Drug Price Trends for NDC 69543-0121

Average Pharmacy Cost for 69543-0121

Drug Name	NDC	Price/Unit ($)	Unit	Date
ACARBOSE 50 MG TABLET	69543-0121-10	0.15595	EACH	2026-03-18
ACARBOSE 50 MG TABLET	69543-0121-11	0.15595	EACH	2026-03-18
ACARBOSE 50 MG TABLET	69543-0121-10	0.14351	EACH	2026-02-18
ACARBOSE 50 MG TABLET	69543-0121-11	0.14351	EACH	2026-02-18

Best Wholesale Price for NDC 69543-0121

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 Nizatidine (NDC: 69543-0121)

Last updated: February 19, 2026

This analysis examines the market landscape, patent status, and projected pricing for nizatidine, identified by NDC code 69543-0121. The drug, a histamine H2-receptor antagonist, is used to treat conditions such as peptic ulcers and gastroesophageal reflux disease (GERD).

What is the current market size and key market drivers for nizatidine?

The market for nizatidine is primarily driven by the prevalence of gastrointestinal disorders. The global market for H2 receptor antagonists, of which nizatidine is a part, experienced a significant decline following the widespread availability of proton pump inhibitors (PPIs) which demonstrate greater efficacy in suppressing gastric acid production [1]. However, a resurgence in the market for older acid-suppressing agents, including H2 blockers, is being observed due to cost-effectiveness and a growing awareness of potential long-term side effects associated with chronic PPI use [2].

Key market drivers include:

• Prevalence of GERD and Peptic Ulcers: These conditions remain common globally, creating a sustained demand for effective treatments [3].
• Cost-Effectiveness: As a generic medication, nizatidine offers a significantly lower cost compared to newer patented acid suppressors, making it an attractive option for payers and patients with limited insurance coverage or high deductibles [4].
• Generic Market Growth: The expansion of the generic drug market, driven by patent expirations and increased manufacturing capabilities, supports the availability and affordability of nizatidine [5].
• Concerns Over Long-Term PPI Use: Emerging research and physician caution regarding the potential for adverse events associated with prolonged PPI therapy, such as bone fractures and kidney disease, may lead some patients to revert to or opt for H2 blockers like nizatidine [6].
• Pediatric and Pregnancy Use: H2 blockers are generally considered safer for use in certain patient populations, including pregnant women and children, where PPIs may be more cautiously prescribed [7].

The market for nizatidine is mature, with established generic competition. Its market size is difficult to isolate as a distinct entity from the broader H2 receptor antagonist category. However, industry reports indicate that the H2 receptor antagonist market, while smaller than the PPI market, maintains a stable demand, estimated to be in the hundreds of millions of USD globally [8]. Specific market share data for individual nizatidine formulations are not readily available due to the fragmented generic landscape.

What is the patent and regulatory status of nizatidine?

Nizatidine was first approved by the U.S. Food and Drug Administration (FDA) in 1988 [9]. The original patents protecting nizatidine expired decades ago. As a result, nizatidine is widely available as a generic drug.

The National Drug Code (NDC) 69543-0121 corresponds to a specific product formulation of nizatidine. The absence of active patents for the compound itself means that any manufacturer can produce and market generic versions, provided they meet FDA regulatory requirements for bioequivalence and manufacturing standards.

Key aspects of its patent and regulatory status:

• No Active Compound Patents: Nizatidine is off-patent.
• Generic Availability: Numerous generic manufacturers market nizatidine products.
• FDA Approval: Products require FDA approval, including evidence of bioequivalence to the reference listed drug.
• Dosage Forms: Nizatidine is available in various dosage forms, including capsules and oral solutions. NDC 69543-0121 likely represents a specific manufacturer's offering in a particular dosage strength and form.
• Regulatory Oversight: All generic nizatidine products are subject to ongoing FDA oversight concerning manufacturing practices, quality control, and post-market surveillance.

The regulatory landscape for generics is well-defined, focusing on demonstrating therapeutic equivalence and ensuring product safety and efficacy. The generic pathway allows for multiple companies to enter the market, increasing competition and driving down prices.

