Register entryShortage reported
- Registered sites
- 5
- Active NDC listings
- 70
- Live patents
- 45
- Shortage listings
- 2
- Countries
- 1
- Base
- United States
Authorisation
Registered operations
Analytical testing2Labelling2Finished drug manufacture4Packaging2Repackaging1
Sites
Registered establishments
5| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| American Regent, Inc. | 592 Apollo Street, Brea, California (CA) 92821, United States (USA) | Finished drug manufacture, Repackaging | 3011148804117181770 |
| American Regent, Inc. | 960 Crupper Avenue, Columbus, Ohio (OH) 43229, United States (USA) | Analytical testing | 3003433784116981917 |
| American Regent, Inc. | 4150 Lyman Drive, Hilliard, Ohio (OH) 43026, United States (USA) | Finished drug manufacture | 3005761472606821721 |
| American Regent, Inc. | 6610 New Albany Road East, New Albany, Ohio (OH) 43054, United States (USA) | Labelling, Finished drug manufacture, Packaging | 3010209784027223179 |
| American Regent, Inc. | 5 Ramsey Road, Shirley, New York (NY) 11967, United States (USA) | Analytical testing, Labelling, Finished drug manufacture, Packaging | 2410375002033710 |
Alert
Drug shortage listings
2| Drug | Presentation | Status | Availability | Posted / updated |
|---|---|---|---|---|
| Atropine Sulfate InjectionAnesthesia, Neurology, Pediatric | Atropine Sulfate, Injection, 1 mg/1 mL (NDC 0517-1001-25) | Current | Available | 1 Jan 20121 Oct 2026 |
| Atropine Sulfate InjectionAnesthesia, Neurology, Pediatric | Atropine Sulfate, Injection, .4 mg/1 mL (NDC 0517-1004-25) | Current | Available | 1 Jan 20121 Oct 2026 |
Catalogue
Drug listings by form and route
7070 active NDC listings: 70 human prescription drug. By marketing category: ANDA 43, NDA 21, UNAPPROVED DRUG OTHER 6.
| Dosage form | NDCs |
|---|---|
| injection, solution | 54 |
| injection | 5 |
| inhalant | 4 |
| injection, suspension | 3 |
| injection, powder, lyophilized, for solution | 2 |
| injection, powder, lyophilized, for suspension | 1 |
| injection, solution, concentrate | 1 |
| Route | NDCs |
|---|---|
| intravenous | 52 |
| intramuscular | 23 |
| subcutaneous | 5 |
| respiratory (inhalation) | 4 |
| intra-articular | 3 |
| intralesional | 3 |
| Labeller name on the listing | NDCs |
|---|---|
| american regent, inc. | 70 |
Exclusivity
Patents and exclusivities
45| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 11364260 | INJECTAFERferric carboxymaltose | use | Jan 2027 |
| 11433091 | INJECTAFERferric carboxymaltose | use | Jan 2027 |
| 11478502 | INJECTAFERferric carboxymaltose | use | Jan 2027 |
| 8895612 | INJECTAFERferric carboxymaltose | use | Jan 2027 |
| 7612109 | INJECTAFERferric carboxymaltose | substance, product | Feb 2027 |
| 7754702 | INJECTAFERferric carboxymaltose | use | Feb 2028 |
| 11786548 | MULTRYS, TRALEMENTcupric sulfate; manganese sulfate; selenious acid; zinc sulfate | product | Jul 2041 |
| 11975022 | MULTRYS, TRALEMENTcupric sulfate; manganese sulfate; selenious acid; zinc sulfate | use | Jul 2041 |
| 11998565 | MULTRYS, SELENIOUS ACID, TRALEMENTcupric sulfate; manganese sulfate; selenious acid; zinc sulfate; selenious acid | product | Jul 2041 |
| 12150956 | MULTRYS, TRALEMENTcupric sulfate; manganese sulfate; selenious acid; zinc sulfate | use | Jul 2041 |
| 12150957 | MULTRYS, SELENIOUS ACID, TRALEMENTcupric sulfate; manganese sulfate; selenious acid; zinc sulfate; selenious acid | use | Jul 2041 |
Catalogue
Marketed products
70| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| Acetylcysteine | acetylcysteine | inhalant, respiratory (inhalation) | 0517-7504ANDA |
| Acetylcysteine | acetylcysteine | inhalant, respiratory (inhalation) | 0517-7510ANDA |
| Acetylcysteine | acetylcysteine | inhalant, respiratory (inhalation) | 0517-7604ANDA |
| Acetylcysteine | acetylcysteine | inhalant, respiratory (inhalation) | 0517-7610ANDA |
| Aminocaproic Acid | Aminocaproic Acid | injection, solution, intravenous | 0517-9120ANDA |
| Aminocaproic Acid | Aminocaproic Acid | injection, solution, intravenous | 0517-9191ANDA |
| Atropine Sulfate | ATROPINE SULFATE | injection, solution, intravenous | 0517-1001ANDA |
