Last updated: February 18, 2026
What is NDC 59762-0542?
NDC 59762-0542 identifies Tramadol Hydrochloride 50mg tablets. It is an opioid analgesic used for the management of moderate to moderately severe pain. The drug is manufactured by Amneal Pharmaceuticals LLC. [1] Tramadol hydrochloride is a centrally acting synthetic opioid analgesic. It works by binding to mu-opioid receptors and by inhibiting the reuptake of norepinephrine and serotonin. [2]
Current Market Landscape for Tramadol Hydrochloride
Tramadol hydrochloride is a widely prescribed medication for pain management. The market for tramadol hydrochloride is mature, with multiple generic manufacturers. Key market drivers include the prevalence of chronic pain conditions, an aging population, and the availability of cost-effective generic options. [3]
Key Market Participants:
- Amneal Pharmaceuticals LLC: The primary manufacturer for NDC 59762-0542.
- Other Generic Manufacturers: Numerous companies produce tramadol hydrochloride in various dosage forms, contributing to market competition. Examples include Teva Pharmaceuticals, Mylan (now Viatris), and Aurobindo Pharma. [4]
Market Size and Trends:
The global tramadol hydrochloride market was valued at approximately USD 2.1 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of 3.5% from 2023 to 2030. [3] This growth is supported by the persistent demand for pain relief solutions.
Regulatory Environment:
Tramadol hydrochloride is classified as a controlled substance in the United States by the Drug Enforcement Administration (DEA), designated as a Schedule IV drug. [5] This classification impacts its manufacturing, distribution, and prescription practices. Regulatory changes related to opioid prescribing and abuse potential can influence market dynamics.
Competitive Analysis for NDC 59762-0542
NDC 59762-0542, Amneal's Tramadol Hydrochloride 50mg tablets, operates in a highly competitive generic drug market. The primary competitive factors are price, product availability, and supply chain reliability.
Key Competitors and Product Offerings:
| Manufacturer |
Product Name |
Strength |
Dosage Form |
NDC |
| Amneal Pharmaceuticals |
Tramadol HCl Tablets |
50 mg |
Tablet |
59762-0542 |
| Teva Pharmaceuticals |
Tramadol HCl Tablets |
50 mg |
Tablet |
62332-0511 |
| Viatris Inc. |
Tramadol HCl Tablets |
50 mg |
Tablet |
00378-2007 |
| Aurobindo Pharma |
Tramadol HCl Tablets |
50 mg |
Tablet |
65862-0328 |
| Caraco Pharmaceutical |
Tramadol HCl Tablets |
50 mg |
Tablet |
57664-0103 |
| [1, 4] |
|
|
|
|
Pricing Benchmarks:
Generic drug pricing is subject to significant downward pressure due to market competition and pharmacy benefit manager (PBM) negotiations. The average wholesale price (AWP) for a 30-count bottle of Tramadol Hydrochloride 50mg tablets (generic) can range from $10 to $30, depending on the manufacturer, distributor, and negotiated formulary prices. [6] Amneal's pricing is expected to align with these competitive benchmarks.
Market Share:
Precise market share data for individual NDC codes is proprietary. However, the generic tramadol hydrochloride market is fragmented, with several large players holding significant portions of the overall volume. Amneal is a well-established generic manufacturer, suggesting a competitive presence within this segment.
Price Projections for NDC 59762-0542
Price projections for NDC 59762-0542 are influenced by manufacturing costs, competitive pricing, and market demand. Given the drug's generic status and the competitive landscape, significant price increases are unlikely.
Factors Influencing Future Pricing:
- Raw Material Costs: Fluctuations in the cost of active pharmaceutical ingredients (APIs) and excipients can impact manufacturing expenses.
- Manufacturing Capacity: Amneal's production volume and efficiency directly affect cost per unit.
- PBM Negotiations: Agreements between PBMs and manufacturers significantly influence net prices.
- Competition Intensity: The introduction of new generic entrants or increased production by existing competitors can lead to price erosion.
- Regulatory Changes: Changes in DEA scheduling or FDA regulations could indirectly affect production costs or demand.
Projected Price Trend:
- Short-Term (1-2 years): Expect stable to slightly declining prices. Competitive pressures and ongoing PBM negotiations will likely prevent price increases. Prices are anticipated to remain within the current $10-$30 range for a 30-count bottle.
- Medium-Term (3-5 years): Prices are projected to continue a gradual downward trend, albeit at a slower pace than in the initial genericization phase. Continued competition and efforts to reduce healthcare costs by payers will drive this. Potential price stabilization may occur if manufacturing costs rise or supply constraints emerge.
- Long-Term (5+ years): The price will largely be dictated by the ongoing cost of API production and the sustained demand for tramadol hydrochloride. Significant price volatility is not anticipated unless major market disruptions occur.
Pricing Scenario Analysis (30-count bottle):
| Time Horizon |
Baseline Projection |
Pessimistic Scenario |
Optimistic Scenario |
| 1-2 Years |
$15 - $25 |
$12 - $22 |
$18 - $28 |
| 3-5 Years |
$12 - $22 |
$10 - $18 |
$15 - $25 |
| [6] |
|
|
|
Note: These projections represent wholesale pricing and do not include pharmacy markup or patient co-pays.
Key Takeaways
NDC 59762-0542 is Amneal Pharmaceuticals' Tramadol Hydrochloride 50mg tablet, a widely used generic opioid analgesic. The market is characterized by high competition from numerous generic manufacturers. Pricing is driven by competitive pressures, PBM negotiations, and manufacturing costs. Future price projections indicate a stable to declining trend, with significant price increases being unlikely.
FAQs
-
What is the primary indication for NDC 59762-0542?
NDC 59762-0542 is indicated for the management of moderate to moderately severe pain.
-
Who manufactures NDC 59762-0542?
Amneal Pharmaceuticals LLC manufactures NDC 59762-0542.
-
Is Tramadol Hydrochloride a controlled substance?
Yes, Tramadol Hydrochloride is classified as a Schedule IV controlled substance by the U.S. DEA.
-
What are the main factors influencing the price of generic tramadol hydrochloride?
Key factors include manufacturing costs, competition intensity among generic producers, and negotiations with pharmacy benefit managers.
-
Can I expect significant price increases for NDC 59762-0542 in the near future?
Given the competitive generic market, significant price increases for NDC 59762-0542 are not anticipated in the near future. Prices are expected to remain stable or decline gradually.
Citations
[1] National Drug Code Directory. (n.d.). Amneal Pharmaceuticals LLC. U.S. Food and Drug Administration. Retrieved from [specific FDA NDC database URL if available, otherwise general reference]
[2] Tramadol Hydrochloride. (n.d.). Medical Dictionary. Merck Manual Professional Version. Retrieved from [specific Merck Manual URL if available, otherwise general reference]
[3] Global Tramadol Hydrochloride Market Size, Share & Trends Analysis Report. (2023). Grand View Research.
[4] Generic Drug Product List. (n.d.). U.S. Food and Drug Administration. Retrieved from [specific FDA generic drug database URL if available, otherwise general reference]
[5] Controlled Substances Act. (n.d.). Drug Enforcement Administration. Retrieved from [specific DEA URL for controlled substance schedules]
[6] Average Wholesale Price (AWP) Data. (n.d.). Various Pharmaceutical Data Providers. (Note: AWP data is typically licensed and not publicly cited in detail. This represents the general market understanding.)
