Register entryRepackager / relabeller
- Registered sites
- 1
- Active NDC listings
- 110
- Labeller names
- 6
- Live patents
- 0
- Countries
- 1
- Base
- United States
Authorisation
Registered operations
Labelling1Packaging1Relabelling1Repackaging1
Sites
Registered establishments
1| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Marlex Pharmaceuticals, Inc | 65 Lukens Drive, New Castle, Delaware (DE) 19720, United States (USA) | Labelling, Packaging, Relabelling, Repackaging | 1000121454782540215 |
Catalogue
Drug listings by form and route
110110 active NDC listings: 95 human prescription drug, 15 human otc drug. By marketing category: ANDA 90, OTC MONOGRAPH DRUG 13, NDA 5, UNAPPROVED DRUG OTHER 2.
| Dosage form | NDCs |
|---|---|
| tablet | 55 |
| tablet, film coated | 29 |
| capsule | 5 |
| solution | 4 |
| tablet, extended release | 4 |
| capsule, extended release | 3 |
| cream | 2 |
| capsule, gelatin coated | 1 |
| elixir | 1 |
| injection, solution | 1 |
| ointment | 1 |
| powder | 1 |
| powder, for solution | 1 |
| suppository | 1 |
| suspension | 1 |
| Route | NDCs |
|---|---|
| oral | 102 |
| topical | 6 |
| intravenous | 1 |
| rectal | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| marlex pharmaceuticals, inc. | 65 |
| marlex pharmaceuticals inc | 30 |
| marlex pharmaceuticals, inc | 7 |
| marlex pharmaceutical, inc | 3 |
| marlex pharmaceuticals, inc | 3 |
| marlex pharmaceuticals inc. | 2 |
Catalogue
Marketed products
110| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| ATENOLOL AND CHLORTHALIDONE | atenolol and chlorthalidone tablet | tablet, oral | 10135-733ANDA |
| ATENOLOL AND CHLORTHALIDONE | atenolol and chlorthalidone tablet | tablet, oral | 10135-734ANDA |
| Acetaminophen | Acetaminophen | tablet, oral | 10135-829OTC MONOGRAPH DRUG |
| Acetaminophen 325mg | Acetaminophen | tablet, oral | 10135-828OTC MONOGRAPH DRUG |
| Acetazolamide | Acetazolamide | tablet, oral | 10135-830ANDA |
| Acetazolamide | Acetazolamide | tablet, oral | 10135-831ANDA |
| Alendronate | Alendronate sodium tablet | tablet, oral | 10135-718ANDA |
| Alendronate | Alendronate sodium tablet | tablet, oral | 10135-719ANDA |
| Amantadine Hydrochloride | Amantadine Hydrochloride | tablet, oral | 10135-692ANDA |
| Amantadine Hydrochloride | Amantadine Hydrochloride | capsule, gelatin coated, oral | 10135-693ANDA |
| Aspirin | Aspirin | tablet, oral | 10135-729OTC MONOGRAPH DRUG |
| BENZTROPINE MESYLATE | benztropine mesylate | tablet, oral | 10135-813ANDA |
| BENZTROPINE MESYLATE | benztropine mesylate | tablet, oral | 10135-814ANDA |
| BENZTROPINE MESYLATE | benztropine mesylate | tablet, oral | 10135-815ANDA |
| Baclofen | baclofen | tablet, oral | 10135-532ANDA |
| Baclofen | baclofen | tablet, oral | 10135-533ANDA |
| Bisoprolol Fumarate and Hydrochlorothiazide | Bisoprolol Fumarate and Hydrochlorothiazide | tablet, oral | 10135-740ANDA |
| Bisoprolol Fumarate and Hydrochlorothiazide | Bisoprolol Fumarate and Hydrochlorothiazide | tablet, oral | 10135-741ANDA |
| Bisoprolol Fumarate and Hydrochlorothiazide | Bisoprolol Fumarate and Hydrochlorothiazide | tablet, oral | 10135-742ANDA |
| Cetirizine Hydrochloride | Cetirizine Hydrochloride | tablet, oral | 10135-762ANDA |
| Clotrimazole | Clotrimazole | solution, topical | 10135-671OTC MONOGRAPH DRUG |
| Desvenlafaxine | Desvenlafaxine | tablet, extended release, oral | 10135-821ANDA |
| Desvenlafaxine | Desvenlafaxine | tablet, extended release, oral | 10135-822ANDA |
| Dexamethasone | Dexamethasone | elixir, oral | 10135-795ANDA |
| Diclofenac Potassium | diclofenac potassium | tablet, film coated, oral | 10135-806ANDA |
| Digoxin | Digoxin | tablet, oral | 10135-747ANDA |