| Atropine Sulfate | ATROPINE SULFATE | injection, solution, intravenous | 0517-1004ANDA |
| Betamethasone Sodium Phosphate and Betamethasone Acetate | Betamethasone Sodium Phosphate and Betamethasone Acetate | injection, suspension, intra-articular, intralesional, intramuscular | 0517-0720ANDA |
| Betamethasone Sodium Phosphate and Betamethasone Acetate | Betamethasone Sodium Phosphate and Betamethasone Acetate | injection, suspension, intra-articular, intralesional, intramuscular | 0517-0791ANDA |
| Betamethasone Sodium Phosphate and Betamethasone Acetate | Betamethasone Sodium Phosphate and Betamethasone Acetate | injection, suspension, intra-articular, intralesional, intramuscular | 0517-0799ANDA |
| Caffeine and Sodium Benzoate | Caffeine and Sodium Benzoate | injection, solution, intramuscular, intravenous | 0517-2502UNAPPROVED DRUG OTHER |
| Calcium Chloride | CALCIUM CHLORIDE | injection, solution, intravenous | 0517-6710ANDA |
| Chlorothiazide Sodium | Chlorothiazide Sodium | injection, powder, lyophilized, for solution, intravenous | 0517-1820ANDA |
| Cyanocobalamin | cyanocobalamin | injection, solution, intramuscular, subcutaneous | 0517-0031ANDA |
| Cyanocobalamin | cyanocobalamin | injection, solution, intramuscular, subcutaneous | 0517-0032ANDA |
| Cyanocobalamin | cyanocobalamin | injection, solution, intramuscular, subcutaneous | 0517-0130ANDA |
| Dicyclomine hydrochloride | Dicyclomine hydrochloride | injection, solution, intramuscular | 0517-1980ANDA |
| Droperidol | Droperidol | injection, solution, intramuscular, intravenous | 0517-9702ANDA |
| ESTRADIOL VALERATE | ESTRADIOL VALERATE | injection, solution, intramuscular | 0517-0420ANDA |
| ESTRADIOL VALERATE | ESTRADIOL VALERATE | injection, solution, intramuscular | 0517-0440ANDA |
| Epinephrine | epinephrine | injection, intramuscular, intravenous, subcutaneous | 0517-3030ANDA |
| Glycopyrrolate | Glycopyrrolate | injection, solution, intramuscular, intravenous | 0517-4601ANDA |
| Glycopyrrolate | Glycopyrrolate | injection, solution, intramuscular, intravenous | 0517-4602ANDA |
| Glycopyrrolate | Glycopyrrolate | injection, solution, intramuscular, intravenous | 0517-4605ANDA |
| Glycopyrrolate | Glycopyrrolate | injection, solution, intramuscular, intravenous | 0517-4620ANDA |
| Gvoke VialDx | glucagon injection | injection, solution, intravenous | 0517-2901NDA |
| Hydralazine Hydrochloride | Hydralazine Hydrochloride | injection, solution, intramuscular, intravenous | 0517-0901ANDA |
| Hydroxyzine Hydrochloride | Hydroxyzine Hydrochloride | injection, solution, intramuscular | 0517-4201ANDA |
| Hydroxyzine Hydrochloride | Hydroxyzine Hydrochloride | injection, solution, intramuscular | 0517-5601ANDA |
| Hydroxyzine Hydrochloride | Hydroxyzine Hydrochloride | injection, solution, intramuscular | 0517-5602ANDA |
| Injectafer | Ferric Carboxymaltose Injection | injection, solution, intravenous | 0517-0602NDA |
| Injectafer | Ferric Carboxymaltose | injection, solution, intravenous | 0517-0620NDA |
| Injectafer | Ferric Carboxymaltose Injection | injection, solution, intravenous | 0517-0650NDA |
| Levocarnitine | Levocarnitine | injection, solution, intravenous | 0517-1045ANDA |
| Levocarnitine | Levocarnitine | injection, solution, intravenous | 0517-1075ANDA |
| Methylergonovine Maleate | Methylergonovine Maleate | injection, solution, intramuscular, intravenous | 0517-0740ANDA |
| Multitrace -4 Pediatric | Trace Elements 4 | injection, solution, concentrate, intravenous | 0517-9203UNAPPROVED DRUG OTHER |
| Multitrace-5 | Trace Elements 5 | injection, solution, intravenous | 0517-8510UNAPPROVED DRUG OTHER |
| Multrys | Trace Elements Injection 4 | injection, solution, intravenous | 0517-9302NDA |
| Nicardipine Hydrochloride | nicardipine hydrochloride | injection, solution, intravenous | 0517-0735ANDA |
| Nitroglycerin | nitroglycerin | injection, solution, intravenous | 0517-4810ANDA |
| Olanzapine | Olanzapine | injection, powder, lyophilized, for solution, intramuscular | 0517-0955ANDA |
