Register entryRepackager / relabeller
- Registered sites
- 1
- Active NDC listings
- 91
- 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 |
|---|---|---|---|
| HAWAII REPACK, INC.Registrant: HAWAII REPACK INC | 677 Ala Moana Blvd Ste 700, Honolulu, Hawaii (HI) 96813, United States (USA) | Relabelling, Repackaging | 3037867829137163862 |
Catalogue
Drug listings by form and route
9191 active NDC listings: 81 human prescription drug, 6 bulk ingredient, 2 drug for further processing, 2 human otc drug. By marketing category: ANDA 80, BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING 6, DRUG FOR FURTHER PROCESSING 2, OTC MONOGRAPH DRUG 2, NDA AUTHORIZED GENERIC 1.
| Dosage form | NDCs |
|---|---|
| capsule | 22 |
| tablet | 19 |
| tablet, film coated | 12 |
| capsule, delayed release | 7 |
| kit | 6 |
| powder, for suspension | 6 |
| tablet, delayed release | 4 |
| capsule, delayed release pellets | 3 |
| powder | 2 |
| tablet, orally disintegrating | 2 |
| aerosol, metered | 1 |
| gel | 1 |
| ointment | 1 |
| patch | 1 |
| solution | 1 |
| Route | NDCs |
|---|---|
| oral | 77 |
| topical | 3 |
| cutaneous | 1 |
| ophthalmic | 1 |
| respiratory (inhalation) | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| hawaii repack, inc. | 85 |
| hawaii repack, inc | 6 |
Catalogue
Marketed products
91| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| Albuterol Sulfate | Albuterol Sulfate | aerosol, metered, respiratory (inhalation) | 85534-0039ANDA |
| - | Amitryptline Hydrochloride | kit | 85534-0001BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING |
| - | Amitryptline Hydrochloride | kit | 85534-0002BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING |
| Amoxicillin | Amoxicillin | capsule, oral | 85534-0040ANDA |
| Amoxicillin | Amoxicillin | powder, for suspension, oral | 85534-0070ANDA |
| Amoxicillin | Amoxicillin | powder, for suspension, oral | 85534-0071ANDA |
| Amoxicillin | Amoxicillin | powder, for suspension, oral | 85534-0072ANDA |
| Amoxicillin | Amoxicillin | powder, for suspension, oral | 85534-0073ANDA |
| Amoxicillin and Clavulanate Potassium | Amoxicillin and Clavulanate Potassium | powder, for suspension, oral | 85534-0041ANDA |
| Amoxicillin and Clavulanate Potassium | Amoxicillin and Clavulanate Potassium | powder, for suspension, oral | 85534-0080ANDA |
| Aspirin 81 mg | Aspirin | tablet, coated, oral | 85534-0042OTC MONOGRAPH DRUG |
| BACLOFEN | BACLOFEN | tablet, oral | 85534-0004ANDA |
| Bupropion Hydrochloride | Bupropion Hydrochloride | tablet, extended release, oral | 85534-0006ANDA |
| Butalbital, Acetaminophen, Caffeine | Butalbital, Acetaminophen, and Caffeine | tablet, oral | 85534-0046ANDA |
| CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | tablet, film coated, oral | 85534-0005ANDA |
| CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | tablet, film coated, oral | 85534-0085ANDA |
| CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | tablet, film coated, oral | 85534-0086ANDA |
| Celecoxib | Celecoxib | capsule, oral | 85534-0015ANDA |
| Celecoxib | Celecoxib | capsule, oral | 85534-0066ANDA |
| Celecoxib | Celecoxib | capsule, oral | 85534-0067ANDA |
| Celecoxib | Celecoxib | capsule, oral | 85534-0068ANDA |
| Cephalexin | Cephalexin | capsule, oral | 85534-0076ANDA |
| Cephalexin | Cephalexin | capsule, oral | 85534-0077ANDA |
| Cephalexin | Cephalexin | capsule, oral | 85534-0078ANDA |
| Cephalexin | Cephalexin | capsule, oral | 85534-0079ANDA |
| Ciprofloxacin | Ciprofloxacin Hydrochloride | tablet, film coated, oral | 85534-0047ANDA |
| Ciprofloxacin | Ciprofloxacin Hydrochloride | tablet, film coated, oral | 85534-0069ANDA |
| Ciprofloxacin | Ciprofloxacin Hydrochloride | tablet, film coated, oral | 85534-0081ANDA |
| Clindamycin hydrochloride | Clindamycin hydrochloride | capsule, oral | 85534-0087ANDA |
| Clindamycin hydrochloride | Clindamycin hydrochloride | capsule, oral | 85534-0088ANDA |
| - | Cyclobenzaprine Hydrochloride | kit | 85534-0100BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING |
| - | Cyclobenzaprine Hydrochloride | kit | 85534-0126BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING |
| DICLOFENAC SODIUM | diclofenac sodium | gel, topical | 85534-0089ANDA |
| Diclofenac Epolamine | Diclofenac Epolamine | system, topical | 85534-0034NDA AUTHORIZED GENERIC |
| - | Diclofenac Sodium | powder | 85534-0099DRUG FOR FURTHER PROCESSING |
| - | Diclofenac Sodium | powder | 85534-0127DRUG FOR FURTHER PROCESSING |
