Register entry
- Registered sites
- 2
- Active NDC listings
- 34
- Labeller names
- 2
- Live patents
- 0
- Countries
- 2
- Base
- United States
Authorisation
Registered operations
Active ingredient (API) manufacture1Labelling1
Sites
Registered establishments
2| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| HEC PHARM CO., LTD. The Second SiteRegistrant: HEC PHARM CO.,LTD | No. 3 Industrial Park of HEC, Yidu City, Yichang, Hubei Province 443300, China (CHN) | Active ingredient (API) manufacture | 3006259537554546110 |
| HEC Pharm USA Inc. | 101 Morgan Ln, Plainsboro, New Jersey (NJ) 08536, United States (USA) | Labelling | 3016779715962953530 |
Catalogue
Drug listings by form and route
3434 active NDC listings: 29 human prescription drug, 5 bulk ingredient. By marketing category: ANDA 29, BULK INGREDIENT 5.
| Dosage form | NDCs |
|---|---|
| tablet, film coated | 16 |
| tablet | 8 |
| powder | 5 |
| tablet, orally disintegrating | 4 |
| suspension | 1 |
| Route | NDCs |
|---|---|
| oral | 29 |
| Labeller name on the listing | NDCs |
|---|---|
| hec pharm usa inc. | 29 |
| hec pharm co., ltd | 5 |
Catalogue
Marketed products
34| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| - | Azithromycin Dihydrate | powder | 43781-0305BULK INGREDIENT |
| - | Clarithromycin | powder | 43781-0403BULK INGREDIENT |
| - | Erythromycin | powder | 43781-2103BULK INGREDIENT |
| - | Erythromycin Thiocyanate | powder | 43781-2202BULK INGREDIENT |
| FEBUXOSTAT | febuxostat | tablet, oral | 72303-0855ANDA |
| FEBUXOSTAT | febuxostat | tablet, oral | 72303-0856ANDA |
| - | Lincomycin Hydrochloride | powder | 43781-2301BULK INGREDIENT |
| OLANZAPINE | Olanzapine | tablet, oral | 72303-0835ANDA |
| OLANZAPINE | Olanzapine | tablet, oral | 72303-0836ANDA |
| OLANZAPINE | Olanzapine | tablet, oral | 72303-0837ANDA |
| OLANZAPINE | Olanzapine | tablet, oral | 72303-0838ANDA |
| OLANZAPINE | Olanzapine | tablet, oral | 72303-0839ANDA |
| OLANZAPINE | Olanzapine | tablet, oral | 72303-0840ANDA |
| OLMESARTAN MEDOXOMIL | Olmesartan medoxomil | tablet, film coated, oral | 72303-0848ANDA |
| OLMESARTAN MEDOXOMIL | Olmesartan medoxomil | tablet, film coated, oral | 72303-0849ANDA |
| OLMESARTAN MEDOXOMIL | Olmesartan medoxomil | tablet, film coated, oral | 72303-0850ANDA |
| Olanzapine | Olanzapine | tablet, orally disintegrating, oral | 72303-0841ANDA |
| Olanzapine | Olanzapine | tablet, orally disintegrating, oral | 72303-0842ANDA |
| Olanzapine | Olanzapine | tablet, orally disintegrating, oral | 72303-0843ANDA |
| Olanzapine | Olanzapine | tablet, orally disintegrating, oral | 72303-0844ANDA |
| Oseltamivir Phosphate | oseltamivir phosphate | suspension, oral | 72303-0851ANDA |
| Rosuvastatin calcium | Rosuvastatin calcium | tablet, film coated, oral | 72303-0827ANDA |
| Rosuvastatin calcium | Rosuvastatin calcium | tablet, film coated, oral | 72303-0828ANDA |
| Rosuvastatin calcium | Rosuvastatin calcium | tablet, film coated, oral | 72303-0829ANDA |
| Rosuvastatin calcium | Rosuvastatin calcium | tablet, film coated, oral | 72303-0830ANDA |
| Sildenafil | Sildenafil | tablet, film coated, oral | 72303-0845ANDA |
| Sildenafil | Sildenafil | tablet, film coated, oral | 72303-0846ANDA |
| Sildenafil | Sildenafil | tablet, film coated, oral | 72303-0847ANDA |
| Solifenacin succinate | solifenacin succinate | tablet, film coated, oral | 72303-0831ANDA |
| Solifenacin succinate | solifenacin succinate | tablet, film coated, oral | 72303-0832ANDA |
| TADALAFIL | Tadalafil | tablet, film coated, oral | 72303-0822ANDA |
| TADALAFIL | Tadalafil | tablet, film coated, oral | 72303-0823ANDA |
| TADALAFIL | Tadalafil | tablet, film coated, oral | 72303-0824ANDA |
| TADALAFIL | Tadalafil | tablet, film coated, oral | 72303-0825ANDA |
Neighbours
Registered in the same town
5- Yichang Humanwell Pharmaceutical Co., LtdYichang, CHN · 2 sites
- YiChang HEC ChangJiang Pharmaceutical Co., Ltd.Yichang, CHN
- Everest Life Sciences LLCPLAINSBORO, NJ
- Yichang Sanxia Pharmaceutical Co., Ltd.Yichang, CHN
- Yichang Tianren Pharmaceutical Co LtdYichang, CHN
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Enquiry
Common questions
- Is HEC Pharm USA Inc. FDA approved?
- HEC Pharm USA Inc. holds 2 FDA-registered establishments across 2 countries. 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 HEC Pharm USA Inc.'s drugs manufactured?
- At registered sites in China, the United States. The FDA register lists Yichang; Plainsboro, NJ. Registered operations: active ingredient (API) manufacture, labelling.
- What drugs does HEC Pharm USA Inc. make?
- 34 products are listed under HEC Pharm USA Inc. in the openFDA NDC Directory, most often as tablet, film coated; tablet; powder. 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.