Register entryRepackager / relabeller
- Registered sites
- 1
- Active NDC listings
- 50
- Labeller names
- 2
- Live patents
- 0
- Countries
- 1
- Base
- United States
Authorisation
Registered operations
Relabelling1Repackaging1
Sites
Registered establishments
1| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Prodose, Inc. | 2004 Orville Drive North, RONKONKOMA, New York (NY) 11779, United States (USA) | Relabelling, Repackaging | 3011773798119371190 |
Catalogue
Drug listings by form and route
5050 active NDC listings: 42 drug for further processing, 8 human otc drug. By marketing category: DRUG FOR FURTHER PROCESSING 42, OTC MONOGRAPH DRUG 7, ANDA 1.
| Dosage form | NDCs |
|---|---|
| capsule, liquid filled | 21 |
| tablet, film coated | 11 |
| capsule, gelatin coated | 8 |
| tablet | 5 |
| tablet, coated | 2 |
| capsule | 1 |
| solution/ drops | 1 |
| spray | 1 |
| Route | NDCs |
|---|---|
| oral | 6 |
| nasal | 1 |
| ophthalmic | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| prodose, inc. | 47 |
| prodose, inc | 3 |
Catalogue
Marketed products
50| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| - | ACETAMINOPHEN and CAFFEINE | tablet | 68210-1021DRUG FOR FURTHER PROCESSING |
| - | ACETAMINOPHEN and DIPHENHYDRAMINE CITRATE | tablet, film coated | 68210-1012DRUG FOR FURTHER PROCESSING |
| - | ACETAMINOPHEN and DIPHENHYDRAMINE HYDROCHLORIDE | tablet, film coated | 68210-0008DRUG FOR FURTHER PROCESSING |
| - | ACETAMINOPHEN, ASPIRIN, and CAFFEINE | tablet, coated | 68210-1013DRUG FOR FURTHER PROCESSING |
| - | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE and PHENYLEPHRINE HYDROCHLORIDE | capsule, gelatin coated | 68210-4117DRUG FOR FURTHER PROCESSING |
| - | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDE | capsule, gelatin coated | 68210-4115DRUG FOR FURTHER PROCESSING |
| - | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE | capsule, liquid filled | 68210-4206DRUG FOR FURTHER PROCESSING |
| - | ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE | capsule, gelatin coated | 68210-4114DRUG FOR FURTHER PROCESSING |
| - | ASPIRIN | tablet, film coated | 68210-1015DRUG FOR FURTHER PROCESSING |
| - | Acetaminophen | tablet, film coated | 68210-1014DRUG FOR FURTHER PROCESSING |
| - | Acetaminophen | tablet, film coated | 68210-4203DRUG FOR FURTHER PROCESSING |
| - | Acetaminophen | capsule, liquid filled | 68210-5047DRUG FOR FURTHER PROCESSING |
| - | Acetaminophen | capsule, liquid filled | 68210-5055DRUG FOR FURTHER PROCESSING |
| - | Acetaminophen 250mg, Aspirin 250mg and Caffeine 65mg soft gelatin capsules(Gel Tabs) | tablet, coated | 68210-5070DRUG FOR FURTHER PROCESSING |
| - | Acetaminophen, Aspirin, Caffeine | tablet, film coated | 68210-4186DRUG FOR FURTHER PROCESSING |
| - | Acetaminophen, Dextromethorphan HBr ,Guaifenesin | capsule, liquid filled | 68210-5061DRUG FOR FURTHER PROCESSING |
| - | Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate | capsule, liquid filled | 68210-5062DRUG FOR FURTHER PROCESSING |
| - | Acetaminophen, Dextromethorphan HBr and Phenylephrine Hcl | capsule, liquid filled | 68210-5064DRUG FOR FURTHER PROCESSING |
| - | Acetaminophen, Dextromethorphan HBr, Guaifenesin | tablet, film coated | 68210-5052DRUG FOR FURTHER PROCESSING |
| - | Acetaminophen, Dextromethorphan Hydrobromide | capsule, liquid filled | 68210-5078DRUG FOR FURTHER PROCESSING |
| - | Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate | capsule, liquid filled | 68210-5042DRUG FOR FURTHER PROCESSING |
| Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride | Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride | capsule, liquid filled, oral | 68210-5053OTC MONOGRAPH DRUG |
| - | Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine succinate and Phenylephrine Hydrochloride | capsule, liquid filled | 68210-5050DRUG FOR FURTHER PROCESSING |
| Allergy Relief | Cetirizine Hydrochloride | tablet, film coated, oral | 68210-4159ANDA |
| - | Cetirizine Hydrochloride 10 mg | tablet | 68210-4051DRUG FOR FURTHER PROCESSING |
| - | DEXTROMETHORPHAN HYDROBROMIDE | capsule, gelatin coated | 68210-4074DRUG FOR FURTHER PROCESSING |
| - | DIPHENHYDRAMINE HYDROCHLORIDE | tablet, film coated | 68210-1016DRUG FOR FURTHER PROCESSING |
| - | DIPHENHYDRAMINE HYDROCHLORIDE | capsule, liquid filled | 68210-5045DRUG FOR FURTHER PROCESSING |
| - | DIPHENHYDRAMINE HYDROCHLORIDE | capsule, liquid filled | 68210-5046DRUG FOR FURTHER PROCESSING |
| DIPHENHYDRAMINE HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE | capsule, liquid filled, oral | 68210-5057OTC MONOGRAPH DRUG |
| - | Dextromethorphan Hydrobromide | capsule, liquid filled | 68210-5054DRUG FOR FURTHER PROCESSING |
| - | Dextromethorphan Hydrobromide | capsule, liquid filled | 68210-5060DRUG FOR FURTHER PROCESSING |
| - | Diphenhydramihe hydrochloride | capsule, gelatin coated | 68210-4073DRUG FOR FURTHER PROCESSING |
| - | Diphenhydramine Hydrochloride | tablet, film coated | 68210-1020DRUG FOR FURTHER PROCESSING |
| - | Docusate Sodium and Sennosides | capsule, liquid filled | 68210-5051DRUG FOR FURTHER PROCESSING |
| - | Docusate Sodium and Sennosides | capsule, liquid filled | 68210-5066DRUG FOR FURTHER PROCESSING |
| - | Guaifenesin | tablet | 68210-0116DRUG FOR FURTHER PROCESSING |
| - | Guaifenesin and Dextromethorphan HBr | capsule, gelatin coated | 68210-4071DRUG FOR FURTHER PROCESSING |
| - | Guaifenesin and Dextromethorphan HBr | capsule, gelatin coated | 68210-4072DRUG FOR FURTHER PROCESSING |
| - | Guaifenesin and Dextromethorphan HBr | capsule, gelatin coated | 68210-5041DRUG FOR FURTHER PROCESSING |
| - | Guaifenesin,Dextromethorphan Hbr | capsule, liquid filled | 68210-5044DRUG FOR FURTHER PROCESSING |
| - | Guaifenesin,Dextromethorphan Hbr | capsule, liquid filled | 68210-5058DRUG FOR FURTHER PROCESSING |
| - | Loratadine 10 mg | tablet | 68210-4122DRUG FOR FURTHER PROCESSING |
| MUCUS RELIEF | GUAIFENESIN | tablet, oral | 68210-4158OTC MONOGRAPH DRUG |
| Maximum Strength Nighttime Severe Cold and Flu | Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride | capsule, liquid filled, oral | 68210-4210OTC MONOGRAPH DRUG |
| NIGHTTIME SLEEP AID | DIPHENHYDRAMINE HYDROCHLORIDE | capsule, liquid filled, oral | 68210-4160OTC MONOGRAPH DRUG |
| Oxymetazoline hydrochloride | Oxymetazoline hydrochloride | spray, nasal | 68210-5056OTC MONOGRAPH DRUG |
| - | SENNOSIDES | tablet, film coated | 68210-1017DRUG FOR FURTHER PROCESSING |
| Value Health by Prodose Eye Drops | TETRAHYDROZOLINE HYDROCHLORIDE and Polyethylene Glycol 400 | solution/ drops, ophthalmic | 68210-5059OTC MONOGRAPH DRUG |
| - | omega-3 fish oil | capsule | 68210-5069DRUG FOR FURTHER PROCESSING |
Neighbours
Registered in the same town
2- LS Promotions INCRonkonkoma, NY
- Shield Pharmaceuticals CorpRonkonkoma, NY
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Enquiry
Common questions
- Is Prodose, Inc. FDA approved?
- Prodose, 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 Prodose, Inc.'s registered sites?
- The FDA register lists RONKONKOMA, NY. Registered operations: relabelling, repackaging.
- What drugs does Prodose, Inc. make?
- 50 products are listed under Prodose, Inc. in the openFDA NDC Directory, most often as capsule, liquid filled; tablet, film coated; capsule, gelatin coated. 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.