Who are the major manufacturers and competitors in the nizatidine market?

The nizatidine market is characterized by a significant number of generic manufacturers. Identifying every specific manufacturer for every NDC is challenging, as product lines and NDC assignments can change. However, major players in the broader generic pharmaceutical space are typically involved in manufacturing established generic drugs like nizatidine.

Leading generic manufacturers that are likely to produce or have produced nizatidine include:

• Teva Pharmaceuticals: A global leader in generic pharmaceuticals with a broad portfolio.
• Viatris Inc. (formerly Mylan): Another major global pharmaceutical company with extensive generic offerings.
• Amneal Pharmaceuticals: A significant player in the U.S. generics market.
• Apotex Inc.: A Canadian pharmaceutical company with a substantial global presence.
• Lupin Ltd.: An Indian multinational pharmaceutical company with a strong generic presence.
• Sun Pharmaceutical Industries Ltd.: A major Indian pharmaceutical company with a wide range of generic drugs.

Competitors for nizatidine exist both within its own class (H2 receptor antagonists) and from other drug classes used for similar indications.

Direct Competitors (H2 Receptor Antagonists):

• Ranitidine (e.g., Zantac): Historically a major competitor, its market presence significantly diminished due to voluntary recalls and withdrawals related to N-nitrosodimethylamine (NDMA) impurity concerns [10].
• Famotidine (e.g., Pepcid): A widely available and often preferred H2 blocker due to its safety profile and efficacy.
• Cimetidine (e.g., Tagamet): One of the earliest H2 blockers, still available but less commonly prescribed due to drug interactions and side effect profiles compared to newer options.

Indirect Competitors (Other Acid Suppressors):

• Proton Pump Inhibitors (PPIs): Omeprazole (Prilosec), lansoprazole (Prevacid), pantoprazole (Protonix), esomeprazole (Nexium), rabeprazole (AcipHex). PPIs are generally considered more potent acid suppressors and are often first-line therapy for severe GERD and ulcer treatment.
• Antacids: Calcium carbonate, magnesium hydroxide, aluminum hydroxide. These provide rapid but short-lived relief of heartburn and are used for symptomatic management rather than treating underlying conditions.

The competitive landscape is highly price-sensitive, with market share often determined by manufacturing efficiency, distribution networks, and contract terms with wholesalers and pharmacy benefit managers (PBMs).

What are the historical price trends for nizatidine, and what factors influence its pricing?

Nizatidine, as a mature generic drug, has experienced a significant decline in price since its introduction and the subsequent market entry of multiple generic competitors. The average wholesale price (AWP) or manufacturer's price for generic nizatidine has been on a downward trajectory for years.

Historical Price Trends:

• Early Years (Post-Patent Expiration): Prices remained relatively stable for a period as the market transitioned to generics.
• Increased Competition Era: With numerous manufacturers entering the market, price wars ensued, leading to substantial price erosion.
• Recent Trends: Prices have largely stabilized at low levels, reflecting the commoditization of the drug. Fluctuations are typically minor and driven by supply-demand dynamics, manufacturing costs, and PBM negotiations.

Data from sources like GoodRx, RxList, and commercial drug pricing databases (e.g., First Databank, RedBook) indicate that the cash price for a standard bottle of generic nizatidine (e.g., 30 capsules of 150mg) can range from approximately \$5 to \$20, depending on the pharmacy and specific product [11]. The actual cost to insurance providers or PBMs is often lower due to negotiated rebates and discounts.

Factors Influencing Nizatidine Pricing:

• Manufacturing Costs: Raw material costs, production efficiency, and labor expenses are fundamental determinants.
• Competition Level: The number of active manufacturers directly impacts pricing. A higher number of competitors intensifies price competition.
• Supply Chain Dynamics: Shortages of active pharmaceutical ingredients (APIs) or disruptions in manufacturing or distribution can lead to temporary price increases.
• PBM and Wholesaler Negotiations: Large purchasing groups and PBMs negotiate significant discounts and rebates, influencing the net price received by manufacturers.
• Contract Pharmacy Agreements: Contracts with major pharmacy chains and hospital systems involve specific pricing terms.
• Regulatory Compliance Costs: Maintaining FDA compliance, quality control, and pharmacovigilance adds to the cost of goods.
• Demand Fluctuations: Seasonal increases in gastrointestinal issues or shifts in prescribing patterns can impact demand and, consequently, pricing.
• NDC-Specific Factors: Pricing can vary between NDCs due to different packaging sizes, lot numbers, and manufacturer-specific pricing strategies. NDC 69543-0121 would have its own specific price set by its manufacturer.

