Terlivaz
These highlights do not include all the information needed to use TERLIVAZ safely and effectively. See full prescribing information for TERLIVAZ. TERLIVAZ (terlipressin) for injection, for intravenous use Initial U.S. Approval: 2022
Approved
Approval ID
3a35b86c-f451-4fac-8499-43019e4da354
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 11, 2023
Manufacturers
FDA
Mallinckrodt Hospital Products Inc.
DUNS: 163837383
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Terlipressin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43825-200
Application NumberNDA022231
Product Classification
M
Marketing Category
C73594
G
Generic Name
Terlipressin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 1, 2023
FDA Product Classification
INGREDIENTS (1)
TerlipressinActive
Quantity: 0.85 mg in 5 mL
Code: 7Z5X49W53P
Classification: ACTIB