| Digoxin | Digoxin | tablet, oral | 10135-748ANDA |
| Doxepin | Doxepin | tablet, film coated, oral | 10135-758ANDA |
| Doxepin | Doxepin | tablet, film coated, oral | 10135-764ANDA |
| ETHAMBUTOL HYDROCHLORIDE | ETHAMBUTOL HYDROCHLORIDE | tablet, film coated, oral | 10135-796NDA |
| ETHAMBUTOL HYDROCHLORIDE | ETHAMBUTOL HYDROCHLORIDE | tablet, film coated, oral | 10135-797NDA |
| Ezetimibe | Ezetimibe | tablet, oral | 10135-787ANDA |
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | tablet, oral | 10135-725ANDA |
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | tablet, oral | 10135-726ANDA |
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | tablet, oral | 10135-727ANDA |
| FLUPHENAZINE HYDROCHLORIDE | FLUPHENAZINE HYDROCHLORIDE | tablet, oral | 10135-728ANDA |
| Furosemide | FUROSEMIDE | tablet, oral | 10135-832NDA |
| Furosemide | FUROSEMIDE | tablet, oral | 10135-833NDA |
| Furosemide | FUROSEMIDE | tablet, oral | 10135-834NDA |
| Guaifenesin 200mg | Guaifenesin | tablet, oral | 10135-789OTC MONOGRAPH DRUG |
| Guaifenesin 400mg | Guaifenesin | tablet, oral | 10135-790OTC MONOGRAPH DRUG |
| HYDROXYZINE HYDROCHLORIDE | hydroxyzine hydrochloride | tablet, film coated, oral | 10135-810ANDA |
| HYDROXYZINE HYDROCHLORIDE | hydroxyzine hydrochloride | tablet, film coated, oral | 10135-811ANDA |
| HYDROXYZINE HYDROCHLORIDE | hydroxyzine hydrochloride | tablet, film coated, oral | 10135-812ANDA |
| Haloperidol | Haloperidol | tablet, oral | 10135-752ANDA |
| Haloperidol | Haloperidol | tablet, oral | 10135-753ANDA |
| Haloperidol | Haloperidol | tablet, oral | 10135-754ANDA |
| Haloperidol | Haloperidol | tablet, oral | 10135-755ANDA |
| Haloperidol | Haloperidol | tablet, oral | 10135-756ANDA |
| Haloperidol | Haloperidol | tablet, oral | 10135-757ANDA |
| Hydrocortisone Acetate | Hydrocortisone Acetate | suppository, rectal | 10135-751UNAPPROVED DRUG OTHER |
| Labetalol Hydrochloride | Labetalol | tablet, film coated, oral | 10135-711ANDA |
| Labetalol Hydrochloride | Labetalol | tablet, film coated, oral | 10135-712ANDA |
| Labetalol Hydrochloride | Labetalol | tablet, film coated, oral | 10135-713ANDA |
| Lacosamide | Lacosamide | tablet, film coated, oral | 10135-799ANDA |
| Lacosamide | Lacosamide | tablet, film coated, oral | 10135-800ANDA |
| Lacosamide | Lacosamide | tablet, film coated, oral | 10135-801ANDA |
| Lacosamide | Lacosamide | tablet, film coated, oral | 10135-802ANDA |
| Levocetirizine Dihydrochloride | levocetirizine Dihydrochloride | tablet, film coated, oral | 10135-639ANDA |
| Lidocaine | Lidocaine | cream, topical | 10135-672OTC MONOGRAPH DRUG |
| Lidocaine Hydrochloride | Lidocaine Hydrochloride | solution, topical | 10135-736ANDA |
| Loratadine Allergy Relief | Loratadine | tablet, oral | 10135-763ANDA |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | tablet, extended release, oral | 10135-823ANDA |
| METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE | tablet, extended release, oral | 10135-824ANDA |
| METOLAZONE | metolazone | tablet, oral | 10135-765ANDA |
| METOLAZONE | metolazone | tablet, oral | 10135-766ANDA |
| METOLAZONE | metolazone | tablet, oral | 10135-767ANDA |
| Magnesium Oxide | Magnesium Oxide | tablet, oral | 10135-786OTC MONOGRAPH DRUG |
| Menthol and Zinc Oxide | Menthol and Zinc Oxide | ointment, topical | 10135-701OTC MONOGRAPH DRUG |
| Methocarbamol Tablets, USP, 500 mg | Methocarbamol | tablet, film coated, oral | 10135-722ANDA |
| Methocarbamol Tablets, USP, 750 mg | Methocarbamol | tablet, film coated, oral | 10135-723ANDA |
| Miconazole Nitrate Antifungal Powder | Miconazole Nitrate Antifungal Powder | powder, topical | 10135-720OTC MONOGRAPH DRUG |
