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FDA Approval

Levothyroxine sodium

CompanyNuCare Pharmaceuticals,Inc. (DUNS: 010632300)

Effective Date

April 24, 2019

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Levothyroxine(75 ug in 1 1)

Manufacturing Establishments (1)

NuCare Pharmaceuticals,Inc.

Labeler

NuCare Pharmaceuticals,Inc.

DUNS Number

010632300

Products (1)

Levothyroxine sodium

NDC Product Code

68071-4625

Application Number

NDA021342

Marketing Category

NDA authorized generic (C73605)

Route of Administration

ORAL

Effective Date

April 24, 2019

Ingredients

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

LevothyroxineActive

Code: 9J765S329GClass: ACTIRQuantity: 75 ug in 1 1

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