Drug Database
Back to search

United States· US:63323-229_1e6b19d0-9376-4cec-9eef-fea441e0263e

Protamine Sulfate

A protamine product containing protamine sulfate, registered in United States by Fresenius Kabi USA, LLC. The same ATC class is registered in 16 of our 19 countries.

ATC V03AB14US label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedProtamine SulfateATCV03AB14REGISTER NO.US:63323-229_1e6b19d0…PACKS LISTED4CHECKEDSeptember 27, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about protamine sulfateAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Protamine is registered in 16 of 19 countries.

Countries holding a registration under ATC V03AB14 (protamine), each read from that country’s own register.

  • This record: United States, from FDA National Drug Code directory (United States)
  • 10 of them publish a price we can compare per daily dose
Search protamine products by name

Protamine · ATC V03AB14

16 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Franceprice
  • Germany
  • Icelandprice
  • Ireland
  • Netherlands
  • Norwayprice
  • Polandprice
  • Spainprice
  • Switzerlandprice
  • United Kingdom
  • United Statesprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
PROTAMINE SULFATE
Manufacturer
Fresenius Kabi USA, LLC
Country
United States (US)
ATC code
V03AB14
ATC class
Protamine
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 27, 2026

Packs & prices · 4

  • ndc11
    63323-229-94
  • ndc11
    63323-229-95
  • ndc11
    6332322994
    25 VIAL, SINGLE-DOSE in 1 TRAY (63323-229-94) / 5 mL in 1 VIAL, SINGLE-DOSE (63323-229-41)
  • ndc11
    6332322995
    1 VIAL, SINGLE-DOSE in 1 BOX (63323-229-95) / 25 mL in 1 VIAL, SINGLE-DOSE

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Same medicine, other countries

Protamine in 11 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All protamine products

Authorised across Europe · EMA

The same active substance is authorised in 27 EEA countries. Names it is sold under:

  • Austria · Protaminsulfat Leo Pharma
  • Belgium · Protamine Sulfaat Leo Pharma, Protaminsulfat Leo Pharma
  • Bulgaria · Паминту
  • Czechia · Protamine Sulfate Leo Pharma
  • Germany · Protaminsulfat Leo Pharma
  • Denmark · Protaminsulfat Leo Pharma
  • Estonia · Protamine Sulphate Leo Pharma
  • Spain · Protamina Sulfato, Protamina Sulfato Leo Pharma
  • Finland · Protaminsulfat Leo Pharma
  • France · Protamine Choay
  • United Kingdom (Northern Ireland) · Prosulf, Protamine Sulphate Wockhardt Uk
  • Greece · Protamine Sulphate Leo Pharma
  • Hungary · Protamin-Szulfát Leo Pharma
  • Ireland · Protamine Sulphate Leo Pharma
  • Iceland · Protaminsulfat Leo Pharma
  • Italy · Protamina Solfato
  • Lithuania · Protamine Sulphate Leo Pharma
  • Luxembourg · Protaminsulfat Leo Pharma, Sulfate De Protamine Leo Pharma
  • Malta · Protamine Sulphate, Protamine Sulphate Leo Pharma
  • Netherlands · Protamine Sulfaat, Protamine Sulfaat Leo Pharma
  • Norway · Protaminsulfat Leo Pharma
  • Poland · Protamine, Siarczan Protaminy Wytwórnia Surowic I Szczepionek Biomed
  • Portugal · Sulfato De Protamina Leo Pharma
  • Romania · Sulfat De Protamina Leo Pharma
  • Sweden · Protaminsulfat, Protaminsulfat Leo Pharma
  • Slovenia · Protaminijev Sulfat Leo Pharma
  • Slovakia · Protamine Sulfate Leo Pharma

Source: European Medicines Agency, Article 57 product data.

Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.

For developers

The same record over the API, and the raw payload
GET /v1/drugs/80d5a61e-2c99-469c-b17f-c687c63d5359
GET /v1/drugs/80d5a61e-2c99-469c-b17f-c687c63d5359?format=fhir

Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.

{
  "route": "INTRAVENOUS",
  "source": "ndc",
  "strength": "10",
  "substance": "PROTAMINE SULFATE",
  "productndc": "63323-229",
  "dosage_form": "INJECTION, SOLUTION",
  "dea_schedule": null,
  "strength_unit": "mg/mL",
  "application_number": "ANDA089454",
  "marketing_category": "ANDA"
}
API referenceMCP serverPlans

See everything about protamine.

This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.

Try it freeOpen in the console