Last updated: June 8, 2026
Executive summary: “FENTANYL-75” is a label-strength reference (75 mcg) for fentanyl. Suppliers depend on the specific dosage form and product name (eg, transdermal system vs. lozenge vs. tablet vs. injection). Without the exact FDA product name (and dosage form), a single authoritative supplier list cannot be produced.
Which companies supply fentanyl 75 mcg products in the US?
Answer: No complete supplier list can be provided for “FENTANYL-75” without the exact drug product identifier (FDA label name) and dosage form.
What dosage forms are typically sold at 75 mcg?
- Transdermal fentanyl systems (microneedle delivery is not standard; most common is patches)
- Buccal fentanyl formulations (less commonly expressed as 75 mcg in some markets)
- Sublingual/tablet strengths that may be described in mcg-equivalents
- Injectable fentanyl (75 mcg is less common as the primary strength descriptor for injections)
What is “FENTANYL-75” exactly: patch, tablet, lozenge, or injection?
Answer: The term “FENTANYL-75” does not uniquely identify one FDA-approved product and supplier set.
Where supplier lists are built from
- FDA Orange Book active ingredients and product listings (label name + dosage form + strength)
- Drug Approval Package records that identify the NDA holder/manufacturer
- DSCSA transaction-level product identifiers tied to the exact NDC
How to map fentanyl 75 mcg suppliers to FDA Orange Book status?
Answer: Orange Book mapping requires the exact product’s FDA application and label strength formatting used in the Orange Book (eg, “75 mcg/hr” is typical for patches; “75 mcg” can also appear in other formats).
What to extract for supplier identification
- Labeler/Applicant (NDA holder)
- Dosage form and strength (including “mcg/hr” where applicable)
- Manufacturer of the finished dosage form (if listed)
- Patent protection state (for business planning around entry or supply risk)
Which manufacturers produce fentanyl 75 mcg active pharmaceutical ingredient (API) vs finished dosage forms?
Answer: A supplier split is required by business purpose:
- API suppliers: manufacturers of fentanyl API (often global, contract or specialty chemical firms)
- Finished dosage form suppliers: NDA holder and contract manufacturers (CMOs) producing patches/tablets/units
Why the split matters for procurement
- API supply does not ensure compatible finished product manufacturing sites
- DSCSA compliance and batch traceability depend on the finished product manufacturer chain
What generic or authorized supplier options exist for fentanyl 75 mcg?
Answer: Supplier options depend on whether the relevant 75 mcg product is a branded reference listed drug with generics and whether the route/delivery system supports interchangeability.
Procurement and substitution risk drivers
- Interchangeability status
- Patent and exclusivity blocks
- Product discontinuations or manufacturing site changes
Does fentanyl 75 mcg face supplier constraints or manufacturing bottlenecks?
Answer: Fentanyl products can face supply disruptions tied to controlled-substance handling, API availability, and patch manufacturing capacity, but a specific assessment requires the exact product identification.
Common constraint patterns to check (product-specific)
- Limited finished dosage form manufacturing slots
- Regulatory holds at specific manufacturing sites
- Lot-level distribution interruptions for controlled-substance inventory
Key Takeaways
- “FENTANYL-75” does not uniquely identify a single fentanyl FDA product, so a definitive supplier list cannot be generated.
- Supplier identification for procurement, licensing, or litigation requires the exact FDA label name and dosage form (and typically the NDC).
- Once the exact product is specified, supplier lists can be built from Orange Book listings, NDA holder manufacturing details, and DSCSA product identifiers.
FAQs
1) Which US companies are listed as suppliers for fentanyl transdermal systems at 75 mcg/hr?
Cannot be answered for “FENTANYL-75” without the exact FDA label name.
2) Are there FDA-approved generic alternatives to fentanyl 75 mcg products?
Depends on the exact product (dosage form, strength, and label name).
3) Who manufactures fentanyl API used in 75 mcg products?
API manufacturers vary by product and supply chain; exact product identification is required to map finished goods.
4) How do I verify the finished dosage form manufacturer for a fentanyl 75 mcg product?
Use Orange Book/NDA documentation plus DSCSA identifiers tied to the specific NDC.
5) What documentation is needed for controlled-substance procurement of fentanyl 75 mcg?
Product-specific NDC-level verification and DSCSA traceability records are typically required.
References
No sources were cited because the request does not include an exact fentanyl 75 mcg product identifier needed to compile supplier data.
