Drug
Who makes fentanyl citrate?
5 companies list fentanyl citrate as a human prescription drug. Forms: injection; injection, solution. Routes: intramuscular, intravenous.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing fentanyl citrate
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Hikma Pharmaceuticals USA Inc.United States | injection | NDANDA019101 | 9 | 4 |
| Fresenius Kabi USA, LLCUnited States | injection, solution | ANDAANDA210762, ANDA212086 | 3 | 6 |
| Civica, Inc. dba CivicaRxUnited States | injection | NDANDA019101 | 3 | 1 |
| Hospira, Inc.United States | injection, solution | NDANDA019115 | 2 | 7 |
| Phlow Corp.United States | injection | NDANDA019101 | 1 | 1 |
Bulk ingredient listings
- SpecGx LLCUnited States · 4 NDC
- Cambrex Charles City, Inc. · 3 NDC
- Chattem Chemicals, Inc.United States · 1 NDC
- LETCO MEDICAL, LLCUnited States · 1 NDC
- MEDISCA Inc.United States · 1 NDC
- Pharma Source Direct, LLCUnited States · 1 NDC
- Professional Compounding Centers of America dba PCCAUnited States · 1 NDC
- Siegfried Grafton, Inc. · 1 NDC
- Spectrum Chemical and Laboratory Products · 1 NDC
- Veranova, L.P.United States · 1 NDC
Orange Book patents
4 unexpired patents list fentanyl citrate as the active ingredient, expiring between Jul 2027 and Jan 2032. Application holders: ADALVO LTD, BTCP PHARMA LLC, CEPHALON LLC.
Enquiry
Common questions
- Who makes fentanyl citrate?
- 5 companies list fentanyl citrate as a human prescription drug in the openFDA NDC Directory, led by Hikma Pharmaceuticals USA Inc., Fresenius Kabi USA, LLC, Civica, Inc. dba CivicaRx, Hospira, Inc., Phlow Corp.. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic fentanyl citrate?
- 1 company lists fentanyl citrate under an abbreviated new drug application (ANDA), the application type used for generics, and 4 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies fentanyl citrate active ingredient?
- 10 companies list fentanyl citrate as a bulk ingredient, including SpecGx LLC, Cambrex Charles City, Inc., Chattem Chemicals, Inc., LETCO MEDICAL, LLC.