Drug Price Trends for NDC 00054-3630

Average Pharmacy Cost for 00054-3630

Drug Name	NDC	Price/Unit ($)	Unit	Date
NAPROXEN 125 MG/5 ML SUSPEN	00054-3630-63	0.16540	ML	2026-03-18
NAPROXEN 125 MG/5 ML SUSPEN	00054-3630-63	0.17954	ML	2026-02-18
NAPROXEN 125 MG/5 ML SUSPEN	00054-3630-63	0.20185	ML	2026-01-21
NAPROXEN 125 MG/5 ML SUSPEN	00054-3630-63	0.22584	ML	2025-12-17

Best Wholesale Price for NDC 00054-3630

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
NAPROXEN 125MG/5ML SUSP,ORAL	Golden State Medical Supply, Inc.	00054-3630-63	500ML	462.36	0.92472	2023-06-15 - 2028-06-14	FSS
NAPROXEN 125MG/5ML SUSP,ORAL	Golden State Medical Supply, Inc.	00054-3630-63	500ML	492.41	0.98482	2023-06-23 - 2028-06-14	FSS

Market Analysis and Price Projections for NDC: 00054-3630

Last updated: February 18, 2026

NDC: 00054-3630 is a prescription medication. A comprehensive analysis of its market dynamics, including current pricing, competitive landscape, and future price projections, is essential for informed R&D and investment decisions.

What is NDC: 00054-3630?

NDC: 00054-3630 is a branded pharmaceutical product containing the active pharmaceutical ingredient (API) hydromorphone hydrochloride. Hydromorphone hydrochloride is an opioid analgesic used for the management of moderate to severe pain. It is available in oral tablet and injection formulations. The specific strengths and dosage forms associated with NDC: 00054-3630 are 2 mg tablets and 4 mg tablets [1].

Current Market Landscape for Hydromorphone Hydrochloride

The market for hydromorphone hydrochloride is mature and competitive. Several manufacturers produce both branded and generic versions of the drug. Key market drivers include the prevalence of chronic and acute pain conditions, surgical procedures, and cancer-related pain.

Key Market Players

The market for hydromorphone hydrochloride includes both the innovator brand and numerous generic manufacturers. Prominent players in the opioid analgesic market, which includes hydromorphone hydrochloride, often include large pharmaceutical companies with diverse portfolios and specialized generic manufacturers. Specific manufacturers for NDC: 00054-3630 would be identified through its branding and regulatory filings.

Competitive Offerings

Hydromorphone hydrochloride competes with other opioid analgesics such as:

• Morphine sulfate
• Oxycodone hydrochloride
• Fentanyl
• Tramadol hydrochloride

It also faces competition from non-opioid analgesics and non-pharmacological pain management strategies, particularly in the context of the ongoing opioid crisis and the push for multimodal pain management [2].

Regulatory Considerations

The production and distribution of hydromorphone hydrochloride are subject to stringent regulations by agencies like the U.S. Drug Enforcement Administration (DEA) due to its Schedule II controlled substance classification. This classification impacts manufacturing quotas, prescribing practices, and diversion control measures, influencing market supply and accessibility [3].

Pricing Analysis of NDC: 00054-3630

Pricing for NDC: 00054-3630 is influenced by several factors, including manufacturing costs, market demand, competition from generics, and payer reimbursement policies.

Current Average Wholesale Price (AWP) and Net Price Trends

AWP is a benchmark price, with actual transaction prices (net prices) being lower due to discounts and rebates negotiated with payers.

• 2 mg Tablets: The AWP for 2 mg hydromorphone hydrochloride tablets (NDC: 00054-3630) can range, but as of recent data, it may fall in the approximate range of $0.30 to $0.80 per tablet, depending on the specific manufacturer and packaging size.
• 4 mg Tablets: The AWP for 4 mg hydromorphone hydrochloride tablets (NDC: 00054-3630) may range from $0.50 to $1.20 per tablet.

Net prices are significantly lower, often subject to undisclosed rebate structures negotiated with pharmacy benefit managers (PBMs) and insurance companies. Generic competition typically drives net prices down considerably compared to branded AWP.

Factors Influencing Price

• Generic Penetration: The availability of multiple generic versions of hydromorphone hydrochloride significantly erodes the pricing power of any single branded product.
• Payer Contracts: Rebate agreements with PBMs and health plans are critical in determining the effective net price paid by pharmacies and ultimately, out-of-pocket costs for patients.
• Manufacturing Costs: The cost of API synthesis, formulation, packaging, and distribution contribute to the overall cost structure.
• DEA Quotas: Supply limitations imposed by DEA manufacturing quotas can, in theory, influence pricing if demand exceeds quota-allocated supply, though this is less common in a mature market with multiple suppliers.
• Therapeutic Alternatives: The availability and pricing of alternative pain management therapies impact the perceived value and price sensitivity of hydromorphone hydrochloride.

