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Armour Thyroid

Armour Thyroid (thyroid tablets, USP)

Approved
Approval ID

c815faa3-1d02-4680-96ef-5fad1645e99b

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 22, 2023

Manufacturers
FDA

PD-Rx Pharmaceuticals, Inc.

DUNS: 156893695

Products 1

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

THYROID, PORCINE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code55289-261
Product Classification
G
Generic Name
THYROID, PORCINE
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 22, 2023
FDA Product Classification

INGREDIENTS (5)

CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
DEXTROSEInactive
Code: IY9XDZ35W2
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SUS SCROFA THYROIDActive
Quantity: 60 mg in 1 1
Code: 6RV024OAUQ
Classification: ACTIB

Drug Labeling Information

DESCRIPTION SECTION

LOINC: 34089-3Updated: 5/24/2017

DESCRIPTION

Armour ® Thyroid (thyroid tablets, USP)* for oral use is a natural preparation derived from porcine thyroid glands and has a strong, characteristic odor. (T 3 liothyronine is approximately four times as potent as T 4 levothyroxine on a microgram for microgram basis.) They provide 38 mcg levothyroxine (T 4) and 9 mcg liothyronine (T 3) per grain of thyroid. The inactive ingredients are calcium stearate, dextrose, microcrystalline cellulose, sodium starch glycolate and opadry white.

STRUCTURAL FORMULAS

Structural Formulas

HOW SUPPLIED SECTION

LOINC: 34069-5Updated: 5/24/2017

HOW SUPPLIED

Armour ® Thyroid (thyroid tablets, USP) are supplied as follows:

60 mg (1 grain) are available in bottles of 30 (NDC 55289-261-30) and bottles of 90 (NDC 55289-261-90).

Armour ® Thyroid (thyroid tablets, USP) is evenly colored, light tan, round tablets, with convex surfaces. One side is debossed with a mortar and pestle beneath the letter “A” on the top and strength code letters on the bottom as defined below

Strength

Code

1 grain

TE

Note: (T 3 liothyronine is approximately four times as potent as T 4 levothyroxine on a microgram for microgram basis.)

Store in a tight container protected from light and moisture. Store between 15°C and 30°C (59°F and 86°F).

  • Armour ® Thyroid (thyroid tablets, USP) has not been approved by FDA as a new drug.

ARMOUR ® is a registered trademark of Allergan Sales, LLC
Allergan® and its design are trademarks of Allergan, Inc.

Revised: June 2018

v.1.0USPI0457

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