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
63323-229_1e6b19d0-9376-4cec-9eef-fea441e0263e
Product NDC
63323-229
Form
INJECTION, SOLUTION
Composition / generic term
PROTAMINE SULFATE
Labeler
Fresenius Kabi USA, LLC
Marketing category
ANDA
Marketing start / end (source format)
20001018
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 (63323-229-94) / 5 mL in 1 VIAL, SINGLE-DOSE (63323-229-41) · 63323-229-94
  • 1 VIAL, SINGLE-DOSE in 1 BOX (63323-229-95) / 25 mL in 1 VIAL, SINGLE-DOSE · 63323-229-95

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.

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Protamine Sulfate — United States | Molindra Medicines