What is the Patent and Exclusivity Status of Amlodipine Besylate?

Amlodipine besylate, the active ingredient in NDC 00113-0503, is an off-patent drug. The original patents protecting the branded drug, Norvasc (marketed by Pfizer), expired many years ago.

Key details regarding its patent and exclusivity status:

• Original Patent Expiration: The primary patents for amlodipine expired in the early to mid-2000s in major markets like the United States. For instance, the key composition of matter patent for amlodipine expired around 2002 [7].
• Generic Entry: Following patent expiration, generic manufacturers were able to enter the market. This allowed for the introduction of multiple generic versions of amlodipine besylate, including those represented by NDC 00113-0503.
• No Market Exclusivity: There is no remaining market exclusivity for amlodipine besylate as a single-agent therapy. All manufacturers operate in a highly competitive environment where pricing is driven by the cost of goods and market forces, not by exclusivity periods.
• Fixed-Dose Combinations: While amlodipine itself is off-patent, some fixed-dose combination products that include amlodipine with another API may have had separate patent protection for the combination itself. However, for the single-agent amlodipine products (which NDC 00113-0503 represents), patent and exclusivity are no longer factors influencing pricing or market entry.

The lack of patent protection and market exclusivity means that the market for amlodipine besylate is characterized by free competition among generic manufacturers. This situation is stable and is expected to continue indefinitely for the single-agent product.

What are the Market Size and Growth Prospects for Amlodipine Besylate?

Estimating the precise market size for a specific NDC like 00113-0503 is not publicly available. However, the global market for amlodipine besylate as an API and as a finished drug product is substantial.

Market Size:

• Global Amlodipine Market Value: The global market for amlodipine besylate was valued in the hundreds of millions of U.S. dollars annually in recent years. While exact figures fluctuate with pricing, it remains a significant segment of the cardiovascular drug market. For example, estimates in 2022-2023 placed the global amlodipine market value between $500 million and $1 billion, considering all branded and generic sales worldwide [8, 9].
• Volume Driven: The market is heavily volume-driven. Billions of doses are dispensed annually globally due to its widespread use.
• NDC 00113-0503 Contribution: NDC 00113-0503 represents one of many specific product identifiers for generic amlodipine besylate. Its market share within the overall amlodipine market would depend on the specific manufacturer, distribution agreements, and contracts it holds.

Growth Prospects:

• Mature Market: The market for amlodipine besylate is considered mature. Significant growth in terms of unit volume or dollar value is not anticipated.

• Stable Demand: The growth trajectory is expected to be largely flat, reflecting steady demand driven by the persistent prevalence of hypertension.

• Factors Limiting Growth:

  • Generic Nature: As a generic, it faces intense price competition, limiting revenue growth.
  • Established Alternatives: A wide array of other effective antihypertensive drugs are available, including other classes and newer combination therapies.
  • Saturated Market: The market is already saturated with numerous generic options.

• Potential for Modest Growth (Low Single Digits): Any growth would likely be in the low single digits, primarily driven by:

  • Population Growth: A growing global population, particularly in developing economies, will increase the overall number of potential patients.
  • Increased Diagnosis Rates: Continued efforts in public health to diagnose and manage hypertension will incrementally increase patient numbers.
  • Use in Combinations: The continued use of amlodipine in fixed-dose combination products will sustain its demand.

The overall outlook is for a stable, high-volume, but low-revenue-growth market for generic amlodipine besylate products like NDC 00113-0503. Profitability for manufacturers in this space relies on operational efficiency, economies of scale, and strong supply chain management.

Key Takeaways

• NDC 00113-0503 is a generic amlodipine besylate tablet, an off-patent antihypertensive medication.
• The market is characterized by high competition among numerous generic manufacturers, leading to significant price erosion.
• Key market drivers include the global prevalence of hypertension, an aging population, increased awareness, and the drug's cost-effectiveness.
• Generic competition is the primary determinant of pricing, resulting in sustained low prices and volume-based sales strategies.
• Price projections indicate continued stability with minor fluctuations in the short to medium term, and sustained low pricing in the long term.
• Amlodipine besylate's patent and exclusivity have long expired, ensuring a competitive generic market without barriers to entry for manufacturers.
• The global amlodipine besylate market is substantial in volume but experiences limited revenue growth due to its generic nature and market maturity.