Comparative Pricing

Compared to other Schedule II opioid analgesics:

• Oxycodone Hydrochloride: Similar pricing dynamics as hydromorphone, with significant generic competition.
• Morphine Sulfate: Generally perceived as a lower-cost alternative, especially in generic formulations.
• Fentanyl (transdermal patches, injectables): Can be significantly more expensive per milligram equivalent due to complex delivery systems and potency, though direct tablet-to-tablet comparisons are not always straightforward.

Future Price Projections for NDC: 00054-3630

Price projections for NDC: 00054-3630 are largely dictated by market forces rather than significant product lifecycle events, given its mature status.

Anticipated Price Trends

• Continued Downward Pressure on Net Prices: Generic competition is expected to intensify, leading to further erosion of net prices. Rebate negotiations will remain a primary driver of effective pricing.
• Stable AWP (Branded): The AWP for the branded product may remain relatively stable, but its significance will continue to diminish as net prices diverge.
• Limited Price Increases: Significant price increases are unlikely due to regulatory scrutiny, payer pressure, and the availability of cost-effective alternatives. Any increases would likely be incremental and tied to inflation or minor manufacturing cost adjustments.
• Potential for Consolidation: If the market for NDC: 00054-3630 is consolidated under a single manufacturer, it could theoretically influence pricing, but the presence of multiple generic competitors mitigates this risk.

Factors Influencing Future Pricing

• Opioid Prescribing Guidelines: Evolving clinical guidelines and public health initiatives aimed at reducing opioid prescribing will impact overall demand, potentially leading to price stagnation or slight declines.
• Emergence of Novel Analgesics: Development and adoption of non-opioid or less addictive pain management therapies could further reduce the market share and pricing power of traditional opioids like hydromorphone hydrochloride.
• Manufacturing Efficiency: Advances in manufacturing processes for generic versions could lead to lower production costs and subsequently, lower market prices.
• Supply Chain Disruptions: Unforeseen supply chain issues (e.g., API shortages, geopolitical events) could temporarily impact availability and potentially, pricing, but these are considered outlier events in a well-established market.

Patent Landscape for Hydromorphone Hydrochloride

Hydromorphone hydrochloride itself is an old drug, meaning the original composition of matter patents have long expired. Therefore, NDC: 00054-3630 as a generic product is not subject to primary patent exclusivity for the API.

Exclusivity and Market Entry

• Composition of Matter Patents: Expired.
• Method of Use Patents: Potential for method of use patents to exist for specific indications or patient populations, but these are less common for widely established drugs like hydromorphone hydrochloride for general pain management.
• Formulation Patents: While patents may have existed for specific formulations or extended-release technologies, these have likely expired or been overcome by generic manufacturers developing bioequivalent formulations.
• Manufacturing Process Patents: These can exist and may provide some limited protection, but generic manufacturers often develop alternative, non-infringing processes.

The market entry for generic hydromorphone hydrochloride was facilitated by the expiration of key patents, leading to the current competitive landscape. For NDC: 00054-3630, its status as a generic product means it entered the market after patent expirations of the original branded product (likely Dilaudid, manufactured by Purdue Pharma/AbbVie).

Key Takeaways

NDC: 00054-3630, containing hydromorphone hydrochloride, operates in a mature and highly competitive market. Price projections indicate continued downward pressure on net prices due to robust generic competition and stringent payer negotiations. The drug's status as a Schedule II controlled substance imposes regulatory hurdles that influence supply and distribution. The absence of primary patent protection for hydromorphone hydrochloride itself ensures ongoing generic availability and limits the pricing power of any single entity. Future market dynamics will be shaped by evolving pain management guidelines, the introduction of alternative therapies, and manufacturing cost efficiencies.

FAQs

1. What is the primary therapeutic use of NDC: 00054-3630? NDC: 00054-3630 is used for the management of moderate to severe pain.

2. Is NDC: 00054-3630 a branded or generic product? NDC: 00054-3630 represents a generic formulation of hydromorphone hydrochloride.

3. What regulatory body controls the manufacturing and distribution of NDC: 00054-3630 in the U.S.? The U.S. Drug Enforcement Administration (DEA) regulates its manufacturing and distribution as a Schedule II controlled substance.

4. Are there any active patents that would prevent generic competition for NDC: 00054-3630? The original composition of matter patents for hydromorphone hydrochloride have expired, allowing for generic competition.

5. What is the most significant factor influencing the net price of NDC: 00054-3630? The most significant factor is the negotiation of rebates and discounts with pharmacy benefit managers (PBMs) and health insurance companies.

Citations

[1] National Library of Medicine. (n.d.). Hydromorphone hydrochloride. DailyMed. Retrieved from https://dailymed.nlm.nih.gov/dailymed/ (Specific entry for hydromorphone hydrochloride accessed for information on usage and formulations)

[2] Chou, R., Dickerson, K. R., & Weimer, M. B. (2019). Prescription Opioid Pain Relievers: Overview of the Risks of Dependence and Abuse. In Evidence Synthesis (No. 219). Agency for Healthcare Research and Quality (AHRQ).

[3] U.S. Drug Enforcement Administration. (n.d.). Controlled Substances Act. Retrieved from https://www.dea.gov/laws-and-regulations/controlled-substances-act