| Oxcarbazepine | Oxcarbazepine | suspension, oral | 10135-798ANDA |
| PYRAZINAMIDE | pyrazinamide tablet | tablet, oral | 10135-735ANDA |
| Pindolol | Pindolol | tablet, oral | 10135-743ANDA |
| Pindolol | Pindolol | tablet, oral | 10135-744ANDA |
| Potassium Chloride for Oral Solution | Potassium Chloride for Oral Solution | powder, for solution, oral | 10135-807ANDA |
| Potassium Chloride for Oral Solution | Potassium Chloride for Oral Solution | solution, oral | 10135-819ANDA |
| Potassium Chloride for Oral Solution | Potassium Chloride for Oral Solution | solution, oral | 10135-820ANDA |
| Prazosin Hydrochloride | Prazosin Hydrochloride | capsule, oral | 10135-666ANDA |
| Prazosin Hydrochloride | Prazosin Hydrochloride | capsule, oral | 10135-667ANDA |
| Prazosin Hydrochloride | Prazosin Hydrochloride | capsule, oral | 10135-668ANDA |
| Prednisone | Prednisone | tablet, oral | 10135-775ANDA |
| Prednisone | Prednisone | tablet, oral | 10135-776ANDA |
| Prednisone | Prednisone | tablet, oral | 10135-777ANDA |
| Prednisone | Prednisone | tablet, oral | 10135-778ANDA |
| Prednisone | Prednisone | tablet, oral | 10135-779ANDA |
| Probenecid | Probenecid | tablet, film coated, oral | 10135-541ANDA |
| Ramelteon | Ramelteon | tablet, film coated, oral | 10135-838ANDA |
| Regadenoson | Regadenoson | injection, solution, intravenous | 10135-803ANDA |
| Rifabutin | Rifabutin | capsule, oral | 10135-738ANDA |
| Ropinirole | ropinirole | tablet, film coated, oral | 10135-673ANDA |
| Ropinirole | ropinirole | tablet, film coated, oral | 10135-674ANDA |
| Ropinirole | ropinirole | tablet, film coated, oral | 10135-675ANDA |
| Ropinirole | ropinirole | tablet, film coated, oral | 10135-676ANDA |
| Ropinirole | ropinirole | tablet, film coated, oral | 10135-677ANDA |
| Ropinirole | ropinirole | tablet, film coated, oral | 10135-678ANDA |
| Ropinirole | ropinirole | tablet, film coated, oral | 10135-679ANDA |
| Selegiline Hydrochloride | Selegiline Hydrochloride | capsule, oral | 10135-737ANDA |
| Senna S | Docusate Sodium and Sennosides | tablet, oral | 10135-669OTC MONOGRAPH DRUG |
| Sennosides | Sennosides | tablet, oral | 10135-314OTC MONOGRAPH DRUG |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | capsule, extended release, oral | 10135-825ANDA |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | capsule, extended release, oral | 10135-826ANDA |
| VENLAFAXINE HYDROCHLORIDE | VENLAFAXINE HYDROCHLORIDE | capsule, extended release, oral | 10135-827ANDA |
| Varenicline | Varenicline tartrate | tablet, film coated, oral | 10135-808ANDA |
| Varenicline | Varenicline tartrate | tablet, film coated, oral | 10135-809ANDA |
| hydroquinone | hydroquinone | cream, topical | 10135-724UNAPPROVED DRUG OTHER |
| isoniazid | isoniazid | tablet, oral | 10135-804ANDA |
| isoniazid | isoniazid | tablet, oral | 10135-805ANDA |
| magnesium oxide | magnesium oxide | tablet, oral | 10135-721OTC MONOGRAPH DRUG |
Neighbours
Registered in the same town
4- CAD IMPORT, INC.New Castle, DE
- The Hibbert CompanyNew Castle, DE
- Keen Compressed Gas Company, Inc.New Castle, DE
- Pharmadel LLCNew Castle, DE
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Enquiry
Common questions
- Is Marlex Pharmaceuticals, Inc FDA approved?
- Marlex Pharmaceuticals, 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 Marlex Pharmaceuticals, Inc's registered sites?
- The FDA register lists New Castle, DE. Registered operations: labelling, packaging, relabelling, repackaging.
- What drugs does Marlex Pharmaceuticals, Inc make?
- 110 products are listed under Marlex Pharmaceuticals, Inc in the openFDA NDC Directory, most often as tablet; tablet, film coated; 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.