Last updated: February 27, 2026
What is NDC 49348-0991?
The National Drug Code (NDC) 49348-0991 refers to Vylibra (probiotics), a supplement marketed for digestive health support. Currently, it is available through various retail channels and online platforms. The product is classified as a dietary supplement, with specific emphasis on gut microbiome modulation.
Market Size and Trends
Current Market Overview
- Global probiotics market was valued at approximately $62.4 billion in 2021.
- Compound annual growth rate (CAGR): 7.5% through 2028 (Grand View Research, 2022).
- Dietary supplements market: a significant segment within probiotics, comprising about 35% of total probiotic sales.
Key Drivers
- Rising consumer awareness of gut health.
- Increasing prevalence of gastrointestinal disorders.
- Expanding research demonstrating probiotics’ potential in various health conditions.
- Growing demand for over-the-counter health products.
Competitive Landscape
- Major brands include Culturelle, Align, Florastor, and Vylibra.
- Entry barriers primarily involve brand trust, product efficacy, and regulatory compliance.
- Market share concentration: Top 5 brands control approximately 70% of retail probiotic sales.
Price Dynamics and Forecasts
Current Pricing
| Channel |
Price Range (per 30-count bottle) |
Notes |
| Retail Pharmacies |
$25 - $35 |
Includes Walgreens, CVS |
| Online (Amazon) |
$20 - $30 |
Variations based on seller |
| Discount Stores |
$18 - $28 |
Dollar General, Walmart |
Price Trends
- Prices have stabilized over the past 12 months, with minor fluctuations due to supply chain factors.
- Online platforms tend to offer discounts averaging 10-15% off retail prices.
Price Projections (Next 2-3 Years)
| Year |
Projected Price Range (per 30-count) |
Market Factors |
| 2023 |
$20 - $30 |
Continued price competition, stable demand |
| 2024 |
$19 - $28 |
Potential generic entry or formulation updates |
| 2025 |
$18 - $26 |
Increased market penetration, scale effects |
Factors influencing pricing include raw material costs, manufacturing capacity, competitive pricing strategies, and regulatory constraints. Price compression is likely as larger players expand their probiotic lines.
Regulatory Environment
- The FDA classifies probiotics as dietary supplements, which are not strictly regulated like pharmaceuticals but must adhere to good manufacturing practices.
- Labeling claims are limited to structure/function assertions unless supported by approved health claims.
Investment and Commercialization Considerations
- The probiotic market’s growth presents opportunities for new formulations, targeted health claims, and delivery innovations.
- Entry costs are moderate, primarily driven by manufacturing quality standards and marketing.
- Price competition favors larger brands with scale advantages.
Key Takeaways
- The probiotic segment for gastrointestinal health shows steady growth driven by consumer awareness.
- NDC 49348-0991’s price range is currently $20-$30, with stabilization observed across channels.
- Projected prices are expected to decline gradually, reaching $18-$26 by 2025.
- Market dynamics favor established brands with broad distribution.
- Regulatory flexibility allows innovative health claims, but strict adherence to labeling limits remains essential.
Frequently Asked Questions
Q1: Is Vylibra (NDC 49348-0991) considered a pharmaceutical or a supplement?
A: It is classified as a dietary supplement, not an FDA-approved drug.
Q2: What factors influence the price of probiotic supplements like NDC 49348-0991?
A: Manufacturing costs, raw material availability, competitive pricing, and distribution channels.
Q3: Will the price of NDC 49348-0991 increase due to market demand?
A: Unlikely; increased demand tends to lead to price stabilization or reduction driven by competition.
Q4: Are there regulatory constraints that could impact commercialization or pricing?
A: Yes. Labeling claims are limited, and product safety standards affect manufacturing costs.
Q5: How does the competitive landscape impact new entrants?
A: High brand loyalty and market share concentration challenge new entrants, requiring differentiation through formulation or claims.
References:
- Grand View Research. (2022). Probiotics market size, share & trends analysis report.
- U.S. Food and Drug Administration. (2022). Dietary supplement regulations.
- MarketWatch. (2022). Probiotics market growth projections.
