Register entry
- Registered sites
- 4
- Active NDC listings
- 40
- Labeller names
- 4
- Live patents
- 110
- Exclusivities
- 1
- Countries
- 1
- Base
- United States
Authorisation
Registered operations
Analytical testing4Active ingredient (API) manufacture1Labelling2Finished drug manufacture3Packaging1
Sites
Registered establishments
4| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| United Therapeutics Corporation | 12140 Indian Creek Court, Beltsville, Maryland (MD) 20705, United States (USA) | Analytical testing, Finished drug manufacture | 3013584633050257374 |
| United Therapeutics Corporation | 55 TW Alexander Drive, Durham, North Carolina (NC) 27713, United States (USA) | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3003825766015718364 |
| United Therapeutics Corporation | 511 Davis Dr Ste 100, Morrisville, North Carolina (NC) 27560, United States (USA) | Analytical testing | 3038472185119484908 |
| United Therapeutics Corporation | 1040 Spring Street, Silver Spring, Maryland (MD) 20910, United States (USA) | Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture | 3003368324119301623 |
Catalogue
Drug listings by form and route
4040 active NDC listings: 35 human prescription drug, 5 human otc drug. By marketing category: NDA 34, OTC MONOGRAPH DRUG 5, BLA 1.
| Dosage form | NDCs |
|---|---|
| inhalant | 11 |
| kit | 11 |
| injection, solution | 6 |
| tablet, extended release | 5 |
| liquid | 3 |
| solution | 2 |
| injection | 1 |
| tablet | 1 |
| Route | NDCs |
|---|---|
| oral | 17 |
| intravenous | 7 |
| subcutaneous | 5 |
| topical | 5 |
| Labeller name on the listing | NDCs |
|---|---|
| united therapeutics corporation | 35 |
| united laboratories inc. | 3 |
| united industries corporation | 1 |
| united laboratories, inc. | 1 |
Exclusivity
Patents and exclusivities
110| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 10376525 | TYVASOtreprostinil | use | May 2027 |
| 11357782 | TYVASO DPItreprostinil | use | May 2027 |
| 9339507 | TYVASOtreprostinil | product | Mar 2028 |
| 9358240 | TYVASOtreprostinil | use | May 2028 |
| 8653137 | REMODULINtreprostinil | use | Sept 2028 |
| 8658694 | REMODULINtreprostinil | use | Sept 2028 |
| 11723887 | ORENITRAM, REMODULIN, TYVASO, TYVASO DPItreprostinil; treprostinil diolamine | substance | Dec 2028 |
| 9593066 | ORENITRAM, REMODULIN, TYVASO, TYVASO DPItreprostinil; treprostinil diolamine | substance | Dec 2028 |
| 7999007 | REMODULINtreprostinil | product | Mar 2029 |
| 8410169 | ORENITRAMtreprostinil diolamine | product | Feb 2030 |
| 10772883 | TYVASO DPItreprostinil | product | Jun 2030 |
| 8349892 | ORENITRAMtreprostinil diolamine | product | Jan 2031 |
| 8747897 | ORENITRAMtreprostinil diolamine | product | Aug 2031 |
| 12679811 | TYVASO DPItreprostinil | use | Mar 2034 |
| 10421729 | TYVASO DPItreprostinil | product | Apr 2035 |
| 11826327 | TYVASO, TYVASO DPItreprostinil | use | Feb 2042 |
| Product | Exclusivity | Until |
|---|---|---|
| ORENITRAMTREPROSTINIL DIOLAMINE | ODE-272 Orphan drug | Oct 2026 |
Catalogue
Marketed products
40| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| ADCIRCA | Tadalafil | tablet, oral | 66302-467NDA |
| Alcohol-Free Hand Sanitizing Foam | BENZALKONIUM CHLORIDE | solution, topical | 63998-764OTC MONOGRAPH DRUG |
| BiteMD External Analgesic First Aid Antiseptic | Benzocaine, Camphor (Synthetic), and Phenol | liquid, topical | 79364-0932OTC MONOGRAPH DRUG |
| Contact Instant Antiseptic Hand Sanitizer | Contact Instant Antiseptic Hand Sanitizer | liquid, topical | 63998-693OTC MONOGRAPH DRUG |
| Instant Antiseptic Hand Sanitizer | Alcohol | solution, topical | 63998-364OTC MONOGRAPH DRUG |