| Duloxetine | Duloxetine | capsule, delayed release, oral | 85534-0016ANDA |
| Duloxetine | Duloxetine | capsule, delayed release pellets, oral | 85534-0017ANDA |
| Duloxetine | Duloxetine | capsule, delayed release, oral | 85534-0018ANDA |
| Duloxetine | Duloxetine | capsule, delayed release pellets, oral | 85534-0050ANDA |
| Duloxetine | Duloxetine | capsule, delayed release pellets, oral | 85534-0051ANDA |
| Duloxetine | Duloxetine | capsule, delayed release, oral | 85534-0052ANDA |
| Duloxetine | Duloxetine | capsule, delayed release, oral | 85534-0053ANDA |
| FAMOTIDINE | FAMOTIDINE | tablet, film coated, oral | 85534-0091ANDA |
| FAMOTIDINE | FAMOTIDINE | tablet, film coated, oral | 85534-0092ANDA |
| FLUCONAZOLE | FLUCONAZOLE | tablet, oral | 85534-0049ANDA |
| Gabapentin | Gabapentin | capsule, oral | 85534-0003ANDA |
| Gabapentin | Gabapentin | capsule, oral | 85534-0007ANDA |
| Gabapentin | Gabapentin | capsule, oral | 85534-0008ANDA |
| Gabapentin | Gabapentin | tablet, oral | 85534-0009ANDA |
| Gabapentin | Gabapentin | tablet, oral | 85534-0010ANDA |
| Gabapentin | Gabapentin | capsule, oral | 85534-0054ANDA |
| Gabapentin | Gabapentin | capsule, oral | 85534-0055ANDA |
| Gabapentin | Gabapentin | capsule, oral | 85534-0056ANDA |
| Ibuprofen | Ibuprofen | tablet, oral | 85534-0011ANDA |
| Ibuprofen | Ibuprofen | tablet, oral | 85534-0012ANDA |
| Ibuprofen | Ibuprofen | tablet, oral | 85534-0013ANDA |
| Levofloxacin | Levofloxacin | tablet, film coated, oral | 85534-0096ANDA |
| Levofloxacin | Levofloxacin | tablet, film coated, oral | 85534-0097ANDA |
| Levofloxacin | Levofloxacin | tablet, film coated, oral | 85534-0098ANDA |
| - | Lidocaine Hydrochloride | kit | 85534-0101BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING |
| - | Lidocaine Hydrochloride | kit | 85534-0128BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING |
| METHYLPREDNISOLONE | METHYLPREDNISOLONE | tablet, oral | 85534-0035ANDA |
| Methocarbamol | methocarbamol | tablet, oral | 85534-0021ANDA |
| Methocarbamol | methocarbamol | tablet, oral | 85534-0022ANDA |
| Methocarbamol | methocarbamol | tablet, oral | 85534-0057ANDA |
| Naproxen | Naproxen | tablet, oral | 85534-0023ANDA |
| Naproxen | Naproxen | tablet, oral | 85534-0024ANDA |
| Naproxen | Naproxen | tablet, oral | 85534-0058ANDA |
| Olu Pain Management | lidocaine and camphor | patch, cutaneous | 85534-0102OTC MONOGRAPH DRUG |
| Omeprazole | Omeprazole | capsule, delayed release, oral | 85534-0036ANDA |
| Omeprazole | Omeprazole | capsule, delayed release, oral | 85534-0037ANDA |
| Omeprazole | Omeprazole | capsule, delayed release, oral | 85534-0064ANDA |
| Ondansetron | Ondansetron | tablet, orally disintegrating, oral | 85534-0025ANDA |
| Ondansetron | Ondansetron | tablet, orally disintegrating, oral | 85534-0063ANDA |
| PANTOPRAZOLE SODIUM | PANTOPRAZOLE | tablet, delayed release, oral | 85534-0028ANDA |
| PANTOPRAZOLE SODIUM | PANTOPRAZOLE | tablet, delayed release, oral | 85534-0062ANDA |
| Pantoprazole Sodium | Pantoprazole Sodium | tablet, delayed release, oral | 85534-0027ANDA |
| Pantoprazole Sodium | Pantoprazole Sodium | tablet, delayed release, oral | 85534-0061ANDA |
| Paroxetine | Paroxetine | tablet, film coated, oral | 85534-0026ANDA |
| Tizanidine | Tizanidine | tablet, oral | 85534-0029ANDA |
| Tizanidine | Tizanidine | tablet, oral | 85534-0030ANDA |
| celecoxib | celecoxib | capsule, oral | 85534-0014ANDA |
| celecoxib | celecoxib | capsule, oral | 85534-0059ANDA |
| celecoxib | celecoxib | capsule, oral | 85534-0060ANDA |
| celecoxib | celecoxib | capsule, oral | 85534-0065ANDA |
| ciprofloxacin | Ciprofloxacin | solution, ophthalmic | 85534-0075ANDA |
| doxycycline hyclate | doxycycline hyclate | capsule, oral | 85534-0048ANDA |
| meloxicam | meloxicam | tablet, oral | 85534-0019ANDA |
| meloxicam | meloxicam | tablet, oral | 85534-0020ANDA |
| mupirocin | Mupirocin | ointment, topical | 85534-0038ANDA |
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Enquiry
Common questions
- Is HAWAII REPACK INC FDA approved?
- HAWAII REPACK 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 HAWAII REPACK INC's registered sites?
- The FDA register lists Honolulu, HI. Registered operations: relabelling, repackaging.
- What drugs does HAWAII REPACK INC make?
- 91 products are listed under HAWAII REPACK INC in the openFDA NDC Directory, most often as capsule; tablet; tablet, film 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.