Drug Price Trends for NDC 00904-5891

Average Pharmacy Cost for 00904-5891

Drug Name	NDC	Price/Unit ($)	Unit	Date
PRAVASTATIN SODIUM 10 MG TAB	00904-5891-61	0.05998	EACH	2026-03-18
PRAVASTATIN SODIUM 10 MG TAB	00904-5891-61	0.06181	EACH	2026-02-18
PRAVASTATIN SODIUM 10 MG TAB	00904-5891-61	0.06419	EACH	2026-01-21
PRAVASTATIN SODIUM 10 MG TAB	00904-5891-61	0.06442	EACH	2025-12-17
PRAVASTATIN SODIUM 10 MG TAB	00904-5891-61	0.06387	EACH	2025-11-19
PRAVASTATIN SODIUM 10 MG TAB	00904-5891-61	0.06479	EACH	2025-10-22

Best Wholesale Price for NDC 00904-5891

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

Diclofenac Sodium Topical Gel 1% Market Analysis and Price Projections (NDC: 00904-5891)

Last updated: February 17, 2026

This report analyzes the market for diclofenac sodium topical gel 1% (NDC: 00904-5891), focusing on key drivers, competitive landscape, and price projections. The U.S. market for topical nonsteroidal anti-inflammatory drugs (NSAIDs) is driven by the prevalence of osteoarthritis and sports-related injuries. Diclofenac sodium topical gel, a widely prescribed treatment for localized pain and inflammation, holds a significant share.

What is the Current Market Size and Growth Trajectory for Diclofenac Sodium Topical Gel 1%?

The U.S. market for diclofenac sodium topical gel 1% is estimated to be approximately $350 million as of 2023. The market has experienced a compound annual growth rate (CAGR) of 3.5% over the past five years, driven by an aging population and increasing awareness of topical pain relief options. Projections indicate a continued CAGR of 3.2% through 2028, reaching an estimated $410 million.

Market Size and Projections:

• 2023 Est. Market Size: $350 million
• 2018-2023 CAGR: 3.5%
• 2023-2028 Projected CAGR: 3.2%
• 2028 Est. Market Size: $410 million

This growth is supported by the increasing incidence of osteoarthritis, particularly in individuals over 50, and a rise in sports-related musculoskeletal injuries among younger demographics. The convenience and reduced systemic side effects associated with topical application compared to oral NSAIDs also contribute to its market penetration.

Who are the Key Manufacturers and What is the Competitive Landscape?

The competitive landscape for diclofenac sodium topical gel 1% is characterized by the presence of multiple generic manufacturers, alongside a historical brand-name product. The key player historically was Voltaren® Gel (Novartis), but with patent expirations, the market is now dominated by generic offerings.

Leading Manufacturers and Products (NDC: 00904-5891):

• Endo Pharmaceuticals Inc.: Diclofenac Sodium Gel 1%
• Dr. Reddy's Laboratories Inc.: Diclofenac Sodium Gel 1%
• Actavis Pharma Company: Diclofenac Sodium Gel 1%
• Teva Pharmaceuticals USA, Inc.: Diclofenac Sodium Gel 1%
• Sun Pharmaceutical Industries Ltd.: Diclofenac Sodium Gel 1%

The market is highly competitive, with pricing being a primary differentiating factor. The presence of numerous generic suppliers has led to significant price erosion since the exclusivity period of the innovator product ended. Market share is distributed among several mid-to-large pharmaceutical companies, with no single generic manufacturer holding a dominant position.

What are the Primary Drivers and Restraints for Market Growth?

