Register entry
Hisamitsu Pharmaceutical Co., Inc.
Data as of · How to read this entry
- Registered sites
- 2
- Active NDC listings
- 16
- Labeller names
- 2
- Live patents
- 22
- Countries
- 1
- Base
- Japan
Authorisation
Registered operations
Finished drug manufacture2
Sites
Registered establishments
2| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Hisamitsu Pharmaceutical Co., Inc. | 408, Tashirodaikammachi, Tosu, Saga 841-0017, Japan (JPN) | Finished drug manufacture | 1000266995690539713 |
| Hisamitsu Pharmaceutical Co., Inc. | 23-8, Kiyoharakogyodanchi, Utsunomiya, Tochigi 321-3231, Japan (JPN) | Finished drug manufacture | 3008742780706297983 |
Catalogue
Drug listings by form and route
1616 active NDC listings: 16 human otc drug. By marketing category: OTC MONOGRAPH DRUG 11, NDA 4, ANDA 1.
| Dosage form | NDCs |
|---|---|
| patch | 11 |
| gel | 2 |
| aerosol, spray | 1 |
| cream | 1 |
| liquid | 1 |
| Route | NDCs |
|---|---|
| topical | 16 |
| percutaneous | 13 |
| transdermal | 13 |
| Labeller name on the listing | NDCs |
|---|---|
| hisamitsu pharmaceutical co., inc. | 11 |
| hisamitsu america, inc. | 5 |
Exclusivity
Patents and exclusivities
22| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 9233184 | SALONPASmenthol; methyl salicylate | product | Aug 2027 |
| 8809615 | SALONPASmenthol; methyl salicylate | product | Jan 2030 |
| 10022445 | SECUADOasenapine | product | Jul 2033 |
| 10583121 | SECUADOasenapine | product | Jul 2033 |
| 10814002 | SECUADOasenapine | product | Jul 2033 |
| 11123305 | SECUADOasenapine | product | Jul 2033 |
| 9687474 | SECUADOasenapine | product | Jul 2033 |
| 11813364 | SECUADOasenapine | product | Sept 2033 |
Catalogue
Marketed products
16| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| SALONPAS-HOT CAPSICUM | Capsaicin | patch, topical | 46581-700OTC MONOGRAPH DRUG |
| Salonpas | Camphor, Menthol, Methyl salicylate | patch, percutaneous, topical, transdermal | 46581-110OTC MONOGRAPH DRUG |
| Salonpas | Camphor, Menthol, Methyl salicylate | patch, percutaneous, topical, transdermal | 46581-210OTC MONOGRAPH DRUG |
| Salonpas | Diclofenac Sodium | gel, topical | 55328-801ANDA |
| Salonpas Arthritis Pain | Menthol, Methyl Salicylate | patch, percutaneous, topical, transdermal | 46581-680NDA |
| Salonpas Arthritis Pain | Menthol, Methyl Salicylate | patch, percutaneous, topical, transdermal | 46581-685NDA |
| Salonpas DEEP Relieving | Camphor, Menthol, Methyl salicylate | gel, percutaneous, topical, transdermal | 55328-900OTC MONOGRAPH DRUG |
| Salonpas LIDOCAINE PLUS | Benzyl alcohol, Lidocaine hydrochloride | liquid, percutaneous, topical, transdermal | 55328-901OTC MONOGRAPH DRUG |
| Salonpas LIDOCAINE PLUS | Benzyl alcohol, Lidocaine hydrochloride | cream, percutaneous, topical, transdermal | 55328-902OTC MONOGRAPH DRUG |
| Salonpas LIDOCAINE Pain Relieving | Lidocaine | patch, percutaneous, topical, transdermal | 46581-830OTC MONOGRAPH DRUG |
| Salonpas LIDOCAINE Pain Relieving | Lidocaine | patch, percutaneous, topical, transdermal | 55328-100OTC MONOGRAPH DRUG |
| Salonpas Pain Relief | Menthol, Methyl Salicylate | patch, percutaneous, topical, transdermal | 46581-670NDA |
| Salonpas Pain Relief | Menthol, Methyl Salicylate | patch, percutaneous, topical, transdermal | 46581-675NDA |
| Salonpas Pain Relieving LIDOCAINE 4% FLEX | Lidocaine | patch, percutaneous, topical, transdermal | 46581-840OTC MONOGRAPH DRUG |
| Salonpas pain relieving JET | Menthol, Methyl salicylate | aerosol, spray, percutaneous, topical, transdermal | 46581-440OTC MONOGRAPH DRUG |
| Salonpas pain relieving hot | Capsaicin, Menthol | patch, topical | 46581-871OTC MONOGRAPH DRUG |
Neighbours
Registered in the same town
1- Chugai Pharmaceutical Co., Ltd.Utsunomiya, JPN
Compare
Comparable companies in Japan
- Sumitomo Pharma Co., Ltd.2 sites · 24 NDC
- Bushu Pharmaceuticals, Ltd.2 sites · 11 NDC
- ASO Pharmaceutical Co. Ltd.2 sites · 10 NDC
- Lead Chemical Co., Ltd.2 sites · 7 NDC
- Nipro Pharma Corporation2 sites · 2 NDC
- KATAYAMA SEIYAKUSYO CO., LTD.2 sites · 0 NDC
- Sucampo Pharma Americas, LLC2 sites · 0 NDC
- Taiho Oncology, Inc.2 sites · 0 NDC
- YMC India private limited2 sites · 0 NDC
- Sato Pharmaceutical Co., Ltd.1 site · 33 NDC
Enquiry
Common questions
- Is Hisamitsu Pharmaceutical Co., Inc. FDA approved?
- Hisamitsu Pharmaceutical Co., Inc. holds 2 FDA-registered establishments in Japan. 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 Hisamitsu Pharmaceutical Co., Inc.'s drugs manufactured?
- The FDA register lists Tosu; Utsunomiya. Registered operations: finished drug manufacture.
- What drugs does Hisamitsu Pharmaceutical Co., Inc. make?
- 16 products are listed under Hisamitsu Pharmaceutical Co., Inc. in the openFDA NDC Directory, most often as patch; gel; aerosol, spray. 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.