Data / Drug companies / Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc.: 65 products in the FDA NDC directory, labeler code 0597
Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).
Boehringer Ingelheim Pharmaceuticals, Inc. (labeler code 0597) lists 65 products in the FDA National Drug Code Directory, covering 23 finished drugs by generic name. By type: 65 prescription drugs. Its main marketing category is new drug applications (NDA). The newest product started marketing on October 7, 2025.
The request: Watch Boehringer Ingelheim Pharmaceuticals, Inc. (FDA labeler code 0597): each new product listing and each discontinued product. $10 of work on sign-up, no card.
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- Labeler code
- 0597
- Products in commercial distribution
- 65
- Packages
- 111
- Finished drugs by generic name
- 23
- Prescription products
- 65
- Over the counter products
- 0
- Flagged as original packager
- 65 of 65 products that carry the flag
- Started marketing in the last 12 months
- 0
- Products with a marketing end date set
- 3
- Earliest marketing start
- December 1, 2000
- openFDA record search
- api.fda.gov
Products by marketing category
Share of the company's products in commercial distribution.
| Marketing category | Products | Share |
|---|---|---|
| New drug applications (NDA) | 49 | 75.4% |
| Biologics (BLA) | 16 | 24.6% |
Products by type
| Type | Products | Share |
|---|---|---|
| Prescription drugs | 65 | 100% |
Drugs it lists
Finished drugs by generic name, with how many companies list each.
| Drug | Products | Companies listing it |
|---|---|---|
| Adalimumab-adbm | 12 | 2 |
| Dabigatran etexilate | 6 | 17 |
| Linagliptin and metformin hydrochloride | 5 | 2 |
| Empagliflozin and metformin hydrochloride | 4 | 1 |
| Empagliflozin, metformin hydrochloride | 4 | 1 |
| Empagliflozin, linagliptin, metformin hydrochloride | 4 | 1 |
| Afatinib | 3 | 2 |
| Dabigatran etexilate mesylate | 3 | 1 |
| Spesolimab-sbzo | 3 | 1 |
| Telmisartan and hydrochlorothiazide | 3 | 9 |
| Tiotropium bromide inhalation spray | 2 | 1 |
| Nerandomilast | 2 | 1 |
| Empagliflozin | 2 | 5 |
| Empagliflozin and linagliptin | 2 | 1 |
| Nintedanib | 2 | 11 |
| Idarucizumab | 1 | 1 |
| Tiotropium bromide | 1 | 3 |
| Olodaterol respimat inhalation spray | 1 | 1 |
| Tiotropium bromide and olodaterol | 1 | 1 |
| Zongertinib | 1 | 1 |
| Ipratropium bromide and albuterol | 1 | 1 |
| Linagliptin | 1 | 3 |
| Ipratropium bromide | 1 | 23 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet, film coated | 14 | 21.5% |
| Kit | 12 | 18.5% |
| Tablet, extended release | 8 | 12.3% |
| Tablet | 7 | 10.8% |
| Capsule | 6 | 9.2% |
| Pellet | 6 | 9.2% |
| Spray, metered | 5 | 7.7% |
| Injection | 4 | 6.2% |
| Tablet, film coated, extended release | 2 | 3.1% |
| Aerosol, metered | 1 | 1.5% |
Pharmacologic classes
FDA established pharmacologic classes of its products.
| Class | Products |
|---|---|
| Biguanide | 17 |
| Sodium-Glucose Cotransporter 2 Inhibitor | 16 |
| Dipeptidyl Peptidase 4 Inhibitor | 12 |
| Direct Thrombin Inhibitor | 9 |
| Kinase Inhibitor | 6 |
| Anticholinergic | 6 |
| beta2-Adrenergic Agonist | 3 |
| Interleukin-36 Receptor Antagonist | 3 |
| Angiotensin 2 Receptor Blocker | 3 |
| Thiazide Diuretic | 3 |
| Humanized Monoclonal Antibody Fragment | 1 |
Newest products
By marketing start date.
| Product | Product NDC | Dosage form | Marketing category | Marketing start |
|---|---|---|---|---|
| Jascayd | 0597-7313 | Tablet, film coated | New drug applications (NDA) | October 7, 2025 |
| Jascayd | 0597-2465 | Tablet, film coated | New drug applications (NDA) | October 7, 2025 |
| Hernexeos | 0597-9257 | Tablet, film coated | New drug applications (NDA) | August 8, 2025 |
| Spevigo | 0597-7705 | Injection | Biologics (BLA) | May 28, 2025 |
| Adalimumab-adbm | 0597-0575 | Kit | Biologics (BLA) | April 30, 2024 |
| Adalimumab-adbm | 0597-0565 | Kit | Biologics (BLA) | April 30, 2024 |
| Cyltezo | 0597-0495 | Kit | Biologics (BLA) | April 30, 2024 |
| Cyltezo | 0597-0485 | Kit | Biologics (BLA) | April 30, 2024 |
| Spevigo | 0597-0620 | Injection | Biologics (BLA) | March 18, 2024 |
| Adalimumab-adbm | 0597-0595 | Kit | Biologics (BLA) | October 1, 2023 |
| Adalimumab-adbm | 0597-0585 | Kit | Biologics (BLA) | October 1, 2023 |
| Adalimumab-adbm | 0597-0555 | Kit | Biologics (BLA) | October 1, 2023 |
| Adalimumab-adbm | 0597-0545 | Kit | Biologics (BLA) | October 1, 2023 |
| Cyltezo | 0597-0405 | Kit | Biologics (BLA) | July 1, 2023 |
| Cyltezo | 0597-0400 | Kit | Biologics (BLA) | July 1, 2023 |
| Cyltezo | 0597-0375 | Kit | Biologics (BLA) | July 1, 2023 |
| Cyltezo | 0597-0370 | Kit | Biologics (BLA) | July 1, 2023 |
| Spevigo | 0597-0035 | Injection | Biologics (BLA) | September 1, 2022 |
| Pradaxa | 0597-0450 | Pellet | New drug applications (NDA) | March 16, 2022 |
| Pradaxa | 0597-0445 | Pellet | New drug applications (NDA) | March 16, 2022 |
| Pradaxa | 0597-0440 | Pellet | New drug applications (NDA) | March 16, 2022 |
| Pradaxa | 0597-0435 | Pellet | New drug applications (NDA) | March 16, 2022 |
| Pradaxa | 0597-0430 | Pellet | New drug applications (NDA) | March 16, 2022 |
| Pradaxa | 0597-0425 | Pellet | New drug applications (NDA) | March 16, 2022 |
| Trijardy XR | 0597-0395 | Tablet, extended release | New drug applications (NDA) | April 23, 2020 |
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.