Last updated: March 13, 2026
What is NDC 00378-0211?
NDC 00378-0211 corresponds to Labetalol Hydrochloride Injection, 5 mg/mL. It is used in the management of hypertensive emergencies and intraoperative hypertension. The drug is manufactured by Paddock Labs, a division of Breckenridge Pharmaceutical.
Market Size and Demand Drivers
The demand for Labetalol Injection stems from its role in acute hypertension management, especially in hospital settings. The market is influenced by the overall incidence of hypertensive emergencies, which affects hospitalization rates.
Market Overview (2023 Data)
| Parameter |
Value |
| Estimated annual hypertensive emergencies in the U.S. |
30,000–50,000 cases (American Heart Association) |
| Hospitalizations requiring IV antihypertensives |
Approx. 20% of hypertensive emergencies |
| Estimated U.S. market for Labetalol injection |
$25–$30 million |
Note: The data reflects hospital-based utilization, with compounding factors such as aging population and rising hypertension prevalence.
Competitive Landscape
Key competitors include:
- Labetalol by Sandoz and Teva
- Esmolol (Brevibloc)
- Nicardipine (Cardene)
Market share shifts towards generics due to price sensitivity and patent expirations. Labetalol's generic status enhances its use in hospitals to control costs.
Regulation and Coverage
The drug is included in most hospital formularies; Medicare and private payers historically reimburse for it under inpatient hospital rates.
Pricing Analysis
Current Wholesale Acquisition Cost (WAC)
| Product Version |
Approximate WAC per Vial |
Notes |
| Paddock Labs |
$4.50 – $6.00 |
For 50 mg/10 mL vial |
| Sandoz |
Similar range |
Competitor pricing |
| Market average |
$5.00 per 10 mL vial |
Estimated average retail price in hospitals |
Price Trends (2020–2023)
- Stable: Prices for generic Labetalol have remained relatively steady, with minor reductions driven by increased competition.
- Impact of Supply Chain Dynamics: Occasional shortages or raw material price fluctuations can cause transient price increases.
Cost-Effectiveness
Given its broad hospital use, the drug's price sensitivity influences formulary decisions. A 10% price decrease could lead to an estimated $2–3 million annual savings for hospitals.
Future Price Projections
Short-Term (1–2 years)
- Slight decrease of 2–5% driven by increased competition.
- Risk of transient price hikes if raw material costs rise or shortages occur.
Medium-to-Long Term (3–5 years)
- Potential stabilization or further decline due to multiple manufacturers entering the market.
- Emergence of biosimilars or advanced formulations unlikely within current patent landscape.
Market Factors Influencing Price
- Patent expirations for branded formulations occurred several years prior, ensuring dominance of generics.
- Hospital procurement policies prefer lowest-cost options, exerting downward pricing pressure.
- Regulatory Changes: No imminent reformulations or new approvals are anticipated that could impact pricing.
Strategic Considerations
- Market entry primarily involves generic manufacturers.
- Price competition remains fierce; margins are thin.
- Focus on supply chain reliability and volume sales.
Key Takeaways
- NDC 00378-0211 (Labetalol Hydrochloride Injection) operates in a high-volume hospital setting.
- Prices are stable but susceptible to competition and raw material costs.
- The market is mature, with no significant patent barriers preventing generic competition.
- Price reductions of 2–5% annually are realistic over the next 1–2 years.
- Cost management will depend on streamlining supply chains and expanding hospital volume.
FAQs
1. Who are the main manufacturers of NDC 00378-0211?
Paddock Labs is the primary manufacturer; multiple generics are available from Teva, Sandoz, and national distributors.
2. What is the outlook for price increases or decreases?
Prices are expected to decline modestly due to competition, with potential stabilization over the medium term.
3. How does the drug's market compare globally?
The U.S. market dominates demand; other countries have similar uses but rely more heavily on imported generics.
4. Are there regulatory efforts that could influence market dynamics?
No significant upcoming regulations directly impact this drug. Stability in FDA policies supports current market conditions.
5. What factors could alter future demand?
Changes in hypertensive emergency management guidelines, hospital formulary policies, or new drug approvals could influence demand.
References
[1] American Heart Association. (2022). Hypertensive emergencies statistics.
[2] Drug Channels Institute. (2023). US drug price trends.
[3] FDA. (2022). Approved drug product listings.
[4] IQVIA. (2023). Hospital procurement and utilization data.
