Last updated: June 3, 2026
Who supplies FENTANYL-25 in the US market?
No complete, actionable supplier list can be produced from the provided input. “FENTANYL-25” is not an FDA-standard drug identifier, and multiple fentanyl products exist with different dosage forms, strengths, label indications, and supply chains. Without an unambiguous mapping of “FENTANYL-25” to a specific active ingredient (fentanyl), dosage form (e.g., patch vs tablet vs injection), strength, labeler (NDAs/ANDAs), and FDA application number, supplier and distributor conclusions would be unreliable.
Which companies are manufacturers and labelers for fentanyl 25 mg and equivalent strengths?
A credible manufacturer-and-labeler mapping requires the exact FDA product record (e.g., NDA/ANDA number, application labeler, dosage form, and strength). Fentanyl has multiple commercial products and dosage forms, each with different authorized manufacturers, packaging sites, and wholesalers. With only “FENTANYL-25,” no definitive set of manufacturing entities can be stated.
Dosage form matters: what does “25” correspond to?
Common “fentanyl 25” interpretations include:
- 25 mcg/h fentanyl transdermal systems (patches)
- 25 mg fentanyl equivalents (varies by formulation and route)
- internal naming used by wholesalers, systems, or institutions
These map to different FDA products and different supplier rosters, so a correct supplier list depends on identifying the exact product.
What is the FDA Orange Book status of FENTANYL-25?
Orange Book coverage also depends on the exact FDA application and product. Without a product identifier, the Orange Book listing status (NDA vs ANDA reference listed drug, exclusivities, and patent coverage) cannot be matched to “FENTANYL-25.”
What generic entry risks exist for fentanyl at “25” strength?
Generic risk assessment requires:
- the specific reference listed drug (RLD)
- approved ANDAs and their launch status
- Orange Book patent expiries and Orange Book deltas (PIV/Paragraph IV)
None of these can be tied to “FENTANYL-25” without the FDA identifier.
Which suppliers control the supply chain for fentanyl products (API, finished dosage, packaging)?
For any opioid product, procurement ecosystems typically split into:
- API manufacturers (fentanyl and related intermediates)
- finished dosage manufacturers (tablets, patches, injections, etc.)
- packagers and distributors (NDC-level packaging/labeling)
A defensible supplier map must be grounded in FDA facility and labeler data (and, for controlled substances, registration-based supply records). The input does not allow that mapping.
How does FENTANYL-25 sourcing differ from other fentanyl products (patch vs tablet vs injection)?
Sourcing varies materially by:
- manufacturing complexity and regulated excipients
- cold chain requirements (for certain parenterals)
- dose uniformity controls and patch adhesive/film supply
- different FDA application families and labelers
Without dosage form and FDA product identity, any cross-product comparison would be speculative.
What contract manufacturing and distribution players are used for fentanyl dosage forms?
Contract manufacturing and distribution depend on the specific product and NDC. Without the product record, it is not possible to produce a ranked list of:
- CMOs used by the NDA holder or marketing labeler
- authorized distributors
- secondary wholesalers supplying hospitals and retail pharmacies
Key Takeaways
- “FENTANYL-25” is not sufficient to identify the exact FDA drug product, dosage form, and strength required to generate a reliable supplier list.
- Supplier identification for fentanyl depends on FDA application and product identity, which is not provided in the input.
FAQs
- How do I identify the FDA product record for a fentanyl “25” listing?
- What data sources are used to map fentanyl suppliers by NDC labeler and facility?
- Do fentanyl patches and fentanyl tablets share the same manufacturers?
- How can contract manufacturers be identified for a specific fentanyl dosage form?
- What controls sourcing risk for opioid procurement in US healthcare supply chains?
References
(No sources cited because no specific, citable FDA product record or supplier dataset was provided in the prompt.)
