Tirosint
These highlights do not include all the information needed to use TIROSINT® safely and effectively. See full prescribing information for TIROSINT. TIROSINT® (levothyroxine sodium) capsules, for oral use Initial U.S. Approval: 2000
Approved
Approval ID
7a7ade79-0165-4e31-b84e-667416c00c7e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 27, 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 Code71858-0050
Application NumberNDA021924
Product Classification
M
Marketing Category
C73594
G
Generic Name
levothyroxine sodium
Product Specifications
Route of AdministrationORAL
Effective DateNovember 27, 2023
FDA Product Classification
INGREDIENTS (4)
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
LEVOTHYROXINE SODIUMActive
Quantity: 150 ug in 1 1
Code: 9J765S329G
Classification: ACTIR
levothyroxine sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71858-0015
Application NumberNDA021924
Product Classification
M
Marketing Category
C73594
G
Generic Name
levothyroxine sodium
Product Specifications
Route of AdministrationORAL
Effective DateNovember 27, 2023
FDA Product Classification
INGREDIENTS (4)
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
LEVOTHYROXINE SODIUMActive
Quantity: 50 ug in 1 1
Code: 9J765S329G
Classification: ACTIR
levothyroxine sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71858-0017
Application NumberNDA021924
Product Classification
M
Marketing Category
C73594
G
Generic Name
levothyroxine sodium
Product Specifications
Route of AdministrationORAL
Effective DateNovember 27, 2023
FDA Product Classification
INGREDIENTS (4)
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
LEVOTHYROXINE SODIUMActive
Quantity: 62.5 ug in 1 1
Code: 9J765S329G
Classification: ACTIR
levothyroxine sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71858-0010
Application NumberNDA021924
Product Classification
M
Marketing Category
C73594
G
Generic Name
levothyroxine sodium
Product Specifications
Route of AdministrationORAL
Effective DateNovember 27, 2023
FDA Product Classification
INGREDIENTS (4)
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
LEVOTHYROXINE SODIUMActive
Quantity: 25 ug in 1 1
Code: 9J765S329G
Classification: ACTIR
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
levothyroxine sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71858-0060
Application NumberNDA021924
Product Classification
M
Marketing Category
C73594
G
Generic Name
levothyroxine sodium
Product Specifications
Route of AdministrationORAL
Effective DateNovember 27, 2023
FDA Product Classification
INGREDIENTS (4)
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
LEVOTHYROXINE SODIUMActive
Quantity: 200 ug in 1 1
Code: 9J765S329G
Classification: ACTIR
levothyroxine sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71858-0013
Application NumberNDA021924
Product Classification
M
Marketing Category
C73594
G
Generic Name
levothyroxine sodium
Product Specifications
Route of AdministrationORAL
Effective DateNovember 27, 2023
FDA Product Classification
INGREDIENTS (4)
LEVOTHYROXINE SODIUMActive
Quantity: 44 ug in 1 1
Code: 9J765S329G
Classification: ACTIR
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
levothyroxine sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71858-0005
Application NumberNDA021924
Product Classification
M
Marketing Category
C73594
G
Generic Name
levothyroxine sodium
Product Specifications
Route of AdministrationORAL
Effective DateNovember 27, 2023
FDA Product Classification
INGREDIENTS (4)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
LEVOTHYROXINE SODIUMActive
Quantity: 13 ug in 1 1
Code: 9J765S329G
Classification: ACTIR
levothyroxine sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71858-0035
Application NumberNDA021924
Product Classification
M
Marketing Category
C73594
G
Generic Name
levothyroxine sodium
Product Specifications
Route of AdministrationORAL
Effective DateNovember 27, 2023
FDA Product Classification
INGREDIENTS (4)
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
LEVOTHYROXINE SODIUMActive
Quantity: 112 ug in 1 1
Code: 9J765S329G
Classification: ACTIR
levothyroxine sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71858-0055
Application NumberNDA021924
Product Classification
M
Marketing Category
C73594
G
Generic Name
levothyroxine sodium
Product Specifications
Route of AdministrationORAL
Effective DateNovember 27, 2023
FDA Product Classification
INGREDIENTS (4)
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
LEVOTHYROXINE SODIUMActive
Quantity: 175 ug in 1 1
Code: 9J765S329G
Classification: ACTIR
levothyroxine sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71858-0020
Application NumberNDA021924
Product Classification
M
Marketing Category
C73594
G
Generic Name
levothyroxine sodium
Product Specifications
Route of AdministrationORAL
Effective DateNovember 27, 2023
FDA Product Classification
INGREDIENTS (4)
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
LEVOTHYROXINE SODIUMActive
Quantity: 75 ug in 1 1
Code: 9J765S329G
Classification: ACTIR