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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
Effective Date
February 17, 2021
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Levothyroxine(100 ug in 1 1)

Manufacturing Establishments1

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

NuCare Pharmaceuticals,Inc.

NuCare Pharmaceuticals,Inc.

010632300

Products1

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
68071-4866
Application Number
NDA021342
Marketing Category
NDA authorized generic (C73605)
Route of Administration
ORAL
Effective Date
February 17, 2021
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
Code: 9J765S329GClass: ACTIRQuantity: 100 ug in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
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