NDC 67457-385 Heparin Sodium

Injection Intravenous; Subcutaneous - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
67457-385
Proprietary Name:
Heparin Sodium
Non-Proprietary Name: [1]
Heparin Sodium
Substance Name: [2]
Heparin Sodium
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route(s): [4]
  • Intravenous - Administration within or into a vein or veins.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
  • Labeler Code:
    67457
    FDA Application Number: [6]
    ANDA203851
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    03-16-2018
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
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    Product Details

    What is NDC 67457-385?

    The NDC code 67457-385 is assigned by the FDA to the product Heparin Sodium which is a human prescription drug product labeled by Mylan Institutional Llc. The product's dosage form is injection and is administered via intravenous; subcutaneous form. The product is distributed in a single package with assigned NDC code 67457-385-99 25 vial, multi-dose in 1 carton / 10 ml in 1 vial, multi-dose (67457-385-10). 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 Heparin Sodium?

    This medication is used to prevent and treat blood clots. It may be used to prevent and treat blood clots in the lungs/legs (including in patients with atrial fibrillation). It may be used to treat certain blood clotting disorders. It may also be used to prevent blood clots after surgery, during dialysis, during blood transfusions, when collecting blood samples, or when a person is unable to move for a long time. Heparin helps to keep blood flowing smoothly by making a certain natural substance in your body (anti-clotting protein) work better. It is known as an anticoagulant.

    What are Heparin Sodium 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.
    • HEPARIN SODIUM 1000 [USP'U]/mL - A highly acidic mucopolysaccharide formed of equal parts of sulfated D-glucosamine and D-glucuronic acid with sulfaminic bridges. The molecular weight ranges from six to twenty thousand. Heparin occurs in and is obtained from liver, lung, mast cells, etc., of vertebrates. Its function is unknown, but it is used to prevent blood clotting in vivo and vitro, in the form of many different salts.

    Which are Heparin Sodium UNII Codes?

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

    Which are Heparin Sodium 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 Heparin Sodium?

    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:
    • RxCUI: 1361226 - heparin sodium, porcine 1000 UNT/ML Injectable Solution
    • RxCUI: 1361615 - heparin sodium, porcine 5000 UNT/ML Injectable Solution
    • RxCUI: 1362831 - heparin sodium, porcine 10,000 UNT/ML Injectable Solution
    • RxCUI: 1362831 - heparin sodium, porcine 10000 UNT/ML Injectable Solution

    Which are the Pharmacologic Classes for Heparin Sodium?

    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

    Heparin Injection


    Heparin is used to prevent blood clots from forming in people who have certain medical conditions or who are undergoing certain medical procedures that increase the chance that clots will form. Heparin is also used to stop the growth of clots that have already formed in the blood vessels, but it cannot be used to decrease the size of clots that have already formed. Heparin is also used in small amounts to prevent blood clots from forming in catheters (small plastic tubes through which medication can be administered or blood drawn) that are left in veins over a period of time. Heparin is in a class of medications called anticoagulants ('blood thinners'). It works by decreasing the clotting ability of the blood.
    [Learn More]


    Blood Thinners


    What are blood thinners?

    Blood thinners are medicines that prevent blood clots from forming. They do not break up clots that you already have. But they can stop those clots from getting bigger. It's important to treat blood clots, because clots in your blood vessels and heart can cause heart attacks, strokes, and blockages.

    Who needs blood thinners?

    You may need a blood thinner if you have:

    What are the different types of blood thinners?

    There are different types of blood thinners:

    • Anticoagulants, such as heparin or warfarin (also called Coumadin), slow down your body's process of making clots.
    • Antiplatelets, such as aspirin and clopidogrel, prevent blood cells called platelets from clumping together to form a clot. Antiplatelets are mainly taken by people who have had a heart attack or stroke.

    How can I take blood thinners safely?

    When you take a blood thinner, follow the directions carefully. Blood thinners may interact with certain foods, medicines, vitamins, and alcohol. Make sure that your health care provider knows all of the medicines and supplements you are using.

    You may need regular blood tests to check how well your blood is clotting. It is important to make sure that you're taking enough medicine to prevent clots, but not so much that it causes bleeding.

    What are the side effects of blood thinners?

    Bleeding is the most common side effect of blood thinners. They can also cause an upset stomach, nausea, and diarrhea.

    Other possible side effects can depend on which type of blood thinner that you are taking.

    Call your provider if you have any sign of serious bleeding, such as:

    • Menstrual bleeding that is much heavier than normal
    • Red or brown urine
    • Bowel movements that are red or black
    • Bleeding from the gums or nose that does not stop quickly
    • Vomit that is brown or bright red
    • Coughing up something red
    • Severe pain, such as a headache or stomachache
    • Unusual bruising
    • A cut that does not stop bleeding
    • A serious fall or bump on the head
    • Dizziness or weakness

    [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".