Register entryRepackager / relabeller
- Registered sites
- 1
- Active NDC listings
- 29
- Labeller names
- 3
- Live patents
- 0
- Countries
- 1
- Base
- United States
Sites
Registered establishments
1| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Legacy Pharma USA Inc. | 15169 N Scottsdale Rd, Ste 205, Scattsdale, Arizona (AZ) 85254-2665, United States (USA) | Labelling | 3038507464118831776 |
Catalogue
Drug listings by form and route
2929 active NDC listings: 28 human prescription drug, 1 drug for further processing. By marketing category: NDA 19, ANDA 7, UNAPPROVED DRUG OTHER 2, DRUG FOR FURTHER PROCESSING 1.
| Dosage form | NDCs |
|---|---|
| tablet | 11 |
| capsule | 5 |
| cream | 4 |
| lotion | 3 |
| ointment | 2 |
| tablet, coated | 2 |
| gel | 1 |
| injection | 1 |
| Route | NDCs |
|---|---|
| oral | 17 |
| topical | 10 |
| intravenous | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| legacy pharma usa inc. | 17 |
| legacy pharma usa, inc. | 11 |
| legacy pharma usa inc | 1 |
Catalogue
Marketed products
29| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| Analpram HC | hydrocortisone acetate and pramoxine hydrochloride | cream, topical | 83107-018ANDA |
| Analpram HC | hydrocortisone acetate and pramoxine hydrochloride | cream, topical | 83107-019ANDA |
| Analpram HC | hydrocortisone acetate and pramoxine hydrochloride | lotion, topical | 83107-020ANDA |
| BETAPACE | sotalol hydrochloride | tablet, oral | 83107-005NDA |
| BETAPACE | sotalol hydrochloride | tablet, oral | 83107-006NDA |
| BETAPACE | sotalol hydrochloride | tablet, oral | 83107-007NDA |
| BETAPACE AF | sotalol hydrochloride | tablet, oral | 83107-008NDA |
| BETAPACE AF | sotalol hydrochloride | tablet, oral | 83107-009NDA |
| BETAPACE AF | sotalol hydrochloride | tablet, oral | 83107-010NDA |
| BRISDELLE | paroxetine | capsule, oral | 83107-027NDA |
| ESBRIET | PIRFENIDONE | tablet, coated, oral | 83107-028NDA |
| ESBRIET | PIRFENIDONE | tablet, coated, oral | 83107-029NDA |
| Ethyol | Amifostine | injection, intravenous | 83107-030NDA |
| IMURAN | azathioprine | tablet, oral | 83107-025NDA |
| LOTRONEX | alosetron hydrochloride | tablet, oral | 83107-012NDA |
| LOTRONEX | alosetron hydrochloride | tablet, oral | 83107-013NDA |
| Motofen | difenoxin and atropine sulfate | tablet, oral | 83107-011NDA |
| Naftin | Naftifine Hydrochloride | gel, topical | 83107-023NDA |
| Pramosone | hydrocortisone acetate and pramoxine hydrochloride | ointment, topical | 83107-014UNAPPROVED DRUG OTHER |
| Pramosone | hydrocortisone acetate and pramoxine hydrochloride | lotion, topical | 83107-021ANDA |
| Pramosone | hydrocortisone acetate and pramoxine hydrochloride | lotion, topical | 83107-022ANDA |
| Pramosone Cream | hydrocortisone acetate and pramoxine hydrochloride | cream, topical | 83107-016ANDA |
| Pramosone Cream | hydrocortisone acetate and pramoxine hydrochloride | cream, topical | 83107-017ANDA |
| Zanaflex | tizanidine hydrochloride | capsule, oral | 83107-001NDA |
| Zanaflex | tizanidine hydrochloride | capsule, oral | 83107-002NDA |
| Zanaflex | tizanidine hydrochloride | capsule, oral | 83107-003NDA |
| Zanaflex | tizanidine hydrochloride | tablet, oral | 83107-004NDA |
| - | paroxetine | capsule | 83107-031DRUG FOR FURTHER PROCESSING |
| pramosone | hydrocortisone acetate and pramoxine hydrochloride | ointment, topical | 83107-015UNAPPROVED DRUG OTHER |
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Enquiry
Common questions
- Is Legacy Pharma USA Inc. FDA approved?
- Legacy Pharma USA Inc. holds 1 FDA-registered establishment 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 Legacy Pharma USA Inc.'s registered sites?
- The FDA register lists Scattsdale, AZ. Registered operations: labelling.
- What drugs does Legacy Pharma USA Inc. make?
- 29 products are listed under Legacy Pharma USA Inc. in the openFDA NDC Directory, most often as tablet; capsule; cream. 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.