Last updated: May 26, 2026
PHENYTEK suppliers: Who manufactures and supplies phenytoin capsules and bulk drug in the US?
PHENYTEK is the brand for phenytoin, supplied in the US as capsules (extended delivery). Supplier coverage depends on whether you mean (1) FDA-labeled drug product manufacturers (capsule/packager) or (2) API/bulk phenytoin suppliers used upstream by drug makers.
At present, complete, accurate supplier identification requires PHENYTEK’s specific FDA label/manufacturer line, NDC strength/labeler, and the Orange Book listing for the exact dosage form. Without those identifiers, any supplier list risks being wrong.
Who are the labeled manufacturers and distributors for PHENYTEK capsules?
Featured snippet: PHENYTEK’s “labeler” and manufacturing/distribution responsibilities are listed by NDC/labeler on the FDA label and commercial product listings, and by the Orange Book record for the specific dosage form and strength.
What determines the “supplier” for PHENYTEK?
- NDC labeler (drug product supplier): the entity associated with the marketed product for that specific NDC.
- Dosage form manufacturer: the site listed on the FDA label as responsible for manufacture.
- Packager/distributor: entities that handle packaging and distribution for the marketed NDC.
Which companies supply phenytoin API (bulk) used to make PHENYTEK?
Featured snippet: Bulk phenytoin suppliers are identified through API registrations (DEA/TSCA listing), DMF-holder supply chains, and drug product manufacturer sourcing. A reliable API supplier list must be tied to the specific DMF(s) referenced by the PHENYTEK NDA.
API sourcing channels
- DMF-referenced manufacturers used by the PHENYTEK NDA holder or contract manufacturers.
- Third-party bulk phenytoin producers supplying multiple finished-dose brands.
What does the PHENYTEK Orange Book record show about manufacturing and patent ownership?
Featured snippet: The Orange Book listing provides NDA number(s), dosage form, and associated applicant/holder. It does not always directly enumerate API suppliers, but it links to the finished product legal entity whose manufacturing chain can then be mapped.
How to map PHENYTEK supplier to Orange Book
- Pull the Orange Book entry for “phenytoin” / “PHENYTEK” capsule (extended delivery).
- Use the applicant/holder as the starting point for labeled product manufacturing.
- Cross-reference the NDC to label text to capture the drug product manufacturer and packager.
What generic entry risks affect PHENYTEK supply continuity?
Featured snippet: PHENYTEK supply depends on ongoing compliance and manufacturing capacity across labeled sites. Generic competition and patent status can shift which contract manufacturers are used, but this requires the exact NDC and NDA linkage.
Paragraph IV and litigation impacts
- Drug supply can change if the NDA holder exits a manufacturing site or if new partners get packaged/filled roles as generics pressure market share.
How do contract manufacturing and labeler changes show up for PHENYTEK?
Featured snippet: In practice, “suppliers” change via:
- new contract manufacturing sites,
- labeler changes (packager/distributor),
- NDC-level changes (strength or packaging),
- updates in FDA label manufacturing sections.
Key Takeaways
- PHENYTEK is phenytoin capsules (extended delivery), but “suppliers” split into finished-dose labeled manufacturers/distributors and upstream phenytoin API producers.
- A defensible supplier list requires the exact PHENYTEK NDC/label strength and the Orange Book NDA record for that dosage form to identify the labeler/manufacturer.
- Upstream API supplier identification must be tied to DMF-referenced manufacturers used by the PHENYTEK NDA or its contract manufacturing chain.
FAQs
- How can I identify PHENYTEK’s labeled manufacturer from the NDC?
- Do PHENYTEK capsule manufacturers differ by strength or packaging configuration (NDC)?
- Where do I find phenytoin API suppliers used for US finished-dose brands?
- Does Orange Book list PHENYTEK’s contract manufacturing sites?
- How do generic phenytoin ER launches affect PHENYTEK supply and sourcing?
References
- FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
- FDA National Drug Code Directory (NDC). U.S. Food and Drug Administration. https://www.fda.gov/drugs/drug-approvals-and-databases/national-drug-code-directory
