NDC 0074-7069 Synthroid

Levothyroxine Sodium Tablet Oral - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
0074-7069
Proprietary Name:
Synthroid
Non-Proprietary Name: [1]
Levothyroxine Sodium
Substance Name: [2]
Levothyroxine Sodium
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
  • Labeler Name: [5]
    Abbvie Inc.
    Labeler Code:
    0074
    FDA Application Number: [6]
    NDA021402
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    07-24-2002
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Color(s):
    GREEN (C48329)
    ORANGE (C48331)
    WHITE (C48325)
    PURPLE (C48327 - VIOLET)
    YELLOW (C48330)
    GREEN (C48329 - OLIVE)
    RED (C48326 - ROSE)
    BROWN (C48332)
    BLUE (C48333 - TURQUOISE)
    BLUE (C48333)
    Shape:
    ROUND (C48348)
    Size(s):
    7 MM
    Imprint(s):
    SYNTHROID;300
    SYNTHROID;25
    SYNTHROID;50
    SYNTHROID;75
    SYNTHROID;100
    SYNTHROID;88
    SYNTHROID;112
    SYNTHROID;125
    SYNTHROID;137
    SYNTHROID;150
    Score:
    2

    Product Packages

    NDC Code 0074-7069-11

    Package Description: 10 BLISTER PACK in 1 BOX, UNIT-DOSE / 10 TABLET in 1 BLISTER PACK

    Price per Unit: $1.51140 per EA

    NDC Code 0074-7069-19

    Package Description: 1000 TABLET in 1 BOTTLE

    Price per Unit: $1.51140 per EA

    NDC Code 0074-7069-72

    Package Description: 2 BLISTER PACK in 1 CARTON / 7 TABLET in 1 BLISTER PACK

    NDC Code 0074-7069-90

    Package Description: 90 TABLET in 1 BOTTLE

    Price per Unit: $1.51140 per EA

    Product Details

    What is NDC 0074-7069?

    The NDC code 0074-7069 is assigned by the FDA to the product Synthroid which is a human prescription drug product labeled by Abbvie Inc.. The generic name of Synthroid is levothyroxine sodium. The product's dosage form is tablet and is administered via oral form. The product is distributed in 4 packages with assigned NDC codes 0074-7069-11 10 blister pack in 1 box, unit-dose / 10 tablet in 1 blister pack, 0074-7069-19 1000 tablet in 1 bottle , 0074-7069-72 2 blister pack in 1 carton / 7 tablet in 1 blister pack, 0074-7069-90 90 tablet in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Synthroid?

    Levothyroxine is used to treat an underactive thyroid (hypothyroidism). It replaces or provides more thyroid hormone, which is normally produced by the thyroid gland. Low thyroid hormone levels can occur naturally or when the thyroid gland is injured by radiation/medications or removed by surgery. Having enough thyroid hormone is important for maintaining normal mental and physical activity. In children, having enough thyroid hormone is important for normal mental and physical development. This medication is also used to treat other types of thyroid disorders (such as certain types of goiters, thyroid cancer). This medication should not be used to treat infertility unless it is caused by low thyroid hormone levels.

    What are Synthroid Active Ingredients?

    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.
    • LEVOTHYROXINE SODIUM 150 ug/1 - The major hormone derived from the thyroid gland. Thyroxine is synthesized via the iodination of tyrosines (MONOIODOTYROSINE) and the coupling of iodotyrosines (DIIODOTYROSINE) in the THYROGLOBULIN. Thyroxine is released from thyroglobulin by proteolysis and secreted into the blood. Thyroxine is peripherally deiodinated to form TRIIODOTHYRONINE which exerts a broad spectrum of stimulatory effects on cell metabolism.

    Which are Synthroid UNII Codes?

    The UNII codes for the active ingredients in this product are:

    Which are Synthroid Inactive Ingredients UNII Codes?

    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. The UNII codes for the inactive ingredients in this product are:

    What is the NDC to RxNorm Crosswalk for Synthroid?

    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:

    Which are the Pharmacologic Classes for Synthroid?

    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 used to treat hypothyroidism (condition where the thyroid gland does not produce enough thyroid hormone). It is also used with surgery and radioactive iodine therapy to treat thyroid cancer. Levothyroxine is in a class of medications called hormones. It works by replacing thyroid hormone that is normally produced by the body. Without thyroid hormone, your body cannot function properly, which may result in poor growth, slow speech, lack of energy, excessive tiredness, constipation, weight gain, hair loss, dry, thick skin, increased sensitivity to cold, joint and muscle pain, heavy or irregular menstrual periods, and depression. When taken correctly, levothyroxine reverses these symptoms.
    [Learn More]


    * Please review the disclaimer below.

    Product Footnotes

    [1] 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.

    [2] What is the Substance Name? - 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.

    [3] 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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] 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.

    [8] 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.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] 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] 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".