Active ingredient
Protamine Sulfate (Usp)
5 finished FDA listings contain Protamine Sulfate (Usp) as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- PROTAMINE SULFATE
- Dosage forms
- Injection, Solution
- Routes
- Intravenous
- Manufacturers / labelers
- 2
- Strengths listed
- 10 mg/ml
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 8825
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| ANDA 089454 | FRESENIUS KABI USA | 1987-04-07 | 5 |
Official labeling on DailyMed
- PROTAMINE SULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] · version 1 · 2025-05-15
- PROTAMINE SULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] · version 6 · 2025-02-14
- PROTAMINE SULFATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] · version 4 · 2024-04-02
- PROTAMINE SULFATE (PROTAMINE SULFATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] · version 5 · 2024-02-08
- PROTAMINE SULFATE INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] · version 4 · 2024-01-23
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.