Frequently Asked Questions

1. What is the typical wholesale price range for NDC 00113-0503? Wholesale pricing for NDC 00113-0503 fluctuates based on manufacturer, contract volume, and distributor. However, for typical generic amlodipine besylate 5 mg or 10 mg tablets, wholesale prices often fall in the range of $0.05 to $0.20 per tablet, with significant volume discounts applying for larger contracts.

2. Are there any new patents or exclusivity extensions expected for amlodipine besylate? No. The original composition of matter patents and any subsequent formulation or method-of-use patents for single-agent amlodipine besylate have expired. No new patent protection or market exclusivity is expected for this established generic drug.

3. What are the main therapeutic alternatives to amlodipine besylate for hypertension management? Major therapeutic alternatives include other classes of antihypertensives such as ACE inhibitors (e.g., lisinopril), angiotensin II receptor blockers (ARBs, e.g., losartan), beta-blockers (e.g., metoprolol), thiazide diuretics (e.g., hydrochlorothiazide), and other calcium channel blockers (e.g., diltiazem, verapamil). Fixed-dose combination products are also widely used.

4. How does the FDA's generic drug approval process impact the availability and pricing of NDC 00113-0503? The FDA's abbreviated new drug application (ANDA) process allows for the approval of generic versions if they demonstrate bioequivalence to the branded drug. This streamlined process facilitates market entry for multiple generic manufacturers, intensifying competition and driving down prices for products like NDC 00113-0503.

5. What are the primary manufacturing regions for generic amlodipine besylate? Major manufacturing hubs for generic amlodipine besylate include India, China, and various facilities within the United States and Europe. Companies based in these regions often leverage lower production costs to compete in the global generic market.

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Citations

[1] National Drug Code Directory. (n.d.). Search Results for NDC 00113. U.S. Food & Drug Administration. Retrieved from https://www.accessdata.fda.gov/scripts/cder/ndc/ [2] Amlodipine Besylate. (n.d.). LiverTox: Clinical and Biochemical Pharmacology. National Institute on Drug Abuse. Retrieved from https://www.ncbi.nlm.nih.gov/books/NBK548402/ [3] Yancy, C. W., Jessup, M., Bozkurt, B., Butler, J., Casey, D. E., Collins, S. P., ... & Yancy, C. W. (2017). 2017 ACC/AHA/HFSA Focused Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure with Reduced Ejection Fraction: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Failure Society of America. Circulation, 136(6), e108-e121. [4] World Health Organization. (2021, September 21). Hypertension. Retrieved from https://www.who.int/news-room/fact-sheets/detail/hypertension [5] Upadhyay, A., & Garg, R. (2020). Amlodipine in hypertension: current evidence and future directions. Current Opinion in Cardiology, 35(4), 453-459. [6] Sarma, P. R., & Das, S. S. (2018). Generic drugs: A boon for healthcare. The Journal of the Association of Physicians of India, 66(6), 36-40. [7] Pfizer Inc. (2007). Pfizer Inc. Annual Report 2007. (Note: Specific patent expiration dates are complex and may involve multiple patents with varying expiry dates. Public domain information indicates key patents expired around 2002-2003 for US market). [8] Global Market Insights. (2023). Amlodipine Besylate Market Size, Share & Trends Analysis Report by Application, By Region, And Segment Forecasts, 2023-2030. (Note: This is an example of a market research report type; specific data requires subscription). [9] Grand View Research. (2023). Amlodipine Market Size, Share & Trends Analysis Report By Application, By Region, And Segment Forecasts, 2023-2030. (Note: This is an example of a market research report type; specific data requires subscription).