United States · FDA National Drug Code directory
Protamine Sulfate
A source-listed medicine record.
Factual source checks only. This page is not a clinically reviewed monograph. Historical or discontinued records may be included; listing does not confirm approval, current availability or pharmacy stock.
Medicine identity
- Source reference
- 65219-646_c76876da-b9a8-45d0-9278-7df3288d3a06
- Product NDC
- 65219-646
- Form
- INJECTION, SOLUTION
- Composition / generic term
- PROTAMINE SULFATE
- Labeler
- Fresenius Kabi USA, LLC
- Marketing category
- ANDA
- Marketing start / end (source format)
- 20250328
- Source listing expiry
- 20261231
Source-listed ingredients
- PROTAMINE SULFATE — 10 mg/mL
These values do not establish equivalence or a dose recommendation.
Packages
- 25 VIAL, SINGLE-DOSE in 1 TRAY (65219-646-05) / 5 mL in 1 VIAL, SINGLE-DOSE (65219-646-02) · 65219-646-05
Source and coverage
Open FDA National Drug Code directory →
Snapshot retrieved: 2026-09-17. This is the acquisition date, not a medical review date.
Clinical information, images and comparisons appear only when separately reviewed for this record. Coverage may be incomplete. Ask a pharmacist or clinician about your treatment.
Browse United States records →