Register entry
- Registered sites
- 1
- Active NDC listings
- 55
- Live patents
- 0
- Countries
- 1
- Base
- United States
Authorisation
Registered operations
Analytical testing1Labelling1Finished drug manufacture1Packaging1
Sites
Registered establishments
1| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Societal CDMO Gainesville, LLC | 1300 Gould Drive, Gainesville, Georgia (GA) 30504, United States (USA) | Analytical testing, Labelling, Finished drug manufacture, Packaging | 1035761057585150 |
Catalogue
Drug listings by form and route
5555 active NDC listings: 55 drug for further processing. By marketing category: DRUG FOR FURTHER PROCESSING 55.
| Dosage form | NDCs |
|---|---|
| capsule, extended release | 45 |
| tablet | 6 |
| capsule | 4 |
| Route | NDCs |
|---|
| Labeller name on the listing | NDCs |
|---|---|
| societal cdmo gainesville, llc | 55 |
Catalogue
Marketed products
55| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| - | brexpiprazole | tablet | 60274-935DRUG FOR FURTHER PROCESSING |
| - | brexpiprazole | tablet | 60274-936DRUG FOR FURTHER PROCESSING |
| - | brexpiprazole | tablet | 60274-937DRUG FOR FURTHER PROCESSING |
| - | brexpiprazole | tablet | 60274-938DRUG FOR FURTHER PROCESSING |
| - | brexpiprazole | tablet | 60274-939DRUG FOR FURTHER PROCESSING |
| - | brexpiprazole | tablet | 60274-940DRUG FOR FURTHER PROCESSING |
| - | dexmethylphenidate hydrochloride | capsule, extended release | 60274-305DRUG FOR FURTHER PROCESSING |
| - | dexmethylphenidate hydrochloride | capsule, extended release | 60274-310DRUG FOR FURTHER PROCESSING |
| - | dexmethylphenidate hydrochloride | capsule, extended release | 60274-315DRUG FOR FURTHER PROCESSING |
| - | dexmethylphenidate hydrochloride | capsule, extended release | 60274-320DRUG FOR FURTHER PROCESSING |
| - | dexmethylphenidate hydrochloride | capsule, extended release | 60274-325DRUG FOR FURTHER PROCESSING |
| - | dexmethylphenidate hydrochloride | capsule, extended release | 60274-330DRUG FOR FURTHER PROCESSING |
| - | dexmethylphenidate hydrochloride | capsule, extended release | 60274-335DRUG FOR FURTHER PROCESSING |
| - | dexmethylphenidate hydrochloride | capsule, extended release | 60274-340DRUG FOR FURTHER PROCESSING |
| - | dexmethylphenidate hydrochloride | capsule, extended release | 60274-705DRUG FOR FURTHER PROCESSING |
| - | dexmethylphenidate hydrochloride | capsule, extended release | 60274-710DRUG FOR FURTHER PROCESSING |
| - | dexmethylphenidate hydrochloride | capsule, extended release | 60274-715DRUG FOR FURTHER PROCESSING |
| - | dexmethylphenidate hydrochloride | capsule, extended release | 60274-720DRUG FOR FURTHER PROCESSING |
| - | dexmethylphenidate hydrochloride | capsule, extended release | 60274-725DRUG FOR FURTHER PROCESSING |
| - | dexmethylphenidate hydrochloride | capsule, extended release | 60274-730DRUG FOR FURTHER PROCESSING |
| - | dexmethylphenidate hydrochloride | capsule, extended release | 60274-735DRUG FOR FURTHER PROCESSING |
| - | dexmethylphenidate hydrochloride | capsule, extended release | 60274-740DRUG FOR FURTHER PROCESSING |
| - | dexmethylphenidate hydrochloride | capsule, extended release | 60274-745DRUG FOR FURTHER PROCESSING |
| - | dexmethylphenidate hydrochloride | capsule, extended release | 60274-750DRUG FOR FURTHER PROCESSING |
| - | dexmethylphenidate hydrochloride | capsule, extended release | 60274-755DRUG FOR FURTHER PROCESSING |
| - | dexmethylphenidate hydrochloride | capsule, extended release | 60274-760DRUG FOR FURTHER PROCESSING |