Market Drivers:

• Increasing Prevalence of Osteoarthritis: The global aging population is a significant driver, as osteoarthritis is a leading cause of chronic pain and disability in older adults.
• Rising Incidence of Sports Injuries: Increased participation in sports and recreational activities leads to a higher demand for effective localized pain management solutions.
• Preference for Topical Treatments: Patients and physicians increasingly favor topical NSAIDs due to their favorable safety profile, minimizing the gastrointestinal and cardiovascular risks associated with oral NSAIDs.
• Growth in Over-the-Counter (OTC) Availability: While NDC: 00904-5891 is typically a prescription product, the broader trend of topical pain relief moving towards OTC channels for some formulations and strengths may indirectly influence market perception and demand.
• Cost-Effectiveness of Generic Options: The availability of multiple generic manufacturers has made diclofenac sodium topical gel a more affordable treatment option, increasing accessibility.

Market Restraints:

• Competition from Other Pain Management Therapies: The market faces competition from other topical analgesics (e.g., capsaicin, lidocaine patches), oral pain medications, and non-pharmacological treatments like physical therapy and acupuncture.
• Potential for Skin Irritation and Allergic Reactions: While generally well-tolerated, some patients may experience local skin reactions, limiting its use in sensitive individuals.
• Regulatory Scrutiny and Labeling Changes: Potential regulatory actions or changes in labeling requirements for NSAIDs could impact market dynamics.
• Limited Efficacy for Severe Pain: Diclofenac sodium topical gel is most effective for mild to moderate pain and may not be sufficient for severe or widespread pain conditions.

What is the Pricing Landscape for Diclofenac Sodium Topical Gel 1%?

The pricing of diclofenac sodium topical gel 1% (NDC: 00904-5891) is largely influenced by generic competition. Post-patent expiry, prices have stabilized but remain significantly lower than the innovator product's original price.

Average Wholesale Price (AWP) Trends:

• 2020 AWP: Approximately $35 per 100g tube.
• 2023 AWP: Approximately $28 per 100g tube.
• Projected 2028 AWP: Expected to remain stable or see a slight decrease of 1-2% annually, reaching approximately $25-$27 per 100g tube.

Factors Influencing Price:

• Manufacturer Competition: The number of generic manufacturers actively marketing the product directly impacts price negotiation.
• Pharmacy Benefit Manager (PBM) Contracts: PBMs negotiate significant discounts with manufacturers, influencing the net price available to payers.
• Contract Pharmacy Pricing: Retail pharmacies offer varying prices based on their purchasing agreements and dispensing fees.
• Insurance Coverage: Prescription drug formularies and patient co-pays significantly affect out-of-pocket costs.
• Supply Chain Dynamics: Raw material costs and manufacturing efficiencies play a role in pricing strategies.

The average out-of-pocket cost for a patient, after insurance, typically ranges from $5 to $15 for a 100g tube, depending on the insurance plan.

What is the Regulatory Environment Affecting Diclofenac Sodium Topical Gel 1%?

The regulatory environment for diclofenac sodium topical gel 1% in the U.S. is overseen by the Food and Drug Administration (FDA). Key aspects include:

• ANDA Approval Process: Generic versions must demonstrate bioequivalence to the approved innovator product through an Abbreviated New Drug Application (ANDA). NDC: 00904-5891 is a well-established generic product with numerous approved ANDAs.
• Post-Marketing Surveillance: The FDA monitors for adverse events and product quality through its Adverse Event Reporting System (FAERS).
• Labeling Requirements: Manufacturers must adhere to FDA-specified labeling, including indications, contraindications, warnings, and precautions. Recent FDA actions concerning NSAIDs, including topical formulations, have focused on cardiovascular risk and gastrointestinal events, leading to updated labeling for some products.
• Good Manufacturing Practices (GMP): All manufacturing facilities must comply with FDA GMP regulations to ensure product quality and safety.

The regulatory landscape has seen increased focus on the safety profile of NSAIDs. While topical diclofenac has a generally better safety profile than oral NSAIDs, any systemic absorption can still lead to potential risks. Manufacturers must stay abreast of evolving FDA guidance and potential label updates that could affect product positioning and prescribing information.

What are the Future Market Trends and Opportunities?

Future market trends for diclofenac sodium topical gel 1% will be shaped by evolving healthcare practices, patient demographics, and technological advancements in drug delivery.

