LEVOTHYROXINE SODIUM
These highlights do not include all the information needed to use LEVOTHYROXINE SODIUM TABLETS safely and effectively. See full prescribing information for LEVOTHYROXINE SODIUM TABLETS. LEVOTHYROXINE SODIUM tablets, for oral use Initial U.S. Approval: 2002
Approved
Approval ID
58f4dc90-3648-49dc-a7e1-baf918a773b5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 15, 2025
Manufacturers
FDA
NorthStar RxLLC
DUNS: 830546433
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 Code72603-661
Application NumberANDA211417
Product Classification
M
Marketing Category
C73584
G
Generic Name
LEVOTHYROXINE SODIUM
Product Specifications
Route of AdministrationORAL
Effective DateApril 15, 2025
FDA Product Classification
INGREDIENTS (5)
LEVOTHYROXINE SODIUMActive
Quantity: 50 ug in 1 1
Code: 9J765S329G
Classification: ACTIR
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
LEVOTHYROXINE SODIUM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72603-667
Application NumberANDA211417
Product Classification
M
Marketing Category
C73584
G
Generic Name
LEVOTHYROXINE SODIUM
Product Specifications
Route of AdministrationORAL
Effective DateApril 15, 2025
FDA Product Classification
INGREDIENTS (6)
LEVOTHYROXINE SODIUMActive
Quantity: 137 ug in 1 1
Code: 9J765S329G
Classification: ACTIR
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
LEVOTHYROXINE SODIUM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72603-663
Application NumberANDA211417
Product Classification
M
Marketing Category
C73584
G
Generic Name
LEVOTHYROXINE SODIUM
Product Specifications
Route of AdministrationORAL
Effective DateApril 15, 2025
FDA Product Classification
INGREDIENTS (7)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
LEVOTHYROXINE SODIUMActive
Quantity: 88 ug in 1 1
Code: 9J765S329G
Classification: ACTIR
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LEVOTHYROXINE SODIUM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72603-701
Application NumberANDA211417
Product Classification
M
Marketing Category
C73584
G
Generic Name
LEVOTHYROXINE SODIUM
Product Specifications
Route of AdministrationORAL
Effective DateApril 15, 2025
FDA Product Classification
INGREDIENTS (6)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LEVOTHYROXINE SODIUMActive
Quantity: 200 ug in 1 1
Code: 9J765S329G
Classification: ACTIR
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
LEVOTHYROXINE SODIUM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72603-664
Application NumberANDA211417
Product Classification
M
Marketing Category
C73584
G
Generic Name
LEVOTHYROXINE SODIUM
Product Specifications
Route of AdministrationORAL
Effective DateApril 15, 2025
FDA Product Classification
INGREDIENTS (7)
LEVOTHYROXINE SODIUMActive
Quantity: 100 ug in 1 1
Code: 9J765S329G
Classification: ACTIR
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
LEVOTHYROXINE SODIUM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72603-669
Application NumberANDA211417
Product Classification
M
Marketing Category
C73584
G
Generic Name
LEVOTHYROXINE SODIUM
Product Specifications
Route of AdministrationORAL
Effective DateApril 15, 2025
FDA Product Classification
INGREDIENTS (7)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
LEVOTHYROXINE SODIUMActive
Quantity: 175 ug in 1 1
Code: 9J765S329G
Classification: ACTIR
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
LEVOTHYROXINE SODIUM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72603-665
Application NumberANDA211417
Product Classification
M
Marketing Category
C73584
G
Generic Name
LEVOTHYROXINE SODIUM
Product Specifications
Route of AdministrationORAL
Effective DateApril 15, 2025
FDA Product Classification
INGREDIENTS (6)
LEVOTHYROXINE SODIUMActive
Quantity: 112 ug in 1 1
Code: 9J765S329G
Classification: ACTIR
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
LEVOTHYROXINE SODIUM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72603-662
Application NumberANDA211417
Product Classification
M
Marketing Category
C73584
G
Generic Name
LEVOTHYROXINE SODIUM
Product Specifications
Route of AdministrationORAL
Effective DateApril 15, 2025
FDA Product Classification
INGREDIENTS (7)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LEVOTHYROXINE SODIUMActive
Quantity: 75 ug in 1 1
Code: 9J765S329G
Classification: ACTIR
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
LEVOTHYROXINE SODIUM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72603-668
Application NumberANDA211417
Product Classification
M
Marketing Category
C73584
G
Generic Name
LEVOTHYROXINE SODIUM
Product Specifications
Route of AdministrationORAL
Effective DateApril 15, 2025
FDA Product Classification
INGREDIENTS (6)
LEVOTHYROXINE SODIUMActive
Quantity: 150 ug in 1 1
Code: 9J765S329G
Classification: ACTIR
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
LEVOTHYROXINE SODIUM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72603-660
Application NumberANDA211417
Product Classification
M
Marketing Category
C73584
G
Generic Name
LEVOTHYROXINE SODIUM
Product Specifications
Route of AdministrationORAL
Effective DateApril 15, 2025
FDA Product Classification
INGREDIENTS (6)
LEVOTHYROXINE SODIUMActive
Quantity: 25 ug in 1 1
Code: 9J765S329G
Classification: ACTIR
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 4/15/2025
BOXED WARNING SECTION
LOINC: 34066-1Updated: 4/15/2025
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 4/15/2025
CONTRAINDICATIONS SECTION
LOINC: 34070-3Updated: 4/15/2025
WARNINGS AND PRECAUTIONS SECTION
LOINC: 43685-7Updated: 4/15/2025
ADVERSE REACTIONS SECTION
LOINC: 34084-4Updated: 4/15/2025
DRUG INTERACTIONS SECTION
LOINC: 34073-7Updated: 4/15/2025
RECENT MAJOR CHANGES SECTION
LOINC: 43683-2Updated: 4/15/2025
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 4/15/2025
DOSAGE FORMS & STRENGTHS SECTION
LOINC: 43678-2Updated: 4/15/2025
USE IN SPECIFIC POPULATIONS SECTION
LOINC: 43684-0Updated: 4/15/2025
CLINICAL PHARMACOLOGY SECTION
LOINC: 34090-1Updated: 4/15/2025
OVERDOSAGE SECTION
LOINC: 34088-5Updated: 4/15/2025
DESCRIPTION SECTION
LOINC: 34089-3Updated: 4/15/2025
NONCLINICAL TOXICOLOGY SECTION
LOINC: 43680-8Updated: 4/15/2025
HOW SUPPLIED SECTION
LOINC: 34069-5Updated: 4/15/2025
INFORMATION FOR PATIENTS SECTION
LOINC: 34076-0Updated: 4/15/2025