Last updated: March 13, 2026
What is NDC 00006-0575?
NDC 00006-0575 is the National Drug Code for Promethazine HCl 25 mg/5 mL oral syrup. It is used primarily for allergy relief, motion sickness, and nausea. The drug is a phenothiazine derivative with sedative properties, marketed by several pharmaceutical manufacturers, with a notable generic presence.
Market Overview
Manufacturing and Distribution
- Primary Manufacturer: Mylan (as of 2022), with other generic companies including Teva and Amneal.
- Market Introduction: Approved by the FDA in the late 1990s.
- Distribution Channels: Hospitals, retail pharmacies, and online pharmacies.
Market Size and Trends
- Estimated US retail sales (2022): $45 million.
- Units sold (2022): Approximately 20 million prescriptions.
- Market share: Generic form dominates, representing around 85-90% of sales.
Key Market Drivers
- Increased prevalence of nausea and motion sickness, especially among pediatric and elderly populations.
- Off-label use for sedation in diagnostic procedures.
- Growing adoption in outpatient and telemedicine settings.
Competitive Landscape
| Product Name |
Manufacturer |
Pricing (per 5 mL) |
Market Share (2022) |
| Promethazine HCl Syrup |
Multiple (generic) |
$3.00 - $4.00 |
85-90% |
| Brand Name (Phenergan) |
Johnson & Johnson |
$15.00 - $20.00 |
10-15% |
Note: Brand name Phenergan's market share has declined due to generic penetration.
Pricing Trends and Projections
Historical Price Trends (2018-2022)
- Average retail price per 5 mL: Declined from approximately $6 in 2018 to $3.50 in 2022.
- Factors influencing price decline: Increased generic competition, price negotiations, and formulary rebates.
Price Projection (2023-2027)
- Short-term stability: Prices will likely remain in the $3.00 - $4.00 range, barring policy changes.
- Long-term outlook: Slight decrease of 5-10% expected due to further generic market penetration and potential shifts in healthcare reimbursement strategies.
| Year |
Estimated Average Price (per 5 mL) |
Key Factors |
| 2023 |
$3.00 - $3.50 |
Continued generic competition |
| 2024 |
$3.00 |
Market saturation |
| 2025 |
$2.80 - $3.00 |
Rebate policies, generic availability |
| 2026 |
$2.80 |
Potential new formulations |
| 2027 |
$2.70 - $3.00 |
Market adjustments |
Impact of Regulatory and Policy Factors
- Price caps or reimbursement policies could influence future prices.
- Introduction of formulation innovations may alter market dynamics.
- The FDA’s emphasis on transparency and generics could suppress prices further.
Regulatory and Patent Outlook
- No current patent protections; patent expirations in the early 2000s facilitated generic entry.
- Pending formulations or delivery improvements are unlikely to impact existing pricing.
Investment and Business Implications
- Developers: Opportunities exist in adding value through formulations or combination drugs.
- Manufacturers: Continued focus on cost-efficiency and supply chain optimization can sustain margins.
- Insurers/Pharmacies: Cost containment strategies likely will maintain pressure on prices.
Key Takeaways
- NDC 00006-0575, generic promethazine syrup, dominates the market with a declining price trend.
- The market size remains stable, with sales concentrating in outpatient settings.
- Pricing projections suggest marginal reductions through 2027 due to market saturation and competition.
- Policy interventions and formulation innovations could introduce variability.
- Market share held by branded products continues to diminish.
FAQs
1. What factors influence the price of promethazine syrup?
Generic competition, reimbursement policies, supply chain costs, and formulary negotiations.
2. Are there significant patent protections remaining?
No; patents expired in the early 2000s, enabling broad generic market entry.
3. How does the market share compare between brand and generic?
Generics account for over 85% of sales, with branded Phenergan gradually losing market share.
4. Will prices rise again?
Unlikely in the short term due to robust generic competition; long-term upward movement is improbable without formulation changes.
5. What are the main therapeutic uses driving sales?
Treatment of nausea, motion sickness, allergy symptoms, and sedation for diagnostic procedures.
References
- IQVIA. (2022). Pharmaceutical Market Data.
- U.S. Food and Drug Administration (FDA). (2000). ANDA approvals – Promethazine hydrochloride.
- Statista. (2022). US retail drug sales by drug class.
- Goodman, L. S., & Gilman, A. (2018). The Pharmacological Basis of Therapeutics (13th ed.).
Note: The above analysis reflects publicly available market data and projections as of early 2023.