| - | dexmethylphenidate hydrochloride | capsule, extended release | 60274-765DRUG FOR FURTHER PROCESSING |
| - | dexmethylphenidate hydrochloride | capsule, extended release | 60274-770DRUG FOR FURTHER PROCESSING |
| - | dexmethylphenidate hydrochloride | capsule, extended release | 60274-775DRUG FOR FURTHER PROCESSING |
| - | dexmethylphenidate hydrochloride | capsule, extended release | 60274-780DRUG FOR FURTHER PROCESSING |
| - | methylphenidate hydrochloride | capsule, extended release | 60274-101DRUG FOR FURTHER PROCESSING |
| - | methylphenidate hydrochloride | capsule, extended release | 60274-102DRUG FOR FURTHER PROCESSING |
| - | methylphenidate hydrochloride | capsule, extended release | 60274-103DRUG FOR FURTHER PROCESSING |
| - | methylphenidate hydrochloride | capsule, extended release | 60274-104DRUG FOR FURTHER PROCESSING |
| - | methylphenidate hydrochloride | capsule, extended release | 60274-542DRUG FOR FURTHER PROCESSING |
| - | methylphenidate hydrochloride | capsule, extended release | 60274-546DRUG FOR FURTHER PROCESSING |
| - | methylphenidate hydrochloride | capsule, extended release | 60274-547DRUG FOR FURTHER PROCESSING |
| - | methylphenidate hydrochloride | capsule, extended release | 60274-548DRUG FOR FURTHER PROCESSING |
| - | methylphenidate hydrochloride | capsule, extended release | 60274-549DRUG FOR FURTHER PROCESSING |
| - | methylphenidate hydrochloride | capsule, extended release | 60274-551DRUG FOR FURTHER PROCESSING |
| - | methylphenidate hydrochloride | capsule, extended release | 60274-552DRUG FOR FURTHER PROCESSING |
| - | methylphenidate hydrochloride | capsule, extended release | 60274-553DRUG FOR FURTHER PROCESSING |
| - | methylphenidate hydrochloride | capsule, extended release | 60274-554DRUG FOR FURTHER PROCESSING |
| - | methylphenidate hydrochloride | capsule, extended release | 60274-942DRUG FOR FURTHER PROCESSING |
| - | methylphenidate hydrochloride | capsule, extended release | 60274-946DRUG FOR FURTHER PROCESSING |
| - | methylphenidate hydrochloride | capsule, extended release | 60274-947DRUG FOR FURTHER PROCESSING |
| - | methylphenidate hydrochloride | capsule, extended release | 60274-948DRUG FOR FURTHER PROCESSING |
| - | methylphenidate hydrochloride | capsule, extended release | 60274-949DRUG FOR FURTHER PROCESSING |
| - | verapamil hydrochloride | capsule, extended release | 60274-100DRUG FOR FURTHER PROCESSING |
| - | verapamil hydrochloride | capsule | 60274-120DRUG FOR FURTHER PROCESSING |
| - | verapamil hydrochloride | capsule | 60274-180DRUG FOR FURTHER PROCESSING |
| - | verapamil hydrochloride | capsule, extended release | 60274-200DRUG FOR FURTHER PROCESSING |
| - | verapamil hydrochloride | capsule | 60274-240DRUG FOR FURTHER PROCESSING |
| - | verapamil hydrochloride | capsule, extended release | 60274-300DRUG FOR FURTHER PROCESSING |
| - | verapamil hydrochloride | capsule | 60274-360DRUG FOR FURTHER PROCESSING |
Neighbours
Registered in the same town
1- Apotheca CompanyGainesville, GA
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Enquiry
Common questions
- Is Societal CDMO Gainesville, LLC FDA approved?
- Societal CDMO Gainesville, 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 Societal CDMO Gainesville, LLC's drugs manufactured?
- The FDA register lists Gainesville, GA. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.
- What drugs does Societal CDMO Gainesville, LLC make?
- 55 products are listed under Societal CDMO Gainesville, LLC in the openFDA NDC Directory, most often as capsule, extended release; tablet; capsule. 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.