Tirosint
These highlights do not include all the information needed to use TIROSINT -SOL safely and effectively. See full prescribing information for TIROSINT -SOL. Initial U.S. Approval: 2000
Approved
Approval ID
5d378add-f13d-40f2-99dc-0f2340ab44b7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 30, 2023
Manufacturers
FDA
IBSA Pharma Inc.
DUNS: 081215551
Products 10
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Levothyroxine Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71858-0145
Application NumberNDA206977
Product Classification
M
Marketing Category
C73594
G
Generic Name
Levothyroxine Sodium
Product Specifications
Route of AdministrationORAL
Effective DateNovember 30, 2023
FDA Product Classification
INGREDIENTS (3)
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
LEVOTHYROXINE SODIUMActive
Quantity: 137 ug in 1 mL
Code: 9J765S329G
Classification: ACTIR
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Levothyroxine Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71858-0150
Application NumberNDA206977
Product Classification
M
Marketing Category
C73594
G
Generic Name
Levothyroxine Sodium
Product Specifications
Route of AdministrationORAL
Effective DateNovember 30, 2023
FDA Product Classification
INGREDIENTS (3)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
LEVOTHYROXINE SODIUMActive
Quantity: 150 ug in 1 mL
Code: 9J765S329G
Classification: ACTIR
Levothyroxine Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71858-0155
Application NumberNDA206977
Product Classification
M
Marketing Category
C73594
G
Generic Name
Levothyroxine Sodium
Product Specifications
Route of AdministrationORAL
Effective DateNovember 30, 2023
FDA Product Classification
INGREDIENTS (3)
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
LEVOTHYROXINE SODIUMActive
Quantity: 175 ug in 1 mL
Code: 9J765S329G
Classification: ACTIR
Levothyroxine Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71858-0130
Application NumberNDA206977
Product Classification
M
Marketing Category
C73594
G
Generic Name
Levothyroxine Sodium
Product Specifications
Route of AdministrationORAL
Effective DateNovember 30, 2023
FDA Product Classification
INGREDIENTS (3)
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
LEVOTHYROXINE SODIUMActive
Quantity: 100 ug in 1 mL
Code: 9J765S329G
Classification: ACTIR
Levothyroxine Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71858-0113
Application NumberNDA206977
Product Classification
M
Marketing Category
C73594
G
Generic Name
Levothyroxine Sodium
Product Specifications
Route of AdministrationORAL
Effective DateNovember 30, 2023
FDA Product Classification
INGREDIENTS (3)
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
LEVOTHYROXINE SODIUMActive
Quantity: 44 ug in 1 mL
Code: 9J765S329G
Classification: ACTIR
Levothyroxine Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71858-0120
Application NumberNDA206977
Product Classification
M
Marketing Category
C73594
G
Generic Name
Levothyroxine Sodium
Product Specifications
Route of AdministrationORAL
Effective DateNovember 30, 2023
FDA Product Classification
INGREDIENTS (3)
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
LEVOTHYROXINE SODIUMActive
Quantity: 75 ug in 1 mL
Code: 9J765S329G
Classification: ACTIR
Levothyroxine Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71858-0112
Application NumberNDA206977
Product Classification
M
Marketing Category
C73594
G
Generic Name
Levothyroxine Sodium
Product Specifications
Route of AdministrationORAL
Effective DateNovember 30, 2023
FDA Product Classification
INGREDIENTS (3)
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
LEVOTHYROXINE SODIUMActive
Quantity: 37.5 ug in 1 mL
Code: 9J765S329G
Classification: ACTIR
Levothyroxine Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71858-0160
Application NumberNDA206977
Product Classification
M
Marketing Category
C73594
G
Generic Name
Levothyroxine Sodium
Product Specifications
Route of AdministrationORAL
Effective DateNovember 30, 2023
FDA Product Classification
INGREDIENTS (3)
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
LEVOTHYROXINE SODIUMActive
Quantity: 200 ug in 1 mL
Code: 9J765S329G
Classification: ACTIR
Levothyroxine Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71858-0115
Application NumberNDA206977
Product Classification
M
Marketing Category
C73594
G
Generic Name
Levothyroxine Sodium
Product Specifications
Route of AdministrationORAL
Effective DateNovember 30, 2023
FDA Product Classification
INGREDIENTS (3)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
LEVOTHYROXINE SODIUMActive
Quantity: 50 ug in 1 mL
Code: 9J765S329G
Classification: ACTIR
Levothyroxine Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71858-0110
Application NumberNDA206977
Product Classification
M
Marketing Category
C73594
G
Generic Name
Levothyroxine Sodium
Product Specifications
Route of AdministrationORAL
Effective DateNovember 30, 2023
FDA Product Classification
INGREDIENTS (3)
LEVOTHYROXINE SODIUMActive
Quantity: 25 ug in 1 mL
Code: 9J765S329G
Classification: ACTIR
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT