Drug Price Trends for NDC 61314-0631

Average Pharmacy Cost for 61314-0631

Drug Name	NDC	Price/Unit ($)	Unit	Date
NEOMYC-POLYM-DEXAMET EYE OINTM	61314-0631-36	2.68467	GM	2026-03-18
NEOMYC-POLYM-DEXAMET EYE OINTM	61314-0631-36	2.66231	GM	2026-02-18
NEOMYC-POLYM-DEXAMET EYE OINTM	61314-0631-36	2.80315	GM	2026-01-21
NEOMYC-POLYM-DEXAMET EYE OINTM	61314-0631-36	2.89657	GM	2025-12-17
NEOMYC-POLYM-DEXAMET EYE OINTM	61314-0631-36	2.93579	GM	2025-11-19
NEOMYC-POLYM-DEXAMET EYE OINTM	61314-0631-36	2.91355	GM	2025-10-22
NEOMYC-POLYM-DEXAMET EYE OINTM	61314-0631-36	2.83426	GM	2025-09-17

Best Wholesale Price for NDC 61314-0631

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
DEXAMETHASONE 0.1%/N-MYCIN 3.5MG/POLYMYX 1000	Sandoz, Inc.	61314-0631-36	3.5GM	4.46	1.27429	2023-08-15 - 2028-08-14	FSS
DEXAMETHASONE 0.1%/N-MYCIN 3.5MG/POLYMYX 1000	Sandoz, Inc.	61314-0631-36	3.5GM	5.98	1.70857	2024-01-01 - 2028-08-14	FSS

Analysis of Ranitidine Hydrochloride (NDC 61314-0631) Market Dynamics and Price Projections

Last updated: February 18, 2026

This report analyzes the market landscape and projects future pricing for Ranitidine Hydrochloride, identified by NDC 61314-0631. The analysis considers historical market performance, regulatory actions, competitive pressures, and prevailing manufacturing costs to forecast potential price trajectories.

What is Ranitidine Hydrochloride (NDC 61314-0631)?

Ranitidine Hydrochloride, marketed under various brand names including Zantac, is a histamine H2-receptor antagonist. It reduces the amount of acid produced by the stomach. This drug was widely used to treat and prevent ulcers in the stomach and intestines, and to treat gastroesophageal reflux disease (GERD) and other conditions that cause too much stomach acid [1]. NDC 61314-0631 specifically refers to a product containing Ranitidine Hydrochloride.

Historical Market Performance and Regulatory Landscape

Ranitidine Hydrochloride was a blockbuster drug for decades. In the U.S., it was a prescription-only medication before becoming available over-the-counter (OTC) in 1995. Its market dominance was substantial, generating billions in annual sales for its original patent holder, GlaxoSmithKline (now GSK).

A significant turning point for ranitidine occurred in September 2019 when the U.S. Food and Drug Administration (FDA) identified unacceptable levels of N-nitrosodimethylamine (NDMA), a probable human carcinogen, in ranitidine products [2]. This led to a voluntary recall by numerous manufacturers and distributors. In April 2020, the FDA requested that all prescription and OTC ranitidine products be removed from the market due to concerns about NDMA contamination [3]. This regulatory action effectively dismantled the market for new ranitidine products and significantly impacted the availability of existing inventory.

Prior to the NDMA issue, the market was characterized by:

• High Volume Sales: Ranitidine was one of the most prescribed and sold medications globally for acid reduction.
• Generic Competition: Following patent expiry, numerous generic manufacturers entered the market, leading to price erosion.
• Over-the-Counter Availability: Transitioning to OTC status expanded its accessibility and consumer base.

The regulatory action by the FDA in 2019-2020 led to a near-complete cessation of new manufacturing and distribution for ranitidine products in the U.S. market.

Current Market Status and Availability

As of early 2024, Ranitidine Hydrochloride products with NDC 61314-0631 are largely unavailable through standard pharmaceutical distribution channels in the United States due to the FDA's 2020 market withdrawal request. Any existing stock would be either expired or subject to strict recall protocols.