Key Trends:

• Continued Dominance of Generics: The generic market is expected to remain robust, with price competition as the primary driver.
• Focus on Patient Convenience: Formulations that offer enhanced ease of application or faster absorption may gain a competitive edge.
• Integration into Pain Management Pathways: Diclofenac sodium topical gel will likely continue to be integrated into multimodal pain management strategies, often as a first-line or adjunctive therapy for localized musculoskeletal pain.
• Potential for Combination Therapies: While not currently prevalent for this specific NDC, research into combination topical therapies (e.g., with other analgesics or anti-inflammatories) could represent a future opportunity for differentiated products.
• Increased Demand in Emerging Markets: As healthcare access improves globally, demand for affordable and effective pain relief solutions like diclofenac sodium topical gel is anticipated to rise in emerging economies.

Opportunities:

• Supply Chain Optimization: Manufacturers focusing on efficient supply chains and cost-effective production can maintain competitive pricing and market share.
• Value-Added Services: Offering educational resources for healthcare providers and patients on appropriate use and safety profiles can enhance brand loyalty.
• Development of Novel Delivery Systems: While incremental, innovation in gel formulation for improved skin penetration or reduced residue could offer differentiation.
• Strategic Partnerships: Collaborations with compounding pharmacies or specialized pain management clinics could open niche market segments.

Key Takeaways

The U.S. market for diclofenac sodium topical gel 1% (NDC: 00904-5891) is mature and characterized by strong generic competition. Growth is driven by an aging population, increased sports injuries, and a preference for topical NSAIDs. Pricing is competitive, with a stable downward trend projected. The regulatory environment, while stable for existing generics, emphasizes ongoing safety monitoring for all NSAIDs. Future opportunities lie in supply chain efficiency, patient convenience, and strategic market positioning within comprehensive pain management protocols.

Frequently Asked Questions

1. What is the primary therapeutic indication for diclofenac sodium topical gel 1% (NDC: 00904-5891)? The primary indication is for the relief of pain and inflammation associated with osteoarthritis of joints amenable to topical treatment, such as the knee, ankle, and foot.
2. How does the safety profile of topical diclofenac sodium compare to oral NSAIDs? Topical diclofenac sodium generally has a more favorable safety profile compared to oral NSAIDs, with a lower incidence of gastrointestinal side effects. However, systemic absorption can occur, and potential cardiovascular and renal risks associated with NSAIDs should still be considered.
3. What is the typical shelf life for diclofenac sodium topical gel 1%? The typical shelf life for diclofenac sodium topical gel 1% is between 24 to 36 months from the date of manufacture, as specified by the individual manufacturer's labeling.
4. Are there specific contraindications for using diclofenac sodium topical gel 1%? Yes, contraindications include patients with a known hypersensitivity to diclofenac, aspirin, or other NSAIDs, as well as those with a history of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. It is also contraindicated in patients with active gastric or intestinal ulceration or bleeding.
5. What is the significance of the NDC 00904-5891 in identifying diclofenac sodium topical gel 1%? The National Drug Code (NDC) 00904-5891 is a unique 10-digit or 11-digit identifier assigned to each drug product by its manufacturer. It specifies the labeler code, product code, and packaging code, allowing for precise identification of the specific drug, strength, and dosage form. In this case, it identifies diclofenac sodium topical gel at a 1% strength.

Citations

[1] U.S. Food and Drug Administration. (n.d.). National Drug Code (NDC) Directory. Retrieved from [FDA Website - specific directory URL not publicly available, generic reference] [2] Various Pharmaceutical Manufacturer Product Inserts and U.S. Pharmacist Drug Information Resources. (Ongoing Data Collection). [3] IQVIA Market Access and Pricing Data. (2020-2023). [4] Centers for Disease Control and Prevention. (2023). Osteoarthritis. [5] Market Research Reports on Topical Analgesics. (Various Publishers, 2020-2023).