Last updated: June 2, 2026
Executive summary: Suppliers for Niacor (niacin) are generally structured across (1) API (niacin) producers, (2) finished-dose manufacturers for Niacor-branded products and authorized generics, and (3) wholesalers/secondary distributors that carry the drug under U.S. distribution channels. Without the specific strength, dosage form, NDC(s), and whether the user means the U.S. branded product or any authorized generic, a complete, accurate supplier list cannot be produced.
Who supplies niacor (niacin) API and finished tablets in the U.S.?
Featured snippet answer: Niacor is a niacin (nicotinic acid) product. Supply chains typically include upstream niacin (nicotinic acid) API producers and downstream finished-dose tablet manufacturers that package and label the product for sale through U.S. wholesalers.
How the niacin supply chain is usually mapped
- API level (nicotinic acid/niacin): bulk chemical manufacturers who sell niacin to formulators.
- Finished dose (tablets): companies that perform blending, compression/tableting, film coating (if applicable), and packaging.
- Distribution: branded product and generic product flows through major U.S. wholesalers (and sometimes specialty distributors depending on sourcing and inventory).
Which companies manufacture niacin tablets that compete with Niacor?
Featured snippet answer: Competitors to a branded niacin tablet product are usually generic manufacturers holding ANDA approvals for the same dosage form and strength, plus any authorized labelers distributing branded/marketed versions.
Where to identify tablet manufacturers
- FDA product labeling and NDC-to-application mapping via FDA records.
- Orange Book listings tied to the specific active ingredient, dosage form, and strength for Niacor’s exact product.
What is the Orange Book status of Niacor (niacin) and who is listed?
Featured snippet answer: Orange Book status depends on the specific Niacor listing (drug product NDA and strength). Without the exact NDC(s) or NDA/labeler name, a correct Orange Book listing and the associated patent holders and applicants cannot be reliably stated.
What Orange Book data is typically used for supplier mapping
- Listed drug product (NDA)
- Applicant/holder (labeler/manufacturer on file)
- Associated patents (for brand/generic differentiation)
- Exclusivity or expiration markers that affect sourcing and labeler transitions
What suppliers cover niacin immediate-release vs extended-release products?
Featured snippet answer: Supply differs by release profile. Niacor is typically an immediate-release niacin tablet brand; extended-release niacin products are commonly supplied by different labelers and formulation manufacturers.
Why release profile changes suppliers
- Different formulation technology (IR vs ER matrix coatings)
- Different manufacturing controls and stability requirements
- Different regulatory submissions and labeler chains
How do generic niacin tablet manufacturers source API from niacin suppliers?
Featured snippet answer: Most generic tablet makers source niacin API from chemical suppliers that manufacture nicotinic acid to controlled specifications, then formulate to the required tablet composition.
Common procurement pathways
- Contract manufacturing for formulation and packaging
- Multiple-source API qualification to manage supply continuity
- Labeler-owned quality agreements with API vendors
What wholesalers distribute Niacor niacin tablets in the U.S.?
Featured snippet answer: U.S. pharmaceutical distribution for an oral small molecule like niacin is typically handled by large national wholesalers, plus regional distributors and pharmacies that source through wholesaler networks.
Typical distribution layers
- Brand/generic manufacturer or labeler to wholesalers
- Wholesaler inventory to pharmacies, PBMs, and health systems
- Secondary redistribution for backorders or channel-specific contracts
What manufacturing/IP constraints affect sourcing of Niacor?
Featured snippet answer: For older small-molecule generics like niacin, the practical constraints are often quality system compliance, supply continuity, and manufacturing capacity, not active brand exclusivity. Patent/IP constraints depend on the specific NDA listing and any still-effective formulation or process patents, which cannot be verified without product identifiers.
Which supplier risks matter for niacin (Niacor) supply continuity?
Featured snippet answer: The main operational risks are:
- Single-source API dependence (where qualification is limited)
- Regulatory quality findings affecting batch release
- Capacity shocks in chemical upstreams
- Country-level export/import disruptions
Risk indicators used in procurement
- Batch-level recalls or warning letters (quality system)
- Manufacturing site ownership changes
- API price spikes tied to global chemical supply cycles
Key Takeaways
- Niacor is niacin (nicotinic acid), supplied through a standard pharmaceutical chain: API producers, finished-dose/tablet manufacturers, and U.S. wholesalers.
- A complete supplier list requires the exact Niacor product identifiers (typically NDC and NDA/labeler). Without those, any named “suppliers” would be incomplete or potentially wrong.
- Supplier mapping is best done via FDA Orange Book drug product listings (for labelers) and NDC-to-manufacturer records, then cross-checked against wholesaler distribution lanes.
FAQs
- How can I identify the manufacturer of a specific Niacor tablet based on NDC?
- Are niacin (niacin immediate-release) and ER niacin sourced from the same API suppliers?
- Which FDA records show the applicant/labeler for niacin tablets in the Orange Book?
- What drives niacin API shortages and how do generic tablet makers qualify alternate suppliers?
- How do wholesaler backorders for niacin typically affect pharmacy availability?
References
- U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed via FDA Orange Book database).
- U.S. Food and Drug Administration. Labeling and NDC-related product information (FDA product database records).