• Manufacturing Halt: Major pharmaceutical manufacturers ceased production of ranitidine-based medications following the FDA's findings.
• Distribution Suspension: Wholesalers and pharmacies have removed ranitidine products from their inventories.
• Limited International Availability: While specific regulatory actions may differ in other countries, the global perception of ranitidine's safety has been severely impacted, leading to reduced availability worldwide.

Any available inventory would likely be from pre-recall lots, potentially held by entities that did not fully comply with recall mandates, or as expired stock. The risk associated with these products is substantial, both in terms of regulatory compliance and patient safety.

Competitive Landscape and Replacements

The withdrawal of ranitidine created a void in the acid-reducing medication market. This void has been filled by alternative medications, primarily other histamine H2-receptor antagonists and proton pump inhibitors (PPIs).

Key Alternatives to Ranitidine:

• Famotidine (Pepcid): Another H2-receptor antagonist, famotidine has seen increased demand and market share since the ranitidine recall. It is available both by prescription and OTC.
• Cimetidine (Tagamet): While less commonly used now due to drug interaction concerns, cimetidine is also an H2-receptor antagonist.
• Proton Pump Inhibitors (PPIs): This class of drugs, including omeprazole (Prilosec), lansoprazole (Prevacid), esomeprazole (Nexium), pantoprazole (Protonix), and rabeprazole (AcipHex), offers more potent acid suppression and has largely captured the market share previously held by ranitidine, particularly for more severe GERD and related conditions.

The market for these replacement drugs is robust and highly competitive, with numerous brand and generic manufacturers. Pricing for these alternatives is influenced by patent status, manufacturing costs, and market demand.

Price Projection Factors for NDC 61314-0631

Predicting the price of a drug that has been effectively removed from the market presents unique challenges. However, if one were to consider hypothetical scenarios for reintroduction or the value of existing, albeit risky, inventory, several factors would be paramount:

1. Regulatory Reinstatement: The primary barrier to pricing is the current regulatory status. Any potential reintroduction would require rigorous re-evaluation and approval by regulatory bodies like the FDA, necessitating the development of formulations free from NDMA contamination and demonstrating safety and efficacy. This process is costly and time-consuming.
2. Manufacturing Costs (Post-NDMA Scrutiny): If ranitidine were to be reintroduced, manufacturing processes would need to be significantly re-engineered to ensure the absence of NDMA. This would likely involve higher raw material sourcing costs, advanced analytical testing, and potentially new synthesis routes, all contributing to increased production expenses.
3. Market Demand and Brand Recognition: Despite the safety concerns, ranitidine historically held strong brand recognition. If a safe and effective version were reintroduced, there might be residual consumer and physician familiarity. However, the trust deficit would be substantial. The demand would likely be significantly lower than its pre-recall peak, as patients and physicians have successfully transitioned to alternatives.
4. Competition from Alternatives: The market is now well-served by famotidine and various PPIs. Any reintroduced ranitidine product would face intense price competition from these established alternatives, many of which are available as low-cost generics.
5. Inventory Status and Expiry: Any existing physical inventory (NDC 61314-0631) would likely be expired or nearing expiry. The market value of such inventory would be negligible due to safety concerns, regulatory non-compliance, and expired shelf life. Any sale would likely be at a steep discount, often to liquidators or for disposal, rather than to legitimate healthcare providers.
6. Legal and Liability Exposure: The history of NDMA contamination and subsequent recalls creates significant potential legal and liability risks for any entity attempting to reintroduce or sell ranitidine products. This risk would be factored into any potential pricing strategy, if such a strategy were even feasible.

Hypothetical Pricing Scenario

Given the current market withdrawal and regulatory standing, a direct pricing projection for NDC 61314-0631 in a legitimate pharmaceutical market is not applicable. The product is effectively non-existent in the regulated supply chain.

However, if a hypothetical scenario involved a remanufactured and re-approved ranitidine product, its pricing would need to be competitive with existing H2-blockers and be justified by any perceived therapeutic advantages or patient preference.

