Register entry
- Registered sites
- 3
- Active NDC listings
- 49
- Labeller names
- 3
- Live patents
- 0
- Countries
- 2
- Base
- United States
Authorisation
Registered operations
Analytical testing1Active ingredient (API) manufacture2Finished drug manufacture3Packaging1
Sites
Registered establishments
3| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Adare Pharmaceuticals Srl | Via Martin Luther King, 13, Pessano Con Bornago, (MI) 20042, Italy (ITA) | Active ingredient (API) manufacture, Finished drug manufacture | 1000573478435676661 |
| Adare Pharmaceuticals USA, Inc. | 8006 Reeder Street, Lenexa, Kansas (KS) 66214, United States (USA) | Finished drug manufacture | 3012147531828536438 |
| Adare Pharmaceuticals, Inc. | 845 Center Dr., Vandalia, Ohio (OH) 45377-3129, United States (USA) | Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture, Packaging | 1525864079819927 |
Catalogue
Drug listings by form and route
4949 active NDC listings: 47 drug for further processing, 2 human prescription drug. By marketing category: DRUG FOR FURTHER PROCESSING 47, ANDA 2.
| Dosage form | NDCs |
|---|---|
| capsule | 19 |
| capsule, extended release | 9 |
| powder | 8 |
| tablet, orally disintegrating | 8 |
| capsule, delayed release | 2 |
| tablet, extended release | 2 |
| bead | 1 |
| Route | NDCs |
|---|---|
| oral | 2 |
| Labeller name on the listing | NDCs |
|---|---|
| adare pharmaceuticals inc | 33 |
| adare pharmaceuticals srl | 9 |
| adare pharmaceuticals, inc. | 7 |
Catalogue
Marketed products
49| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| - | Acetaminophen | powder | 57298-050DRUG FOR FURTHER PROCESSING |
| - | Acetaminophen | powder | 59917-026DRUG FOR FURTHER PROCESSING |
| - | Amphetamine Sulfate | tablet, orally disintegrating | 59917-225DRUG FOR FURTHER PROCESSING |
| - | Amphetamine Sulfate | tablet, orally disintegrating | 59917-226DRUG FOR FURTHER PROCESSING |
| - | Amphetamine Sulfate | tablet, orally disintegrating | 59917-227DRUG FOR FURTHER PROCESSING |
| - | Amphetamine Sulfate | tablet, orally disintegrating | 59917-228DRUG FOR FURTHER PROCESSING |
| - | Cyclobenzaprine Hydrochloride | capsule, extended release | 59917-090DRUG FOR FURTHER PROCESSING |
| - | Cyclobenzaprine Hydrochloride | capsule, extended release | 59917-091DRUG FOR FURTHER PROCESSING |
| - | DIPHENHYDRAMINE HYDROCHLORIDE | powder | 59917-089DRUG FOR FURTHER PROCESSING |
| - | Dexmethylphenidate Hydrochloride | capsule | 59917-122DRUG FOR FURTHER PROCESSING |
| - | Dexmethylphenidate Hydrochloride | capsule | 59917-123DRUG FOR FURTHER PROCESSING |
| - | Dexmethylphenidate Hydrochloride | capsule | 59917-124DRUG FOR FURTHER PROCESSING |
| - | Dexmethylphenidate Hydrochloride | capsule | 59917-126DRUG FOR FURTHER PROCESSING |
| - | Dexmethylphenidate Hydrochloride | capsule | 59917-127DRUG FOR FURTHER PROCESSING |
| - | Dexmethylphenidate Hydrochloride | capsule | 59917-128DRUG FOR FURTHER PROCESSING |
| - | Dexmethylphenidate Hydrochloride | capsule | 59917-129DRUG FOR FURTHER PROCESSING |
| - | Ibuprofen | powder | 59917-025DRUG FOR FURTHER PROCESSING |
| - | Lamotrigine | tablet, orally disintegrating | 59917-077DRUG FOR FURTHER PROCESSING |
| - | Lamotrigine | tablet, orally disintegrating | 59917-078DRUG FOR FURTHER PROCESSING |
| - | Lamotrigine | tablet, orally disintegrating | 59917-079DRUG FOR FURTHER PROCESSING |