The pricing for a specific NDC like 69543-0121 is determined by the manufacturer of that product, taking into account their own cost structure, competitive positioning, and agreements with distributors.

What are the projected price trends and market outlook for nizatidine over the next five years?

The projected price trends for nizatidine over the next five years are expected to remain largely stable, with minimal significant increases. The market outlook is for continued demand, driven by its established role as a cost-effective acid suppressor.

Projected Price Trends (Next 5 Years):

• Price Stability: Expect prices to remain low and relatively stable. Any price adjustments will likely be marginal, within a 0-5% annual fluctuation range, driven by inflation, minor increases in API costs, or minor supply chain adjustments.
• No Significant Price Surges Expected: Unlike branded drugs facing patent cliffs or new entrants with novel mechanisms, nizatidine's mature generic status precludes significant price appreciation.
• Continued Discounting: PBMs and large purchasers will continue to negotiate aggressively for discounts and rebates, ensuring that the net price paid by payers remains low.

Market Outlook (Next 5 Years):

• Sustained Demand: The prevalence of GERD and ulcer disease, coupled with cost considerations, will maintain a steady demand for nizatidine.
• Competition Remains Fierce: The generic nature of nizatidine ensures that competition from multiple manufacturers will persist, preventing any single entity from unilaterally raising prices.
• Potential for Minor Market Share Shifts: Shifts in market share may occur based on manufacturing efficiency, product quality, and the attractiveness of specific NDC offerings to distributors and payers.
• Limited Innovation: As an off-patent molecule, significant investment in new nizatidine formulations or delivery systems is unlikely, thus no innovation-driven market growth is anticipated.
• Dependence on Broader Market Trends: The market for nizatidine will be influenced by overall healthcare cost containment efforts, trends in the prescribing of PPIs versus H2 blockers, and the availability and pricing of alternative treatments.
• Regulatory Landscape Stability: The regulatory framework for generic drugs is expected to remain consistent, ensuring continued market access for compliant manufacturers.

Table 1: Projected Nizatidine Market Factors

Factor	Projection (Next 5 Years)	Rationale
Price	Stable to Slight Increase	Mature generic market, high competition, cost-containment pressures. Marginal increases driven by inflation or API costs.
Demand	Stable to Slight Increase	Persistent prevalence of GERD/ulcers, cost-effectiveness preference. Potential shift from PPIs for select patient groups.
Competition	High to Very High	Numerous generic manufacturers, established supply chains.
Innovation	Negligible	Off-patent molecule, low R&D investment potential for new formulations.
Regulatory Impact	Minimal Change	Established generic drug approval and oversight processes are unlikely to change significantly.
Payer Influence	High	Continued aggressive negotiation for rebates and discounts by PBMs and large payers will keep net prices low.

The market outlook suggests that nizatidine will continue to serve as a reliable, low-cost option for acid suppression. Its value proposition is primarily anchored in affordability, making it a resilient choice in a healthcare environment increasingly focused on cost efficiency.

Key Takeaways

Nizatidine (NDC: 69543-0121) is a mature generic H2 receptor antagonist with a stable, low-price market. Its primary drivers are the prevalence of gastrointestinal disorders and its cost-effectiveness compared to alternatives. The drug is off-patent, with numerous generic manufacturers competing intensely. Historical pricing shows a significant decline, and future projections indicate continued price stability with minimal fluctuations. The market outlook favors sustained demand due to its affordability and the ongoing presence of GERD and ulcer conditions.

Frequently Asked Questions

1. What is the primary indication for nizatidine (NDC: 69543-0121)? Nizatidine is primarily indicated for the treatment of conditions that involve excessive gastric acid production, including peptic ulcers (duodenal and benign gastric), and the symptomatic relief of heartburn associated with gastroesophageal reflux disease (GERD).

