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United States· US:43825-200_1d0832a2-debc-40bf-8bbe-59383d0bd3c6

Terlivaz

A terlipressin product containing terlipressin, registered in United States by Mallinckrodt Hospital Products Inc.. The same ATC class is registered in 15 of our 19 countries.

ATC H01BA04Orange BookUS 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…normalisedTerlivazATCH01BA04REGISTER NO.US:43825-200_1d0832a2…PACKS LISTED1CHECKEDSeptember 12, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about terlipressinAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Terlipressin is registered in 15 of 19 countries.

Countries holding a registration under ATC H01BA04 (terlipressin), each read from that country’s own register.

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

Terlipressin · ATC H01BA04

15 / 19 countries

  • Belgiumprice
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Franceprice
  • Germany
  • Icelandprice
  • Ireland
  • Netherlands
  • Norwayprice
  • Polandprice
  • Sweden
  • 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
Terlipressin
Manufacturer
Mallinckrodt Hospital Products Inc.
Country
United States (US)
ATC code
H01BA04
ATC class
Terlipressin
Defined daily dose
12 mg, P
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 12, 2026

Packs & prices · 1

  • ndc11
    4382520001
    1 VIAL, SINGLE-DOSE in 1 CARTON (43825-200-01) / 5 mL in 1 VIAL, SINGLE-DOSE

Regulatory notes

UNII (FDA substance ID)
7Z5X49W53P
TERLIPRESSIN
RxCUI 57048
Orange Book
N022231
DailyMed SPL labels
1 version tracked

Same medicine, other countries

Terlipressin in 9 other countries

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

All terlipressin products

Authorised across Europe · EMA

The same active substance is authorised in 13 EEA countries. Names it is sold under:

  • Austria · Glycylpressin, Terlipressinacetat Ever Pharma
  • Bulgaria · Терлипресин Ацетат Ever Pharma
  • Czechia · Remestyp, Terlipresin Acetát Ever Pharma
  • Germany · Glycylpressin, Terlipressinacetat Ever Pharma
  • Spain · Terlipresina Acetato Ever Pharma
  • France · Acetate De Terlipressine Ever Pharma
  • Hungary · Glypressin
  • Ireland · Terlipressin Acetate Ever Pharma
  • Italy · Glipressina, Terlipressina Acetato Ever Pharma
  • Poland · Terlipressini Acetas Ever Pharma
  • Portugal · Glypressine, Terlipressina Ever Pharma
  • Romania · Acetat De Terlipresină Ever Pharma
  • Slovakia · Remestyp, Terlipresín Ever 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/853f01fe-b940-451d-81db-f58e9d3985bf
GET /v1/drugs/853f01fe-b940-451d-81db-f58e9d3985bf?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.

{
  "unii": {
    "unii": "7Z5X49W53P",
    "rxcui": "57048",
    "inchikey": null,
    "display_name": "TERLIPRESSIN",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "livertox": {
    "summary": null,
    "livertox_id": null,
    "hepatotoxicity_score": null
  },
  "spl_meta": {
    "3a35b86c-f451-4fac-8499-43019e4da354": {
      "match": "brand_token",
      "title": "TERLIVAZ (TERLIPRESSIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MALLINCKRODT HOSPITAL PRODUCTS INC.]",
      "spl_version": "6",
      "published_date": "2025-11-17"
    }
  },
  "productid": "43825-200_1d0832a2-debc-40bf-8bbe-59383d0bd3c6",
  "productndc": "43825-200",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "022231",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.85MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Sep 14, 2022"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TERLIPRESSIN",
  "proprietary_name": "Terlivaz",
  "active_ingred_unit": "mg/5mL",
  "application_number": "NDA022231",
  "marketing_category": "NDA",
  "nonproprietary_name": "Terlipressin",
  "start_marketing_date": "20220914",
  "active_numerator_strength": ".85"
}
API referenceMCP serverPlans

See everything about terlipressin.

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.

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