| - | Lamotrigine | tablet, orally disintegrating | 59917-080DRUG FOR FURTHER PROCESSING |
| - | Microcaps Light Liquid Paraffin | bead | 59917-087DRUG FOR FURTHER PROCESSING |
| POTASSIUM CHLORIDE EXTENDED RELEASE | POTASSIUM CHLORIDE | capsule, oral | 59917-102ANDA |
| POTASSIUM CHLORIDE EXTENDED RELEASE | POTASSIUM CHLORIDE | capsule, oral | 59917-103ANDA |
| - | Pancrelipase | capsule | 57298-802DRUG FOR FURTHER PROCESSING |
| - | Pancrelipase | capsule | 57298-803DRUG FOR FURTHER PROCESSING |
| - | Pancrelipase | capsule | 57298-804DRUG FOR FURTHER PROCESSING |
| - | Pancrelipase | capsule | 57298-805DRUG FOR FURTHER PROCESSING |
| - | Pancrelipase | capsule | 57298-806DRUG FOR FURTHER PROCESSING |
| - | Pancrelipase | capsule | 57298-807DRUG FOR FURTHER PROCESSING |
| - | Pancrelipase Zenpep (pancrelipase) delayed-release bulk capsules | capsule, delayed release | 57298-808DRUG FOR FURTHER PROCESSING |
| - | Pancrelipase Zenpep (pancrelipase) delayed-release capsules | capsule, delayed release | 57298-801DRUG FOR FURTHER PROCESSING |
| - | Potassium Chloride | tablet, extended release | 59917-047DRUG FOR FURTHER PROCESSING |
| - | Potassium Chloride | powder | 59917-054DRUG FOR FURTHER PROCESSING |
| - | Potassium Chloride | powder | 59917-055DRUG FOR FURTHER PROCESSING |
| - | Potassium Chloride | powder | 59917-057DRUG FOR FURTHER PROCESSING |
| - | Potassium Chloride | powder | 59917-058DRUG FOR FURTHER PROCESSING |
| - | Potassium Chloride | tablet, extended release | 59917-117DRUG FOR FURTHER PROCESSING |
| - | Propranolol HCl | capsule, extended release | 59917-118DRUG FOR FURTHER PROCESSING |
| - | Propranolol HCl | capsule | 59917-119DRUG FOR FURTHER PROCESSING |
| - | Propranolol HCl | capsule, extended release | 59917-120DRUG FOR FURTHER PROCESSING |
| - | Propranolol HCl | capsule, extended release | 59917-121DRUG FOR FURTHER PROCESSING |
| - | Propranolol Hydrochloride | capsule, extended release | 59917-092DRUG FOR FURTHER PROCESSING |
| - | Propranolol Hydrochloride | capsule, extended release | 59917-093DRUG FOR FURTHER PROCESSING |
| - | Propranolol Hydrochloride | capsule, extended release | 59917-094DRUG FOR FURTHER PROCESSING |
| - | Propranolol Hydrochloride | capsule, extended release | 59917-095DRUG FOR FURTHER PROCESSING |
| - | valbenazine | capsule | 59917-254DRUG FOR FURTHER PROCESSING |
| - | valbenazine | capsule | 59917-255DRUG FOR FURTHER PROCESSING |
| - | valbenazine | capsule | 59917-256DRUG FOR FURTHER PROCESSING |
Neighbours
Registered in the same town
3- Elanco US Inc.Lenexa, KS
- Axogen CorporationVandalia, OH
- BF ASCHER AND CO INCLENEXA, KS
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Enquiry
Common questions
- Is Adare Pharmaceuticals USA, Inc. FDA approved?
- Adare Pharmaceuticals USA, Inc. holds 3 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 Adare Pharmaceuticals USA, Inc.'s drugs manufactured?
- At registered sites in Italy, the United States. The FDA register lists Pessano Con Bornago, MI; Lenexa, KS; Vandalia, OH. Registered operations: analytical testing, active ingredient (API) manufacture, finished drug manufacture, packaging.
- What drugs does Adare Pharmaceuticals USA, Inc. make?
- 49 products are listed under Adare Pharmaceuticals USA, Inc. in the openFDA NDC Directory, most often as capsule; capsule, extended release; 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.