Drug company (FDA labeler)
Hawaii Repack, Inc.
Name in FDA records: HAWAII REPACK, INC.
NDC labeler code: 85534
What is a labeler?
The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.
Official FDA data only
Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.
Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.
Prescription medicines
- CelecoxibCelebrex, Vyscoxa, Elyxyb - Celecoxib · 8 products
- GabapentinNeurontin, Gralise, Relgaabi · 8 products
- DuloxetineDrizalma Sprinkle · 7 products
- AmoxicillinAmoxil · 5 products
- CiprofloxacinCiprofloxacin in Dextrose, Cipro, Ciloxan · 4 products
- Cephalexin4 products
- Pantoprazole sodiumProtonix I.V., Protonix Delayed-Release, Pantoprazole Sodium I.V. · 4 products
- OmeprazolePrilosec · 3 products
- Levofloxacin3 products
- IbuprofenIbu, Caldolor · 3 products
- Cyclobenzaprine hydrochlorideAmrix, Tonmya, Fexmid · 3 products
- MethocarbamolRobaxin, Atmeksi, Tanlor · 3 products
- NaproxenNaprelan, Rugby All Day Relief · 3 products
- Ondansetron2 products
- ClindamycinCleocin Phosphate, Cleocin Hydrochloride, Clindamycin Phoaphate Topical Solution Usp, 1% · 2 products
- FamotidinePepcid · 2 products
- Amoxicillin and clavulanate potassium (amoxicillin / clavulanate)Augmentin Es-600, Augmentin · 2 products
- MeloxicamZybic, Xifyrm, Qamzova · 2 products
- TizanidineZanaflex, Ontralfy · 2 products
- BupropionWellbutrin SR, Aplenzin, Wellbutrin XL · 1 product
- Butalbital, acetaminophen and caffeineFioricet · 1 product
- DiclofenacZipsor, Lofena, Cambia · 1 product
- MupirocinPirnuo · 1 product
- BaclofenGablofen, Lyvispah, Baclofen (Intrathecal) · 1 product
- Diclofenac epolamineLicart, Flector, Diclox Patch 30ct · 1 product
- ParoxetinePaxil, Paxil CR, Brisdelle · 1 product
- MethylprednisoloneSolu-Medrol, Medrol · 1 product
- FluconazoleDiflucan · 1 product
- DoxycyclineDoxy 100, Acticlate Cap, Doryx Mpc · 1 product
- Albuterol sulfateVentolin HFA, Albuterol Sulate HFA, Proair Respiclick · 1 product
FDA applications for these products
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| January 7, 2022 | ANDA215630 | Famotidine FAMOTIDINE | Vkt Pharma |
| July 13, 2021 | ANDA214099 | Baclofen BACLOFEN | Aurobindo Pharma Ltd |
| June 1, 2021 | ANDA207085 | Albuterol sulfate ALBUTEROL SULFATE | Sandoz |
| December 3, 2020 | ANDA205129 | Celecoxib CELECOXIB | Sciegen Pharms |
| May 8, 2020 | ANDA213794 | Ibuprofen IBUPROFEN | Aurobindo Pharma Ltd |
| February 21, 2020 | ANDA212517 | Naproxen NAPROXEN | Sciegen Pharms |
| October 31, 2018 | ANDA209587 | Butalbital, acetaminophen and caffeine BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | Lgm Pharma |
| May 14, 2018 | ANDA204072 | Methylprednisolone METHYLPREDNISOLONE | Tianjin Tianyao |
| May 31, 2017 | ANDA208170 | Cyclobenzaprine hydrochloride CYCLOBENZAPRINE HYDROCHLORIDE | Rubicon Research |
| January 6, 2017 | ANDA208706 | Duloxetine DULOXETINE HYDROCHLORIDE | Ajanta Pharma Ltd |
| September 13, 2016 | ANDA208301 | Diclofenac DICLOFENAC SODIUM | Glenmark Pharms Ltd |
| March 16, 2016 | ANDA204590 | Celecoxib CELECOXIB | Macleods Pharms |
| February 18, 2016 | ANDA204989 | Gabapentin RELGAABI | Sciegen Pharms |
| February 4, 2016 | ANDA205101 | Gabapentin GABAPENTIN | Sciegen Pharms |
| October 31, 2014 | ANDA091672 | Omeprazole OMEPRAZOLE | Glenmark Pharms Ltd |
| September 10, 2014 | ANDA202882 | Pantoprazole sodium PANTOPRAZOLE SODIUM | Hetero Labs Ltd V |
| December 17, 2013 | ANDA090776 | Duloxetine DULOXETINE HYDROCHLORIDE | Actavis Elizabeth |
| September 28, 2012 | ANDA202038 | Pantoprazole sodium PANTOPRAZOLE SODIUM | Aurobindo Pharma Ltd |
| December 20, 2011 | ANDA201090 | Amoxicillin and clavulanate potassium (amoxicillin / clavulanate) AMOXICILLIN AND CLAVULANATE POTASSIUM | Aurobindo Pharma Ltd |
| June 20, 2011 | ANDA201043 | Levofloxacin LEVOFLOXACIN | Aurobindo Pharma Ltd |
| December 20, 2010 | ANDA090836 | Cephalexin CEPHALEXIN | Alkem Labs Ltd |
| December 17, 2010 | ANDA090858 | Gabapentin GABAPENTIN | Alkem |
| April 12, 2010 | ANDA090469 | Ondansetron ONDANSETRON | Aurobindo Pharma |
| August 15, 2008 | ANDA077285 | Bupropion BUPROPION HYDROCHLORIDE | Watson Labs Inc |
| June 30, 2008 | ANDA077568 | Ciprofloxacin CIPROFLOXACIN HYDROCHLORIDE | Fdc Ltd |
Show the other 13 applications
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| April 26, 2007 | ANDA077859 | Ciprofloxacin CIPROFLOXACIN HYDROCHLORIDE | Aurobindo Pharma |
| March 26, 2007 | ANDA065378 | Amoxicillin AMOXICILLIN | Sandoz |
| March 26, 2007 | ANDA065387 | Amoxicillin AMOXICILLIN | Sandoz |
| March 7, 2007 | ANDA077584 | Paroxetine PAROXETINE HYDROCHLORIDE | Zydus Pharms USA |
| January 31, 2007 | NDA021234 | Diclofenac epolamine FLECTOR | Ibsa |
| December 20, 2006 | ANDA077927 | Meloxicam MELOXICAM | Unichem |
| November 9, 2005 | ANDA065271 | Amoxicillin AMOXICILLIN | Aurobindo |
| July 29, 2004 | ANDA076665 | Fluconazole FLUCONAZOLE | Chartwell |
| November 7, 2003 | ANDA065123 | Mupirocin MUPIROCIN | Padagis Israel |
| January 29, 2003 | ANDA040489 | Methocarbamol METHOCARBAMOL | Oxford Pharms |
| July 3, 2002 | ANDA076286 | Tizanidine TIZANIDINE HYDROCHLORIDE | DR Reddys Labs Inc |
| February 2, 2001 | ANDA065061 | Clindamycin CLINDAMYCIN HYDROCHLORIDE | Sun Pharm Inds Ltd |
| September 11, 1984 | ANDA062500 | Doxycycline DOXYCYCLINE HYCLATE | Chartwell |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
No recall of these products (by NDC code) appears in the FDA enforcement reports.
Next steps
- Find a pharmacy near youAsk which company made your medicine and whether it is recalled
- Latest FDA drug recallsAll companies, newest first
- All drug companiesA to Z
- All prescription drugs A to ZSearch by generic, brand or Spanish name
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026