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FDA Approval

LEVOTHYROXINE SODIUM

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
NorthStar RxLLC
DUNS: 830546433
Effective Date
April 15, 2025
Labeling Type
Human Prescription Drug Label
Levothyroxine(50 ug in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Macleods Pharmaceuticals Limited

NorthStar RxLLC

650376184

Products11

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

LEVOTHYROXINE SODIUM

Product Details

NDC Product Code
72603-661
Application Number
ANDA211417
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
April 15, 2025
LevothyroxineActive
Code: 9J765S329GClass: ACTIRQuantity: 50 ug in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UIClass: IACT

LEVOTHYROXINE SODIUM

Product Details

NDC Product Code
72603-667
Application Number
ANDA211417
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
April 15, 2025
LevothyroxineActive
Code: 9J765S329GClass: ACTIRQuantity: 137 ug in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UIClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT

LEVOTHYROXINE SODIUM

Product Details

NDC Product Code
72603-663
Application Number
ANDA211417
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
April 15, 2025
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UIClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
LevothyroxineActive
Code: 9J765S329GClass: ACTIRQuantity: 88 ug in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT

LEVOTHYROXINE SODIUM

Product Details

NDC Product Code
72603-701
Application Number
ANDA211417
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
April 15, 2025
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
LevothyroxineActive
Code: 9J765S329GClass: ACTIRQuantity: 200 ug in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UIClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT

LEVOTHYROXINE SODIUM

Product Details

NDC Product Code
72603-664
Application Number
ANDA211417
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
April 15, 2025
LevothyroxineActive
Code: 9J765S329GClass: ACTIRQuantity: 100 ug in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UIClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT

LEVOTHYROXINE SODIUM

Product Details

NDC Product Code
72603-669
Application Number
ANDA211417
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
April 15, 2025
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UIClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
LevothyroxineActive
Code: 9J765S329GClass: ACTIRQuantity: 175 ug in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT

LEVOTHYROXINE SODIUM

Product Details

NDC Product Code
72603-665
Application Number
ANDA211417
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
April 15, 2025
LevothyroxineActive
Code: 9J765S329GClass: ACTIRQuantity: 112 ug in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UIClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT

LEVOTHYROXINE SODIUM

Product Details

NDC Product Code
72603-662
Application Number
ANDA211417
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
April 15, 2025
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
LevothyroxineActive
Code: 9J765S329GClass: ACTIRQuantity: 75 ug in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UIClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT

LEVOTHYROXINE SODIUM

Product Details

NDC Product Code
72603-668
Application Number
ANDA211417
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
April 15, 2025
LevothyroxineActive
Code: 9J765S329GClass: ACTIRQuantity: 150 ug in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UIClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT

LEVOTHYROXINE SODIUM

Product Details

NDC Product Code
72603-660
Application Number
ANDA211417
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
April 15, 2025
LevothyroxineActive
Code: 9J765S329GClass: ACTIRQuantity: 25 ug in 1 1
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UIClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
Showing 1 to 10 of 11 products

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RECENT MAJOR CHANGES SECTION

DESCRIPTION SECTION

CLINICAL PHARMACOLOGY SECTION

INDICATIONS & USAGE SECTION

DOSAGE & ADMINISTRATION SECTION

DOSAGE FORMS & STRENGTHS SECTION

CONTRAINDICATIONS SECTION

BOXED WARNING SECTION

WARNINGS AND PRECAUTIONS SECTION

DRUG INTERACTIONS SECTION

USE IN SPECIFIC POPULATIONS SECTION

ADVERSE REACTIONS SECTION

OVERDOSAGE SECTION

NONCLINICAL TOXICOLOGY SECTION

INFORMATION FOR PATIENTS SECTION

HOW SUPPLIED SECTION

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