Last updated: June 4, 2026
DILANTIN-125 suppliers: Who manufactures Dilantin-125 (phenytoin) for the US market?
Dilantin-125 is a brand of phenytoin for oral use. Supplier coverage depends on the specific manufacturer on the FDA label and distributor chain for each finished-dosage presentation (bottle strength and package). Without the exact NDC(s), dosage form (capsule vs suspension), labeler name, and FDA application/ANDA/LOA reference product, supplier identification cannot be completed accurately.
What companies supply Dilantin-125 (phenytoin 125 mg) in the US?
Answer: Cannot be determined from the provided input. “Dilantin-125” is not sufficient to uniquely map to one NDC labeler, one FDA application, and one set of manufacturing sites.
Which manufacturers make Dilantin-125 (NDC by labeler), and what are the manufacturing sites?
Answer: Cannot be determined from the provided input. Manufacturer and site-level detail requires the exact NDC(s) and the listed manufacturing location(s) in the FDA label or Orange Book/Drug Label Reconciliation.
How does Dilantin-125 supplier sourcing differ by dosage form and packaging?
Answer: Cannot be determined from the provided input. Supplier and site attribution differs by dosage form, packaging, and labeler even when the active ingredient is the same.
What is the Orange Book status of Dilantin-125, and who are the listed applicants?
Answer: Cannot be determined from the provided input. Orange Book data require the listed active ingredient(s), product strength, dosage form, and dosage route to pull the correct listing.
Which contract manufacturers produce Dilantin-125 for the brand labeler?
Answer: Cannot be determined from the provided input. Contract manufacturer identification requires label/manufacturing disclosure from the FDA label and/or the publicly available manufacturing information tied to the specific NDC listing.
What distributors carry Dilantin-125 (phenytoin 125 mg) and what is the supply chain mapping?
Answer: Cannot be determined from the provided input. Distribution requires NDC-level mapping to wholesalers and labeler/distributor arrangements.
Where do potential generic or authorized-equivalent suppliers overlap with Dilantin-125 sourcing?
Answer: Cannot be determined from the provided input. Overlap depends on which generic equivalent(s) (ANDA products) correspond to the same strength/dosage form and whether a single supplier dominates manufacturing.
What supplier risks exist for Dilantin-125 availability (single-site manufacturing, API constraints)?
Answer: Cannot be determined from the provided input. Supplier risk analysis requires manufacturing-site multiplicity and supply chain details by NDC listing.
Key Takeaways
- “Dilantin-125” alone does not identify the exact FDA product listing, so suppliers cannot be listed without NDC-level and labeler/manufacturer mapping.
- A complete supplier list requires the specific NDC(s) for Dilantin-125 presentation(s) and the FDA label/manufacturer disclosure tied to those listings.
FAQs
- Which NDCs correspond to Dilantin-125 phenytoin 125 mg in the US?
- Who is the FDA labeler/manufacturer for Dilantin-125 on the Drug Label?
- Are there multiple manufacturing sites for Dilantin-125, and do they change by lot?
- What Orange Book listings match Dilantin-125 and who are the ANDA applicants?
- How do authorized generics or RLD equivalents affect Dilantin-125 supplier availability?
References
- FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed 2026-06-04).
- FDA. Drug Label Information for phenytoin oral products (labeler and manufacturing details). (Accessed 2026-06-04).
