Register entry
- Registered sites
- 0
- Active NDC listings
- 30
- Labeller names
- 2
- Live patents
- 0
- Countries
- 0
Catalogue
Drug listings by form and route
3030 active NDC listings: 28 human prescription drug, 2 human otc drug. By marketing category: ANDA 27, OTC MONOGRAPH DRUG 2, UNAPPROVED DRUG OTHER 1.
| Dosage form | NDCs |
|---|---|
| tablet, film coated | 7 |
| capsule, extended release | 6 |
| tablet | 4 |
| capsule | 3 |
| solution | 3 |
| liquid | 2 |
| gel, dentifrice | 1 |
| ointment, augmented | 1 |
| suspension | 1 |
| tablet, delayed release | 1 |
| tablet, for suspension | 1 |
| Route | NDCs |
|---|---|
| oral | 23 |
| respiratory (inhalation) | 3 |
| topical | 3 |
| dental | 1 |
| rectal | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| burel pharmaceuticals, llc | 29 |
| burel pharmaceuticals llc | 1 |
Catalogue
Marketed products
30| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| BETAMETHASONE DIPROPIONATE | BETAMETHASONE DIPROPIONATE | ointment, augmented, topical | 35573-107ANDA |
| BUTALBITAL AND ACETAMINOPHEN | butalbital and acetaminophen | tablet, oral | 35573-455ANDA |
| BUTALBITAL AND ACETAMINOPHEN | butalbital and acetaminophen | tablet, oral | 35573-456ANDA |
| Benzoyl Peroxide | Benzoyl Peroxide | liquid, topical | 35573-453OTC MONOGRAPH DRUG |
| Benzoyl Peroxide | Benzoyl Peroxide | liquid, topical | 35573-454OTC MONOGRAPH DRUG |
| Carglumic acid | Carglumic acid | tablet, for suspension, oral | 35573-459ANDA |
| Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate | capsule, extended release, oral | 35573-464ANDA |
| Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate | capsule, extended release, oral | 35573-465ANDA |
| Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate | capsule, extended release, oral | 35573-466ANDA |
| Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate | capsule, extended release, oral | 35573-467ANDA |
| Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate | capsule, extended release, oral | 35573-468ANDA |
| Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate | capsule, extended release, oral | 35573-469ANDA |
| Finasteride | Finasteride | tablet, film coated, oral | 35573-400ANDA |
| KETOCONAZOLE | ketoconazole | tablet, oral | 35573-433ANDA |
| Leflunomide | leflunomide | tablet, film coated, oral | 35573-447ANDA |
| Leflunomide | leflunomide | tablet, film coated, oral | 35573-448ANDA |
| Levalbuterol | Levalbuterol Hydrochloride | solution, respiratory (inhalation) | 35573-443ANDA |
| Levalbuterol | Levalbuterol Hydrochloride | solution, respiratory (inhalation) | 35573-444ANDA |
| Levalbuterol | Levalbuterol Hydrochloride | solution, respiratory (inhalation) | 35573-445ANDA |
| MiloPhene | Clomiphene Citrate | tablet, oral | 35573-470ANDA |
| NICARDIPINE HYDROCHLORIDE | nicardipine hydrochloride | capsule, oral | 35573-457ANDA |
| NICARDIPINE HYDROCHLORIDE | nicardipine hydrochloride | capsule, oral | 35573-458ANDA |
| PHENOXYBENZAMINE HYDROCHLORIDE | PHENOXYBENZAMINE HYDROCHLORIDE | capsule, oral | 35573-473ANDA |
| Pantoprazole Sodium | Pantoprazole Sodium | tablet, delayed release, oral | 35573-428ANDA |
| Sodium Fluoride 1.1% | Sodium Fluoride | gel, dentifrice, dental | 35573-435UNAPPROVED DRUG OTHER |
| Sodium Polystyrene Sulfonate | sodium polystyrene sulfonate | suspension, oral, rectal | 35573-108ANDA |
| tadalafil | Tadalafil | tablet, film coated, oral | 35573-460ANDA |
| tadalafil | Tadalafil | tablet, film coated, oral | 35573-461ANDA |
| tadalafil | Tadalafil | tablet, film coated, oral | 35573-462ANDA |
| tadalafil | Tadalafil | tablet, film coated, oral | 35573-463ANDA |
Compare
Other companies listing dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate
- Amneal Pharmaceuticals of New York, LLC14 sites · 227 NDC
- Elite Laboratories, Inc.1 site · 54 NDC
- Rhodes Pharmaceuticals LLC0 sites · 66 NDC
Enquiry
Common questions
- Is Burel Pharmaceuticals, LLC FDA approved?
- Burel Pharmaceuticals, LLC holds no registered establishment of its own; 30 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
- What drugs does Burel Pharmaceuticals, LLC make?
- 30 products are listed under Burel Pharmaceuticals, LLC in the openFDA NDC Directory, most often as tablet, film coated; capsule, extended release; tablet. 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.