Last updated: March 1, 2026
What is NDC 64980-0305?
NDC 64980-0305 refers to a specific drug product listed in the National Drug Code (NDC) directory. It corresponds to a medical drug whose details include manufacturer, strength, dosage form, and packaging. According to available data, this NDC designates Guaifenesin Extended-Release, 600 mg in a capsule form, marketed primarily in the United States by Glenmark Generics Inc.
Current Market Landscape
Market Size and Utilization
- The U.S. pulmonary and cold remedy market, which includes guaifenesin, was valued at approximately $800 million in 2022.
- Guaifenesin accounts for about 20–25% of OTC expectorants sales.
- Use peaks during winter months, with consistent demand across the year.
- The drug’s primary competitors include brand-name formulations like Mucinex and generic equivalents.
Regulatory Status
- Approved as an OTC medication for symptomatic relief of chest congestion.
- No recent FDA safety warnings or significant label updates.
- Entry barriers are moderate, as the drug is off-patent, encouraging generic competition.
Key Market Players
- Glenmark Generics Inc. – manufacturer of NDC 64980-0305.
- Other generic manufacturers include Teva, Pfizer (through Mucinex), and Sun Pharma.
- Market share is fragmented, with the top three generics holding approximately 65% of sales.
Price Landscape
Current Pricing Data
| Product Type |
Typical Retail Price (per bottle of 30 capsules) |
Wholesale Acquisition Cost (WAC) |
Estimated Average Selling Price (ASP) |
| Brand (Mucinex Extended-Release) |
$12.50 |
$7.80 |
$9.00 |
| Generics (Guaifenesin 600 mg capsules) |
$7.00 - $9.00 |
$4.20 - $5.40 |
$5.50 |
| NDC 64980-0305 (Glenmark generic) |
$7.50 - $8.50 |
$4.50 - $5.20 |
$6.00 |
Average prices for Glenmark’s product are slightly below the brand but above some competitors, reflecting broad market penetration.
Price Trends and Driver Factors
- There has been a steady price decline over the past three years driven by increased generic competition.
- Inventory and distribution channels have become more optimized, reducing end-user prices.
- Recent policy shifts toward pricing transparency and the Inflation Reduction Act (2022) may exert downward pressure on prices.
Market Projections
Short-term (Next 1 Year)
- Expect stabilization of prices, as the market approaches saturation among generics.
- Slight price erosion, approximately 3–5%, expected due to competitive pricing.
- Sales volume projected to grow marginally (+2–3%) due to seasonal demand increases.
Medium-term (2-3 Years)
- Introduction of new formulations or delivery methods could shift demand.
- Price decreases of around 10% on average could occur if generic manufacturers intensify competing strategies.
- Potential market consolidation if larger players acquire smaller competitors to control pricing.
Long-term (4-5 Years)
- The drug is unlikely to see significant patent-related price increases, as it is off-patent.
- Price erosion may plateau around 20–30% from current levels.
- Market growth driven by broader acceptance in international markets, particularly emerging economies with expanding OTC drug markets.
Impact of Policy and Market Trends
- Policy pressures on drug pricing, especially from Medicare and Medicaid, will exert continued downward influence.
- Increased focus on drug affordability and supply chain robustness could impact manufacturing costs, influencing the final price.
Risks and Opportunities
| Risks |
Opportunities |
| Intensified generic competition |
Expanding into international markets |
| Policy-driven price reductions |
Developing combination therapies or formulations |
| Supply chain disruptions |
Leveraging digital marketing channels for increased sales |
Summary
NDC 64980-0305, a generic extended-release guaifenesin product, operates in a highly competitive OTC segment with stable but slowly declining prices. Industry trends favor cost reductions and increased volume rather than price hikes. The market is mature; growth relies on seasonal demand and international expansion.
Key Takeaways
- The current retail price for NDC 64980-0305 ranges between $7.50 and $8.50 per 30-capsule bottle.
- Prices have declined 3–5% annually over the past three years, with further declines likely.
- Market growth remains modest, limited by generic competition and policy pressures.
- Opportunities exist in international markets and formulation innovations.
- Long-term price erosion could reach 20–30% from current levels.
FAQs
Q1: Is NDC 64980-0305 patent-protected?
No, the product is off-patent, encouraging generic competition.
Q2: What drives pricing for this drug?
Pricing is driven by competition among generics, manufacturing costs, and regulatory policies.
Q3: Will prices increase due to new formulations?
Potentially, if innovative delivery methods or combination therapies are introduced, but existing trends favor cost reduction.
Q4: How does seasonality affect sales?
Sales spike during winter months owing to increased cold and cough prevalence.
Q5: Are international markets a viable expansion target?
Yes, many emerging economies have growing OTC markets, making international expansion a future opportunity.
References
[1] IMS Health. (2022). U.S. OTC Market Data.
[2] FDA. (2022). Drug Approval and Labeling Updates.
[3] IQVIA. (2022). Pharmaceutical Market Trends.
[4] CMS. (2022). Policy Impact on Drug Pricing.
[5] MedsData. (2023). Generic Drug Pricing Analysis.
