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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
- ndc1143825200011 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"
}Related drugs
Other records sharing ATC code H01BA04.
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