Drug company (FDA labeler)
Burel Pharmaceuticals, LLC
NDC labeler code: 35573
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
- Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfateAdderall, Mixed Salts of a Single Entity Amphetamine Product XR, Adderall XR · 6 products
- TadalafilCialis, Tadliq, Adcirca · 4 products
- LevalbuterolXopenex HFA · 3 products
- LeflunomideArava · 2 products
- Butalbital and acetaminophenTencon, Allzital · 2 products
- NicardipineCardene IV · 2 products
- FinasteridePropecia, Proscar · 1 product
- Clomiphene citrateClomid, Milophene · 1 product
- Pantoprazole sodiumProtonix I.V., Protonix Delayed-Release, Pantoprazole Sodium I.V. · 1 product
- Phenoxybenzamine hydrochloride1 product
- Sodium polystyrene sulfonateKionex · 1 product
- KetoconazoleKetodan · 1 product
- Betamethasone dipropionateDiprolene, Sernivo · 1 product
- Carglumic acidCarbaglu · 1 product
FDA applications for these products
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| June 10, 2025 | ANDA214912 | Sodium polystyrene sulfonate SODIUM POLYSTYRENE SULFONATE | Lyne |
| April 10, 2024 | ANDA218289 | Betamethasone dipropionate BETAMETHASONE DIPROPIONATE | Aurobindo Pharma Ltd |
| July 17, 2023 | ANDA215377 | Nicardipine NICARDIPINE HYDROCHLORIDE | Pharmazone |
| May 8, 2023 | ANDA215600 | Phenoxybenzamine hydrochloride PHENOXYBENZAMINE HYDROCHLORIDE | Aurobindo Pharma |
| June 22, 2022 | ANDA213395 | Carglumic acid CARGLUMIC ACID | Navinta LLC |
| April 7, 2022 | ANDA214088 | Butalbital and acetaminophen BUTALBITAL AND ACETAMINOPHEN | Pharmazone |
| November 4, 2021 | ANDA215556 | Tadalafil TADALAFIL | Vkt Pharma |
| May 10, 2021 | ANDA213497 | Leflunomide LEFLUNOMIDE | Aet Pharma |
| December 11, 2019 | ANDA212037 | Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | Elite Labs Inc |
| March 22, 2016 | ANDA203653 | Levalbuterol LEVALBUTEROL HYDROCHLORIDE | Ritedose Corp |
| November 5, 2013 | ANDA203687 | Finasteride FINASTERIDE | Aurobindo Pharma Ltd |
| September 28, 2012 | ANDA202038 | Pantoprazole sodium PANTOPRAZOLE SODIUM | Aurobindo Pharma Ltd |
| January 10, 2002 | ANDA075912 | Ketoconazole KETOCONAZOLE | Pharmazone |
| December 20, 1988 | ANDA072196 | Clomiphene citrate MILOPHENE | Granata Bio Corp |
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