Register entryRepackager / relabeller
- Registered sites
- 1
- Active NDC listings
- 4
- Live patents
- 0
- Countries
- 1
- Base
- United States
Authorisation
Registered operations
Labelling1Relabelling1
Sites
Registered establishments
1| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Safrel Pharmaceuticals, LLCRegistrant: Safrel Pharmaceuticals LLC | 178 Ridge Rd Ste H, Dayton, New Jersey (NJ) 08810, United States (USA) | Labelling, Relabelling | 3042030663144957056 |
Catalogue
Drug listings by form and route
44 active NDC listings: 4 human otc drug. By marketing category: ANDA 3, OTC MONOGRAPH DRUG 1.
| Dosage form | NDCs |
|---|---|
| tablet | 3 |
| tablet, extended release | 1 |
| Route | NDCs |
|---|---|
| oral | 4 |
| Labeller name on the listing | NDCs |
|---|---|
| safrel pharmaceuticals, llc. | 4 |
Catalogue
Marketed products
4| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| Acetaminophen, Aspirin and Caffeine | Acetaminophen, Aspirin and Caffeine | tablet, oral | 71309-079ANDA |
| Extra Strength No-Pain | Acetaminophen | tablet, oral | 71309-001OTC MONOGRAPH DRUG |
| Fexofenadine Hydrochloride | Fexofenadine Hydrochloride | tablet, oral | 71309-091ANDA |
| GUAIFENESIN | GUAIFENESIN | tablet, extended release, oral | 71309-461ANDA |
Neighbours
Registered in the same town
3- Reliable Healthcare Logistics, LLCDayton, NJ
- Aurolife Pharma LLCDayton, NJ
- Guardian Drug Company, Inc.Dayton, NJ
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Enquiry
Common questions
- Is Safrel Pharmaceuticals LLC FDA approved?
- Safrel Pharmaceuticals LLC 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 Safrel Pharmaceuticals LLC's registered sites?
- The FDA register lists Dayton, NJ. Registered operations: labelling, relabelling.
- What drugs does Safrel Pharmaceuticals LLC make?
- 4 products are listed under Safrel Pharmaceuticals LLC in the openFDA NDC Directory, most often as tablet; tablet, extended release. 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.