Levothyroxine sodium

Basic Information

Product Name

FDA Product Code

50090-6104

Regulatory Information

NDC Product Code

50090-6104

Application Number

ANDA212399

Marketing Category

C73584

Effective Date

January 2, 2023

Territorial Authority

USA

FDA Title

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

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

FD&C BLUE NO. 2

Code: L06K8R7DQK

Class Code: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATO

Code: 5856J3G2A2

Class Code: IACT

SODIUM STEARYL FUMARATE

Code: 7CV7WJK4UI

Class Code: IACT

MAGNESIUM OXIDE

Code: 3A3U0GI71G

Class Code: IACT

LEVOTHYROXINE SODIUM

Quantity: 150 ug in 1 1

Code: 9J765S329G

Class Code: ACTIR

Active Moieties

LEVOTHYROXINE

Code: Q51BO43MG4

Basic Information

Regulatory Information

Company Information

Active Ingredients

MICROCRYSTALLINE CELLULOSE

FD&C BLUE NO. 2

SODIUM STARCH GLYCOLATE TYPE A POTATO

SODIUM STEARYL FUMARATE

MAGNESIUM OXIDE

Active Moieties

LEVOTHYROXINE