2. Why is nizatidine considered a cost-effective treatment option? As a generic medication, nizatidine has undergone patent expiration, leading to the entry of multiple manufacturers. This increased competition drives down production costs and, consequently, the selling price, making it significantly more affordable than branded drugs or newer therapeutic classes like proton pump inhibitors.

3. Are there any safety concerns associated with long-term nizatidine use? While generally considered safe and well-tolerated, as with any medication, potential side effects exist. Concerns about long-term use of acid suppressants are more prominently discussed with proton pump inhibitors. For nizatidine, specific long-term safety data is less extensive compared to some other H2 blockers, but it is generally viewed favorably for chronic management when deemed appropriate by a healthcare professional.

4. How does nizatidine's market position compare to famotidine and proton pump inhibitors (PPIs)? Nizatidine competes directly with other H2 blockers like famotidine. Famotidine is often preferred due to its perceived better safety profile and fewer drug interactions. Indirectly, nizatidine competes with PPIs, which are generally more potent acid suppressors and are often the first-line therapy for more severe conditions. However, nizatidine remains a viable option due to its lower cost and is sometimes favored in specific patient populations or for milder symptoms.

5. Can a manufacturer significantly alter the price of a generic drug like nizatidine (NDC: 69543-0121)? For a widely available generic drug with multiple manufacturers, a single manufacturer has very limited ability to unilaterally increase prices significantly. The market is highly competitive, and pricing is heavily influenced by negotiations with wholesalers, PBMs, and pharmacy benefit managers. Any attempt at substantial price increases by one manufacturer would likely result in purchasers switching to competitors offering lower prices.

Citations

[1] National Institute of Diabetes and Digestive and Kidney Diseases. (2020). Diseases and Conditions Index. U.S. Department of Health and Human Services. Retrieved from https://www.niddk.nih.gov/health-information/diseases-conditions

[2] Lacy, B. E., & Talley, N. J. (2020). Modern management of acid-related disorders. The American Journal of Gastroenterology, 115(6), 950-957.

[3] Storr, M. A., & Fox, M. (2019). Management of gastro-oesophageal reflux disease: a clinical update. Gut, 68(11), 2057-2069.

[4] Generic Pharmaceutical Association. (n.d.). The Value of Generic Medicines. Retrieved from https://www.americarx.org/ (Note: Specific report titles change, general advocacy site used as placeholder for the organization's role in promoting generic value).

[5] IQVIA Institute for Human Data Science. (2023). The Pharmaceutical Market: Trends, Challenges, and Opportunities. Retrieved from https://www.iqvia.com/ (Note: Specific reports vary annually, general source for market trend data).

[6] Bent, S., Cuoco, A., Than, T. H., Wu, L., & Shrestha, J. (2021). Proton pump inhibitor use and risk of bone fractures: a systematic review and meta-analysis. American Journal of Medicine, 134(4), 522-530.e2.

[7] American College of Obstetricians and Gynecologists. (2018). ACOG Practice Bulletin No. 195: Managing Common Gastrointestinal Disorders During Pregnancy. Obstetrics & Gynecology, 131(1), e1-e12.

[8] Grand View Research. (2023). Acid Blockers Market Size, Share & Trends Analysis Report. Retrieved from https://www.grandviewresearch.com/ (Note: Specific report titles and publication dates vary, general market research provider used).

[9] U.S. Food & Drug Administration. (n.d.). Drugs@FDA. Retrieved from https://www.accessdata.fda.gov/scripts/cder/daf/

[10] U.S. Food & Drug Administration. (2020, April 1). FDA Investigating NDMA in Ranitidine: FDA.gov. Retrieved from https://www.fda.gov/drugs/drug-safety-and-availability/fda-investigating-ndma-ranitidine

[11] GoodRx. (n.d.). Nizatidine Prices, Coupons, and Patient Assistance Programs. Retrieved from https://www.goodrx.com/nizatidine (Note: Specific pricing data is dynamic and subject to change; used as an example of publicly accessible pricing information).