Last updated: June 1, 2026
Nuedexta (dextromethorphan HBr/quinidine sulfate) is sourced through a defined US supply chain built around approved-manufacturing and commercial supply roles. The suppliers that matter for licensing, procurement, and launch risk are (1) the drug-product and API manufacturing sites and (2) the labeled-marketer/distributor entities tied to NDC supply.
Who are the key suppliers for Nuedexta (dextromethorphan HBr/quinidine sulfate) in the US?
Short answer: Nuedexta’s commercial supply is tied to (a) the approved manufacturer(s) of the finished drug product for each NDC and (b) the approved API suppliers for dextromethorphan and quinidine reflected in FDA filings and Orange Book manufacturing data. The labeled US marketer/distributor is the controlling interface for ordering and contract supply.
What supplier roles exist in the Nuedexta supply chain?
- Drug-product (finished dosage form) manufacturing
- Site(s) producing the final tablets (strength: dextromethorphan 20 mg/quinidine 10 mg per tablet, twice daily regimen).
- API manufacturing
- Separate sites for dextromethorphan HBr and quinidine sulfate used in the drug product.
- Marketer and distributor
- Entity listed as the product’s holder for commercial labeling and ordering channels.
Which companies supply Nuedexta’s commercial product?
No supplier-identifying dataset was provided in the prompt, and the analysis requires Orange Book/NDC label manufacturing pull-through to be complete and accurate. Without that, naming specific supplier companies would risk misidentification of NDC-level manufacturing responsibility.
What does FDA Orange Book list for Nuedexta suppliers (drug product and manufacturing sites)?
Short answer: The FDA Orange Book lists each approved application’s listed drug and the associated manufacturing sites and product attributes. For supplier mapping, the actionable fields are:
- application number (NDA)
- listed strength(s)
- dosage form
- patent/exclusivity (not supplier identity itself, but helps tie to application changes)
- manufacturer/labeler and associated manufacturing site(s)
How to interpret Orange Book supplier data for Nuedexta
- Orange Book “Applicant/Holder” indicates the regulatory sponsor responsible for the NDA.
- Orange Book manufacturing site fields indicate where the drug product is made for that NDC.
- Switches in NDC manufacturer can occur through site changes, tech transfers, or labeling revisions; supplier mapping must be NDC-specific.
Which Nuedexta NDC(s) matter for supplier identification?
Supplier identity can differ by:
- NDC (10-digit labeler code + product code)
- packaging configuration (bottles vs cartons)
- strength configuration (though Nuedexta’s strength is narrow)
- changes in manufacturing site assignments over time
How many Nuedexta drug-product manufacturing sites exist and can suppliers change by NDC?
Short answer: The number of manufacturing sites is determined at the NDC level in FDA’s listing history and can change when the NDA is amended for manufacturing changes.
What usually triggers supplier changes for branded CNS drugs like Nuedexta
- Post-approval manufacturing changes filed under CMC supplements
- Contract manufacturing reassignments
- Sterile vs non-sterile is not the issue here (Nuedexta is oral solid), but packaging, compression/film-coating lines, and analytical release site changes can still shift responsibilities.
Which suppliers make the APIs used in Nuedexta (dextromethorphan and quinidine)?
Short answer: API suppliers are reflected in CMC sections of the NDA and may also be indirectly visible via manufacturing site listings for drug substance and drug product. Accurate naming requires direct linkage to the NDA’s listed manufacturing sites and/or DMFs referenced in the regulatory record.
Why API supplier identification is harder than drug-product supplier identification
- Many API DMFs can be referenced without being publicly enumerated as “suppliers” in a simple label view.
- Multiple API suppliers can feed the same tablet-manufacturing site under the same quality system.
What supplier constraints matter for Nuedexta manufacturing and supply continuity?
Short answer: The limiting factors for contract supply typically include release testing capacity, tablet line availability, and API supply continuity for the quinidine and dextromethorphan inputs.
Nuedexta supply chain bottlenecks that affect lead times
- API availability and quality release
- API lot qualification and stability testing schedules.
- Tablet manufacturing slotting
- Compression, blending, and any coating/finishing steps.
- Analytical release workload
- Batch release and stability pulls before distribution.
Which companies act as the labeled marketer/distributor for Nuedexta?
Short answer: The marketer/distributor is the primary counterparty for ordering and wholesale distribution in the US. That entity is specified on the FDA label and generally matches the NDA holder listed in the Orange Book.
How to map marketer to ordering channels
- The labeler drives wholesaler catalog visibility.
- The NDC drives which specific manufacturing site’s product is being ordered.
- Contracts often bind at the NDC-to-manufacturer level when supply substitutions are involved.
What generic or biosimilar competition implies for Nuedexta suppliers?
Nuedexta is a small-molecule combination product (dextromethorphan/quinidine). Competitive entry impacts supply chains by:
- shifting demand to alternative manufacturers for the “same” NDC strength (if different labelers are used)
- increasing pricing pressure and margin scrutiny on CMO partners
- increasing the chance of manufacturing site expansions or reassignments by the branded supplier
How supplier risk changes when multiple competitors come online
- Contract manufacturing may be reallocated toward higher-margin products.
- API procurement contracts can be renegotiated to secure volume and shelf-life.
Key takeaways
- Supplier identification for Nuedexta is inherently NDC-specific and requires FDA listing linkage to accurately name the drug-product manufacturing sites and the labeled marketer/distributor.
- API supplier naming requires regulatory-record linkage to drug substance manufacturing/DMF references; it is less reliably deducible from label-level data.
- Manufacturing-site changes can occur post-approval; a supplier map must be maintained per NDC and per time window.
FAQs
- How do I identify the correct Nuedexta supplier for a specific pharmacy NDC?
- Do Nuedexta drug-product manufacturing sites change over time, and how can I track the changes?
- Are dextromethorphan and quinidine APIs supplied by the same vendor under Nuedexta?
- What role does the Orange Book labeler play versus the actual tablet manufacturing site?
- How does Nuedexta supply continuity depend on API supplier qualification and tablet batch release testing?
References
- FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
- FDA. Drugs@FDA: Nuedexta (dextromethorphan HBr/quinidine sulfate). U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
