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

Terlivaz

Orange BookUNIISPLATC H01BA04

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerMallinckrodt Hospital Products Inc.
CountryUS (United States)
ATC codeH01BA04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

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

Annotations

UNII (FDA Substance ID)
7Z5X49W53P
TERLIPRESSIN
RxCUI 57048
Orange Book
N022231
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "7Z5X49W53P",
    "rxcui": "57048",
    "inchikey": null,
    "display_name": "TERLIPRESSIN",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "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"
}

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