NDC 60846-801 Unithroid
Levothyroxine Sodium Tablet Oral

Product Information

Product Code60846-801
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Unithroid
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Levothyroxine Sodium
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Human Prescription Drug
Dosage FormTablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Oral - Administration to or by way of the mouth.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Amneal Pharmaceuticals Llc
Labeler Code60846
FDA Application Number What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
NDA021210
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
07-03-2014
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
12-31-2022
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

Usage Information


Product Characteristics

Color(s)ORANGE (C48331 - PEACH)
ShapeROUND (C48348)
Size(s)7 MM
Imprint(s)JSP;513
Score2

Product Packages

NDC 60846-801-01

Package Description: 100 TABLET in 1 BOTTLE

Price per Unit: $2.94465 per EA

Product Details

Unithroid is a human prescription drug product labeled by Amneal Pharmaceuticals Llc. The generic name of Unithroid is levothyroxine sodium. The product's dosage form is tablet and is administered via oral form.


What are Unithroid Active Ingredients?

The following is the list of active ingredients in this product. An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.


NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:


Inactive Ingredient(s)

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • LACTOSE (UNII: J2B2A4N98G)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • ACACIA (UNII: 5C5403N26O)
  • SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)


Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.


* Please review the disclaimer below.

Patient Education

Levothyroxine

Levothyroxine is pronounced as (lee voe thye rox' een)

Why is levothyroxine medication prescribed?
Levothyroxine, a thyroid hormone, is used to treat hypothyroidism, a condition where the thyroid gland does not produce enough thyroid hormone.Levothyroxine is also used ...
[Read More]

* Please review the disclaimer below.

Unithroid Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Storage Conditions



20°C to 25°C (68°F to 77°F) with excursions between 15°C to 30°C (59°F to 86°F)

Rx only

Manufactured by:
Jerome Stevens Pharmaceuticals, Inc.
Bohemia, NY 11716

Distributed by:
Gemini Laboratories
Bridgewater, NJ 08807

Rev. 04/14

MG #15106


Principal Display Panel - 25 Mcg (0.025 Mg)



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NDC 60846-801-01

UNITHROID®

(Levothyroxine
Sodium Tablets, USP)

25 mcg
(0.025 mg)

Rx ONLY

100 TABLETS


Principal Display Panel - 50 Mcg (0.05 Mg)



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NDC 60846-802-01

UNITHROID®

(Levothyroxine
Sodium Tablets, USP)

50 mcg
(0.05 mg)

Rx ONLY

100 TABLETS


Principal Display Panel - 75 Mcg (0.075 Mg)



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NDC 60846-803-01

UNITHROID®

(Levothyroxine
Sodium Tablets, USP)

75 mcg
(0.075 mg)

Rx ONLY

100 TABLETS


Principal Display Panel - 88 Mcg (0.088 Mg)



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NDC 60846-804-01

UNITHROID®

(Levothyroxine
Sodium Tablets, USP)

88 mcg
(0.088 mg)

Rx ONLY

100 TABLETS


Principal Display Panel - 100 Mcg (0.1 Mg)



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NDC 60846-805-01

UNITHROID®

(Levothyroxine
Sodium Tablets, USP)

100 mcg
(0.1 mg)

Rx ONLY

100 TABLETS


Principal Display Panel - 112 Mcg (0.112 Mg)



jsp

NDC 60846-806-01

UNITHROID®

(Levothyroxine
Sodium Tablets, USP)

112 mcg
(0.112 mg)

Rx ONLY

100 TABLETS


Principal Display Panel - 125 Mcg (0.125 Mg)



jsp

NDC 60846-807-01

UNITHROID®

(Levothyroxine
Sodium Tablets, USP)

125 mcg
(0.125 mg)

Rx ONLY

100 TABLETS


Principal Display Panel - 137 Mcg (0.137 Mg)



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NDC 60846-808-01

UNITHROID®

(Levothyroxine
Sodium Tablets, USP)

137 mcg
(0.137 mg)

Rx ONLY

100 TABLETS


Principal Display Panel - 150 Mcg (0.15 Mg)



jsp

NDC 60846-809-01

UNITHROID®

(Levothyroxine
Sodium Tablets, USP)

150 mcg
(0.15 mg)

Rx ONLY

100 TABLETS


Principal Display Panel - 175 Mcg (0.175 Mg)



jsp

NDC 60846-810-01

UNITHROID®

(Levothyroxine
Sodium Tablets, USP)

175 mcg
(0.175 mg)

Rx ONLY

100 TABLETS


Principal Display Panel - 200 Mcg (0.2 Mg)



jsp

NDC 60846-811-01

UNITHROID®

(Levothyroxine
Sodium Tablets, USP)

200 mcg
(0.200 mg)

Rx ONLY

100 TABLETS


Principal Display Panel - 300 Mcg (0.3 Mg)



jsp

NDC 60846-812-01

UNITHROID®

(Levothyroxine
Sodium Tablets, USP)

300 mcg
(0.300 mg)

Rx ONLY

100 TABLETS


* Please review the disclaimer below.