| Meringue Foaming Dye Free Antibacterial | Choroxylenol | liquid, topical | 63998-758OTC MONOGRAPH DRUG |
| Orenitram | treprostinil | tablet, extended release, oral | 66302-300NDA |
| Orenitram | treprostinil | tablet, extended release, oral | 66302-302NDA |
| Orenitram | treprostinil | tablet, extended release, oral | 66302-310NDA |
| Orenitram | treprostinil | tablet, extended release, oral | 66302-325NDA |
| Orenitram | treprostinil | tablet, extended release, oral | 66302-350NDA |
| Orenitram | treprostinil | kit | 66302-361NDA |
| Orenitram | treprostinil | kit | 66302-362NDA |
| Orenitram | treprostinil | kit | 66302-363NDA |
| Remodulin | treprostinil | injection, solution, intravenous, subcutaneous | 66302-101NDA |
| Remodulin | treprostinil | injection, solution, intravenous, subcutaneous | 66302-102NDA |
| Remodulin | treprostinil | injection, solution, intravenous, subcutaneous | 66302-105NDA |
| Remodulin | treprostinil | injection, solution, intravenous, subcutaneous | 66302-110NDA |
| Remodulin | treprostinil | injection, solution, intravenous, subcutaneous | 66302-114NDA |
| Sterile Diluent for Remodulin | water | injection, solution, intravenous | 66302-150NDA |
| TYVASO | treprostinil | inhalant, oral | 66302-206NDA |
| Tyvaso DPI | treprostinil | kit | 66302-610NDA |
| Tyvaso DPI | treprostinil | inhalant, oral | 66302-616NDA |
| Tyvaso DPI | treprostinil | kit | 66302-620NDA |
| Tyvaso DPI | treprostinil | kit | 66302-630NDA |
| Tyvaso DPI | treprostinil | inhalant, oral | 66302-632NDA |
| Tyvaso DPI | treprostinil | kit | 66302-640NDA |
| Tyvaso DPI | treprostinil | inhalant, oral | 66302-648NDA |
| Tyvaso DPI | treprostinil | kit | 66302-650NDA |
| Tyvaso DPI | treprostinil | kit | 66302-660NDA |
| Tyvaso DPI | treprostinil | inhalant, oral | 66302-664NDA |
| Tyvaso DPI | treprostinil | kit | 66302-670NDA |
| Tyvaso DPI | treprostinil | inhalant, oral | 66302-680NDA |
| Tyvaso DPI | treprostinil | inhalant, oral | 66302-716NDA |
| Tyvaso DPI | treprostinil | kit | 66302-720NDA |
| Tyvaso DPI | treprostinil | inhalant, oral | 66302-732NDA |
| Tyvaso DPI | treprostinil | inhalant, oral | 66302-748NDA |
| Tyvaso DPI | treprostinil | inhalant, oral | 66302-764NDA |
| Tyvaso DPI | treprostinil | inhalant, oral | 66302-780NDA |
| Unituxin | DINUTUXIMAB | injection, intravenous | 66302-014BLA |
Neighbours
Registered in the same town
12- Almac Clinical Services, LLCDurham, NC · 3 sites
- BioAgilytix Labs, LLCDurham, NC; Morrisville, NC · 3 sites
- Merck & Co., Inc.Durham, NC · 2 sites
- KBI Biopharma, Inc.Durham, NC · 2 sites
- Biogen International GmbHMorrisville, NC · 2 sites
- PETNET Solutions, Inc.DURHAM, NC
- Cardinal Health 418, Inc.Beltsville, MD
- Catalent Pharma Solutions Inc.Morrisville, NC
- Novo Nordisk Inc.Durham, NC
- Alcami Carolinas CorporationMorrisville, NC
- Eli Lilly and CompanyDurham, NC
- Exel Inc. dba DHL Supply Chain (USA)Morrisville, NC
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Enquiry
Common questions
- Is United Therapeutics Corporation FDA approved?
- United Therapeutics Corporation holds 4 FDA-registered establishments in the United States. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
- Where are United Therapeutics Corporation's drugs manufactured?
- The FDA register lists Beltsville, MD; Durham, NC; Morrisville, NC; Silver Spring, MD. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.
- What drugs does United Therapeutics Corporation make?
- 40 products are listed under United Therapeutics Corporation in the openFDA NDC Directory, most often as inhalant; kit; injection, solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.
Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.