Data / Drug companies / Protamine sulfate
Protamine sulfate: 3 companies and 5 products in the FDA NDC directory
Protamine sulfate is listed in the FDA National Drug Code Directory by 3 companies, with 5 products in commercial distribution. 5 of the products (100.0%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are injection, solution, and the newest product started marketing on March 28, 2025.
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- Companies listing it
- 3
- Products
- 5
- Generic (ANDA) products
- 5 (100.0%)
- Application numbers
- 1
- Routes
- Intravenous
- openFDA record search
- api.fda.gov
Companies that list protamine sulfate
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Fresenius Kabi USA, LLC | 3 | injection, solution | Generic drugs (ANDA) | October 18, 2000 |
| Fresenius Kabi USA, LLC | 1 | injection, solution | Generic drugs (ANDA) | March 28, 2025 |
| HF Acquisition Co LLC, DBA HealthFirst | 1 | injection, solution | Generic drugs (ANDA) | October 13, 2019 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Injection, solution | 5 | 100% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 5 | 100% |
Pharmacologic classes
| Class | Products |
|---|---|
| Heparin Reversal Agent | 5 |
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.