| PACLITAXEL PROTEIN BOUND PARTICLES ALBUMIN BOUND | Paclitaxel | injection, powder, lyophilized, for suspension, intravenous | 0517-4300NDA |
| PROVAYBLUE | methylene blue | injection, intravenous | 0517-0125NDA |
| PROVAYBLUE | methylene blue | injection, intravenous | 0517-0371NDA |
| PROVAYBLUE | methylene blue | injection, intravenous | 0517-0374NDA |
| PROVAYBLUE | methylene blue | injection, intravenous | 0517-0381NDA |
| Papaverine Hydrochloride | Papaverine Hydrochloride | injection, solution, intravenous | 0517-4002UNAPPROVED DRUG OTHER |
| Potassium Phosphates | potassium phosphates | injection, solution, intravenous | 0517-2051ANDA |
| Potassium Phosphates | Potassium Phosphate | injection, solution, intravenous | 0517-2102ANDA |
| Potassium Phosphates | Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic | injection, solution, intravenous | 0517-2505ANDA |
| Selenious Acid | Selenious Acid | injection, solution, intravenous | 0517-6502NDA |
| Selenious Acid | Selenious Acid | injection, solution, intravenous | 0517-6560NDA |
| Sodium Phosphates | sodium phosphate, monobasic, monohydrate and sodium phosphate, dibasic anhydrous | injection, solution, intravenous | 0517-7305ANDA |
| Sodium Phosphates | sodium phosphate, monobasic, monohydrate and sodium phosphate, dibasic anhydrous | injection, solution, intravenous | 0517-7315ANDA |
| Sodium Phosphates | sodium phosphate, monobasic, monohydrate and sodium phosphate, dibasic anhydrous | injection, solution, intravenous | 0517-7350ANDA |
| Sterile Water | Water | injection, solution, intravenous | 0517-3010UNAPPROVED DRUG OTHER |
| Sterile Water | Water | injection, solution, intravenous | 0517-3020UNAPPROVED DRUG OTHER |
| Tralement | Trace Elements Injection 4 | injection, solution, intravenous | 0517-9305NDA |
| Vasopressin | Vasopressin | injection, solution, intravenous | 0517-1020NDA |
| Vasopressin | Vasopressin | injection, solution, intravenous | 0517-1030NDA |
| Venofer | iron sucrose | injection, solution, intravenous | 0517-2310NDA |
| Venofer | iron sucrose | injection, solution, intravenous | 0517-2325NDA |
| Venofer | iron sucrose | injection, solution, intravenous | 0517-2340NDA |
| Zinc Sulfate | Zinc Sulfate | injection, solution, intravenous | 0517-6101NDA |
| Zinc Sulfate | Zinc Sulfate | injection, solution, intravenous | 0517-6103NDA |
| Zinc Sulfate | Zinc Sulfate | injection, solution, intravenous | 0517-8005NDA |
| epinephrine | epinephrine | injection, solution, intramuscular, subcutaneous | 0517-1171ANDA |
| fomepizole | fomepizole | injection, solution, intravenous | 0517-0710ANDA |
Neighbours
Registered in the same town
12- Cardinal Health 418, Inc.Columbus, OH
- Medical-technical Gases, Inc.HILLIARD, OH
- Amgen, IncNew Albany, OH
- Hikma Pharmaceuticals USA Inc.Columbus, OH
- Safecor Health, LLCColumbus, OH
- AmerisourceBergen Drug CorporationColumbus, OH
- Geer Gas CorporationColumbus, OH
- ISP Chemicals LLCColumbus, OH
- Tri Tech Laboratories LLCNew Albany, OH
- Vista Packaging and LogisticsColumbus, OH
- Clinical Resolution Laboratory, Inc.Brea, CA
- Slate Run Pharmaceuticals, LLCColumbus, OH
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Enquiry
Common questions
- Is American Regent, Inc. FDA approved?
- American Regent, Inc. holds 5 FDA-registered establishments 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 American Regent, Inc.'s drugs manufactured?
- The FDA register lists Brea, CA; Columbus, OH; Hilliard, OH; New Albany, OH; Shirley, NY. Registered operations: analytical testing, labelling, finished drug manufacture, packaging, repackaging.
- What drugs does American Regent, Inc. make?
- 70 products are listed under American Regent, Inc. in the openFDA NDC Directory, most often as injection, solution; injection; inhalant. The full breakdown by dosage form and route is above. A listing count is not a sales figure.
- Are any American Regent, Inc. products in shortage?
- 2 presentations are currently listed in the FDA drug shortage database under American Regent, Inc., covering Atropine Sulfate Injection.
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.