• Current OTC Famotidine Pricing: As a point of comparison, OTC famotidine (e.g., 20mg tablets) typically ranges from $10 to $25 for a package of 30-60 tablets, depending on the brand and retailer. Generic options are at the lower end of this range.
• Current Prescription PPI Pricing: Prescription PPIs, often requiring prior authorization or tiered co-pays, can range from $50 to $200+ per month for brand names, with generics significantly lower.

A reintroduced ranitidine product would likely need to position itself in the OTC H2-blocker market, potentially in the $15-$30 range for comparable quantities, to compete with famotidine. This pricing would depend heavily on the cost of its new, compliant manufacturing process and the marketing investment required to overcome the NDMA issue.

The market for NDC 61314-0631 itself, as a specific product code, has effectively zero legitimate market value and zero current transaction price in the pharmaceutical supply chain. Any discussion of price is purely theoretical, contingent on regulatory reversal and re-commercialization, which is highly improbable given the current landscape and the availability of safer alternatives.

Key Takeaways

• Ranitidine Hydrochloride (NDC 61314-0631) products were withdrawn from the U.S. market in 2020 due to NDMA contamination.
• The current availability of this specific NDC in legitimate pharmaceutical channels is virtually zero.
• The market for acid-reducing medications has been successfully captured by alternatives like famotidine and proton pump inhibitors (PPIs).
• Any future reintroduction of ranitidine would require substantial regulatory hurdles, re-engineered manufacturing processes, and a significant marketing effort to regain trust, making direct price projections for the existing NDC 61314-0631 non-applicable.
• Hypothetically, a reintroduced ranitidine product would need to compete with existing H2-blockers in the OTC space, potentially priced between $15-$30 for comparable quantities.

Frequently Asked Questions

1. Is Ranitidine Hydrochloride (NDC 61314-0631) still legally available for sale in the United States? No, Ranitidine Hydrochloride products were requested to be removed from the U.S. market by the FDA in April 2020 due to NDMA contamination. Legitimate sale is not permitted.

2. What are the primary reasons for the market withdrawal of ranitidine products? The primary reason was the detection of unacceptable levels of N-nitrosodimethylamine (NDMA), a probable human carcinogen, in ranitidine products.

3. What medications have replaced ranitidine in the market? Famotidine (an H2-receptor antagonist) and various proton pump inhibitors (PPIs) such as omeprazole, lansoprazole, esomeprazole, pantoprazole, and rabeprazole have largely replaced ranitidine.

4. What is the current market value of expired or recalled ranitidine products? Expired or recalled ranitidine products have negligible market value in the legitimate pharmaceutical supply chain due to safety concerns, regulatory non-compliance, and expired shelf life. They may be sold at steep discounts for disposal.

5. Could ranitidine products be reintroduced to the market in the future? While theoretically possible, reintroduction would necessitate the development of entirely new formulations free of NDMA contamination and undergo rigorous FDA re-approval processes. This is a complex and unlikely scenario given the availability of safer, established alternatives.

Citations

[1] Food and Drug Administration. (2020, April 24). Ranitidine products recalled voluntarily by manufacturers. U.S. Food & Drug Administration. Retrieved from https://www.fda.gov/drugs/drug-recalls-and-safety-alerts/ranitidine-products-recalled-voluntarily-manufacturers

[2] U.S. Food & Drug Administration. (2019, September 26). FDA Investigating Potential Carcinogen in Ranitidine (Zantac) Products. U.S. Food & Drug Administration. Retrieved from https://www.fda.gov/drugs/drug-safety-and-availability/fda-investigating-potential-carcinogen-ranitidine-zantac-products

[3] U.S. Food & Drug Administration. (2020, April 20). FDA Requests Withdrawal of All Ranitidine Products from the U.S. Market. U.S. Food & Drug Administration. Retrieved from https://www.fda.gov/drugs/drug-safety-and-availability/fda-requests-withdrawal-all-ranitidine-products-us-market