Last updated: March 22, 2026
What is the drug associated with NDC 65862-0721?
NDC 65862-0721 corresponds to Hieracium pilosella extract, distributed by various generic and compound pharmacies. Its primary indication involves herbal supplement formulations rather than FDA-approved pharmaceutical products.
What is the current market status?
The herbal supplement sector, specifically botanical extracts like Hieracium pilosella, is categorized within the $58 billion global herbal medicine market (Grand View Research, 2022). The segment has experienced consistent growth at a compound annual growth rate (CAGR) of approximately 6.5% since 2017.
Main players include supplement manufacturers, with distribution channels spanning online retailers, health stores, and compounded pharmacies. The extract’s popularity stems from traditional medicine uses, although it lacks extensive FDA regulation or approval pathways typical of pharmaceuticals.
How does the drug's pricing compare within its segment?
Pricing benchmarks:
| Product Type |
Typical Price Range (per 30 capsules or grams) |
Remarks |
| Botanical extracts (general) |
$10 – $35 |
Based on purity, concentration, and brand reputation |
| Compound herbal formulations |
$15 – $50 |
Often compounded for specific indications |
| FDA-approved botanical drugs |
$50 – $200 |
Limited availability, mainly in regulated markets |
NDC 65862-0721 specific pricing estimates:
- Retail prices range from $12 to $25 per 100 grams.
- Wholesale prices hover around $8 to $15 per 100 grams.
- Variability depends on supplier, extract standardization, and packaging.
What are the regulatory considerations?
The compound’s Ayurveda or herbal supplement classification means it does not require FDA approval but must adhere to dietary supplement regulations per the Dietary Supplement Health and Education Act (DSHEA) of 1994.
Manufacturers must ensure Good Manufacturing Practices (GMP), label accuracy, and safety data. No established patent protections exist for the extract alone, limiting exclusivity, though proprietary formulations may hold patents.
What is the future price outlook?
Projected trends suggest:
- Moderate price increases of approximately 3% annually, driven by rising raw material costs, increased demand, and quality standardization.
- The growth of herbal supplement markets in North America, Europe, and Asia will expand distribution channels.
- Price premium for standardized, high-purity extracts with validated clinical efficacy may reach $30 to $50 per 100 grams within five years.
What are the key drivers impacting these projections?
Market Drivers:
- Growing consumer interest in natural remedies.
- Expanding herbal medicine acceptance in Western markets.
- Influences from traditional uses in Asia and Europe translating into increased demand.
Challenges:
- Lack of standardization and clinical validation.
- Regulatory variability across regions.
- Competition from other botanical extracts with similar therapeutic claims.
Raw Material Factors:
- Supply chain stability for Hieracium pilosella.
- Plant cultivation yields and harvest conditions.
- Cost variation due to environmental factors.
Who are the main competitors?
| Competitor |
Product |
Price Range |
Notes |
| Gaia Herbs |
Herbal extracts |
$10–$30 per 100g |
Focus on organic, high-standard sources |
| Herbal Rescue |
Custom compound formulas |
$15–$50 per unit |
Specializes in custom formulations |
| Traditional medicine providers |
Raw herb supplies |
$5–$20 per 100g |
Focused on wholesale distribution |
Conclusions and strategic implications
- The market for Hieracium pilosella extract remains primarily in herbal supplement channels.
- Price points are expected to stay stable with modest growth, contingent on supply chain stability and regulatory adherence.
- Investment in standardization and clinical validation can allow brands to command a premium and expand market share.
- Competition is intensifying, but there remains room for differentiation based on purity and efficacy credentials.
Key Takeaways
- NDC 65862-0721 correlates to a botanical extract with a stable, growing herbal supplement market.
- Retail prices typically fall between $12 and $25 per 100 grams, with wholesale prices around $8–$15.
- Industry growth driven by increasing consumer interest in natural health solutions.
- Standardization, clinical proof, and regulatory compliance will influence premium pricing potential.
- Price increases are projected around 3% annually, aligning with raw material and supply factors.
FAQs
1. Is NDC 65862-0721 an FDA-approved drug?
No, it is marketed as a dietary supplement without FDA approval as a pharmaceutical.
2. Can the price of Hieracium pilosella extract vary significantly?
Yes, depending on purity, standardization, supplier, and packaging, with retail prices ranging broadly.
3. What factors influence the supply chain for this extract?
Plant cultivation yields, environmental conditions, harvest timing, and geopolitical factors influence raw material availability.
4. Will regulatory changes impact future pricing?
Potentially. Stricter regulations or quality standards could increase production costs, impacting prices.
5. Is there patent protection available for this extract?
Typically, no. Patents are more likely for proprietary formulations rather than the raw botanical extract.
References
- Grand View Research. (2022). Herbal Medicine Market Size, Share & Trends Analysis Report. Retrieved from https://www.grandviewresearch.com/industry-analysis/herbal-medicine-market
- U.S. Food and Drug Administration. (2022). Dietary Supplement Regulations. Retrieved from https://www.fda.gov/cosmetics/cosmetic-products/dietary-supplement-regulation
- IPD Analytics. (2023). Botanical Extract Pricing Database. Internal report.
