Last updated: March 13, 2026
What is the Drug Identified by NDC 00054-0283?
NDC 00054-0283 corresponds to Ephedrine Sulfate Injection. It is used primarily for the treatment of hypotension and to stimulate the heart in cases of cardiac arrest. It is a vasopressor and bronchodilator, available as a sterile injectable.
Market Overview
Current Market Size
The global injectable vasopressor market, including drugs like ephedrine hydrochloride and sulfate, was valued at approximately USD 600 million in 2022. Expected compound annual growth rate (CAGR) stands at 4.1% through 2030, driven by increasing demand for emergency and anesthesia medications.
Key Market Drivers
- Rising incidence of shock, cardiac arrest, and anesthesia procedures.
- Expanding use in developing markets due to increased healthcare infrastructure.
- Use as a research chemical in pharmaceutical and clinical research settings.
Competition
Market players include:
| Company |
Product Name |
Market Share (Estimated) |
Notes |
| Pfizer |
Ephedrine Sulfate |
35% |
Established supplier with broad distribution channels |
| Sagent Pharmaceuticals |
Ephedrine Sulfate Injection |
20% |
Focused on sterile injectables |
| Other generic manufacturers |
Various generics |
30-40% |
Numerous smaller manufacturers offering competitive pricing |
Emerging generic manufacturers are increasing their market presence, exerting downward pressure on prices.
Regulatory Environment
- US FDA approval is required for both manufacturing and marketing.
- Orphan drug designation is not applicable.
- Post-approval updates focus on manufacturing process enhancements.
Pricing Analysis
Current Pricing
Wholesale acquisition cost (WAC) in the US varies:
| Label |
Price (USD per 10 mL unit) |
Notes |
| Standard |
$15 – $25 |
Price varies depending on manufacturer and order volume |
| Bulk purchasing |
$10 – $15 |
Discounted prices available for large hospital or pharmacy orders |
Factors Influencing Price
- Manufacturer production costs, which have decreased due to process improvements.
- Supply chain disruptions, leading to occasional shortages.
- Regulatory compliance costs, impacting small manufacturers most.
Price Projections (Next 3-5 Years)
| Year |
Price Range (USD per 10 mL unit) |
Influencing Factors |
| 2023 |
$13 – $25 |
Market stability; supply chain normalization post-pandemic |
| 2024 |
$12 – $23 |
Continued competition; manufacturing efficiencies observed |
| 2025 |
$10 – $20 |
Entry of additional generics; price erosion continues |
| 2026 |
$9 – $18 |
Increased generic penetration; procurement strategies impact |
Potential Impacts on Price
- Supply disruptions due to raw material shortages could temporarily spike prices.
- Regulatory changes or new safety data may increase manufacturing costs.
- New entrants to the market tend to lower prices through competition.
Future Market Trends
- Growing demand for emergency medicines will sustain sales.
- Increased use in clinical trials as a research chemical may support niche market growth.
- Price competition among generics is expected to persist, leading to further price declines.
Key Takeaways
- NDC 00054-0283 (ephedrine sulfate injection) faces a competitive environment with multiple generics.
- Market size is driven by emergency care, anesthesia, and research applications.
- Prices currently range from $10 to $25 per 10 mL unit, with projections trending downward due to generic competition.
- Supply chain and regulatory factors will influence short-term price volatility.
- Long-term price declines are anticipated, aligned with market entry of additional generic manufacturers.
FAQs
1. How is the demand for ephedrine sulfate injection expected to change?
Demand is projected to grow moderately, driven by emergency medical needs and applications in anesthesia.
2. What influences the pricing of ephedrine sulfate injection?
Pricing is affected by manufacturing costs, supply chain stability, competition among generics, and regulatory compliance expenses.
3. Are there market opportunities outside the US?
Yes, in developing countries with expanding healthcare infrastructure and limited access to branded drugs.
4. How do regulatory changes impact the market?
New safety or manufacturing standards can increase costs, potentially reducing supply or raising prices temporarily.
5. What is the outlook for new entrants in this market?
Entry barriers are moderate; regulatory approval and manufacturing scale are key, with continued price pressure expected from generics.
Sources:
- MarketsandMarkets. (2022). Vasopressor Market by Product, Application, and Region.
- FDA. (2023). Drug Approvals and Labeling.
- IQVIA. (2022). Global Pharmaceuticals Market Data.
- DrugBank. (2023). Ephedrine Sulfate.
- US Department of Health and Human Services. (2022). Healthcare Supply Chain Reports.
