Data / Drug companies / Burel Pharmaceuticals, LLC
Burel Pharmaceuticals, LLC: 30 products in the FDA NDC directory, labeler code 35573
Burel Pharmaceuticals, LLC (labeler code 35573) lists 30 products in the FDA National Drug Code Directory, covering 15 finished drugs by generic name. By type: 28 prescription drugs, 2 over the counter drugs. Its main marketing category is generic drugs (ANDA). The newest product started marketing on December 18, 2025.
SpecStream is the live web data engine for teams and agents. It reads the National Drug Code Directory that FDA publishes, and this page is that reading. Ask for the companies that make a drug, a class or a dosage form, with their headquarters, website and size added from the web, and new listings and discontinued products arrive in your sheet, CRM, Slack or agent as FDA posts them.
- Labeler code
- 35573
- Products in commercial distribution
- 30
- Packages
- 36
- Finished drugs by generic name
- 15
- Prescription products
- 28
- Over the counter products
- 2
- Controlled substance products
- Schedule II 6, Schedule III 2
- Flagged as original packager
- 30 of 30 products that carry the flag
- Started marketing in the last 12 months
- 1
- Products with a marketing end date set
- 6
- Earliest marketing start
- July 13, 2018
- openFDA record search
- api.fda.gov
Products by marketing category
Share of the company's products in commercial distribution.
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 27 | 90% |
| Over the counter monograph drugs | 2 | 6.7% |
| Other unapproved drugs | 1 | 3.3% |
Products by type
| Type | Products | Share |
|---|---|---|
| Prescription drugs | 28 | 93.3% |
| Over the counter drugs | 2 | 6.7% |
Drugs it lists
Finished drugs by generic name, with how many companies list each.
| Drug | Products | Companies listing it |
|---|---|---|
| Tadalafil | 4 | 54 |
| Levalbuterol hydrochloride | 3 | 6 |
| Leflunomide | 2 | 19 |
| Benzoyl peroxide | 2 | 82 |
| Butalbital and acetaminophen | 2 | 9 |
| Nicardipine hydrochloride | 2 | 27 |
| Sodium polystyrene sulfonate | 1 | 13 |
| Clomiphene citrate | 1 | 8 |
| Pantoprazole sodium | 1 | 54 |
| Ketoconazole | 1 | 35 |
| Betamethasone dipropionate | 1 | 27 |
| Finasteride | 1 | 31 |
| Carglumic acid | 1 | 4 |
| Sodium fluoride | 1 | 124 |
| Phenoxybenzamine hydrochloride | 1 | 5 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet, film coated | 7 | 23.3% |
| Capsule, extended release | 6 | 20% |
| Tablet | 4 | 13.3% |
| Solution | 3 | 10% |
| Capsule | 3 | 10% |
| Liquid | 2 | 6.7% |
| Suspension | 1 | 3.3% |
| Tablet, delayed release | 1 | 3.3% |
| Ointment, augmented | 1 | 3.3% |
| Tablet, for suspension | 1 | 3.3% |
| Gel, dentifrice | 1 | 3.3% |
Pharmacologic classes
FDA established pharmacologic classes of its products.
Newest products
By marketing start date.
| Product | Product NDC | Dosage form | Marketing category | Marketing start |
|---|---|---|---|---|
| Sodium Polystyrene Sulfonate | 35573-108 | Suspension | Generic drugs (ANDA) | December 18, 2025 |
| MiloPhene | 35573-470 | Tablet | Generic drugs (ANDA) | August 15, 2025 |
| Betamethasone dipropionate | 35573-107 | Ointment, augmented | Generic drugs (ANDA) | January 15, 2025 |
| Phenoxybenzamine hydrochloride | 35573-473 | Capsule | Generic drugs (ANDA) | May 8, 2023 |
| Tadalafil | 35573-463 | Tablet, film coated | Generic drugs (ANDA) | April 1, 2023 |
| Tadalafil | 35573-462 | Tablet, film coated | Generic drugs (ANDA) | April 1, 2023 |
| Tadalafil | 35573-461 | Tablet, film coated | Generic drugs (ANDA) | April 1, 2023 |
| Tadalafil | 35573-460 | Tablet, film coated | Generic drugs (ANDA) | April 1, 2023 |
| Nicardipine hydrochloride | 35573-458 | Capsule | Generic drugs (ANDA) | January 8, 2023 |
| Nicardipine hydrochloride | 35573-457 | Capsule | Generic drugs (ANDA) | January 8, 2023 |
| Carglumic acid | 35573-459 | Tablet, for suspension | Generic drugs (ANDA) | December 19, 2022 |
| Butalbital and acetaminophen | 35573-456 | Tablet | Generic drugs (ANDA) | December 1, 2022 |
| Butalbital and acetaminophen | 35573-455 | Tablet | Generic drugs (ANDA) | December 1, 2022 |
| Benzoyl Peroxide | 35573-454 | Liquid | Over the counter monograph drugs | April 15, 2022 |
| Benzoyl Peroxide | 35573-453 | Liquid | Over the counter monograph drugs | April 15, 2022 |
| Leflunomide | 35573-448 | Tablet, film coated | Generic drugs (ANDA) | January 3, 2022 |
| Leflunomide | 35573-447 | Tablet, film coated | Generic drugs (ANDA) | January 3, 2022 |
| Levalbuterol | 35573-445 | Solution | Generic drugs (ANDA) | April 1, 2021 |
| Levalbuterol | 35573-444 | Solution | Generic drugs (ANDA) | April 1, 2021 |
| Levalbuterol | 35573-443 | Solution | Generic drugs (ANDA) | April 1, 2021 |
| Pantoprazole Sodium | 35573-428 | Tablet, delayed release | Generic drugs (ANDA) | April 20, 2020 |
| Ketoconazole | 35573-433 | Tablet | Generic drugs (ANDA) | April 10, 2020 |
| Sodium Fluoride 1.1% | 35573-435 | Gel, dentifrice | Other unapproved drugs | February 28, 2020 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate | 35573-469 | Capsule, extended release | Generic drugs (ANDA) | December 16, 2019 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate | 35573-468 | Capsule, extended release | Generic drugs (ANDA) | December 16, 2019 |
Updated November 6, 2026. Read from US Food and Drug Administration, National Drug Code Directory (openFDA). CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.