MedPath

NP Thyroid

Approved
Approval ID

3c270b9a-05c2-6a30-e063-6394a90a2844

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 12, 2025

Manufacturers
FDA

Calvin Scott & Co Inc.

DUNS: 073404626

Products 1

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

Thyroid tablets

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code17224-511
Product Classification
G
Generic Name
Thyroid tablets
Product Specifications
Route of AdministrationORAL
Effective DateAugust 12, 2025
FDA Product Classification

INGREDIENTS (6)

LIOTHYRONINEActive
Quantity: 2.25 ug in 1 1
Code: 06LU7C9H1V
Classification: ACTIB
DEXTROSE MONOHYDRATEInactive
Code: LX22YL083G
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
LEVOTHYROXINEActive
Quantity: 9.5 ug in 1 1
Code: Q51BO43MG4
Classification: ACTIB
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/1/2025

17224-511-60

17224-511-60Package label for NP Thyroid 15 mg tablets (60 tablets per bottle). Contains product name, dosage strength, NDC 17224-511-60, manufacturer/repacker name, and usage instructions as printed on the label.

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/1/2025

Used as a thyroid hormone replacement for hypothyroidism.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/1/2025

Thyroid hormone replacement

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/1/2025

Thyroid 15 mg

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 8/1/2025

Keep out of reach of children. In case of accidental overdose, contact a doctor or Poison Control Center immediately.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/1/2025

Take 1 tablet daily on an empty stomach or as directed.

WARNINGS SECTION

LOINC: 34071-1Updated: 8/1/2025

Do not exceed recommended dose. Keep out of reach of children.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/1/2025

Calcium stearate, dextrose, maltodextrin, mineral oil, modified wheat starch

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NP Thyroid - FDA Drug Approval Details