TEZRULY
These highlights do not include all the information needed to use TEZRULY safely and effectively. See full prescribing information for TEZRULY. TEZRULY (terazosin) oral solution Initial U.S. Approval: 1993
Approved
Approval ID
69582e0c-6569-490c-8c14-999f3750336f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 18, 2025
Manufacturers
FDA
ANI Pharmaceuticals, Inc.
DUNS: 145588013
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Terazosin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70954-592
Application NumberNDA218139
Product Classification
M
Marketing Category
C73594
G
Generic Name
Terazosin
Product Specifications
Route of AdministrationORAL
Effective DateApril 18, 2025
FDA Product Classification
INGREDIENTS (9)
TERAZOSIN HYDROCHLORIDEActive
Quantity: 1 mg in 1 mL
Code: D32S14F082
Classification: ACTIM
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 8/20/2024
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 8/20/2024
CONTRAINDICATIONS SECTION
LOINC: 34070-3Updated: 8/20/2024
WARNINGS AND PRECAUTIONS SECTION
LOINC: 43685-7Updated: 8/20/2024
ADVERSE REACTIONS SECTION
LOINC: 34084-4Updated: 8/20/2024
DRUG INTERACTIONS SECTION
LOINC: 34073-7Updated: 8/20/2024
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 8/20/2024
DOSAGE FORMS & STRENGTHS SECTION
LOINC: 43678-2Updated: 8/20/2024
USE IN SPECIFIC POPULATIONS SECTION
LOINC: 43684-0Updated: 8/20/2024
OVERDOSAGE SECTION
LOINC: 34088-5Updated: 8/20/2024
DESCRIPTION SECTION
LOINC: 34089-3Updated: 8/20/2024
CLINICAL PHARMACOLOGY SECTION
LOINC: 34090-1Updated: 8/20/2024
NONCLINICAL TOXICOLOGY SECTION
LOINC: 43680-8Updated: 8/20/2024
CLINICAL STUDIES SECTION
LOINC: 34092-7Updated: 8/20/2024
HOW SUPPLIED SECTION
LOINC: 34069-5Updated: 8/20/2024
INFORMATION FOR PATIENTS SECTION
LOINC: 34076-0Updated: 8/20/2024
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 8/20/2024