NDC 0069-0228 Fragmin

Dalteparin Sodium Injection Subcutaneous - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
0069-0228
Proprietary Name:
Fragmin
Non-Proprietary Name: [1]
Dalteparin Sodium
Substance Name: [2]
Dalteparin 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]
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
  • Labeler Name: [5]
    Pfizer Laboratories Div Pfizer Inc
    Labeler Code:
    0069
    FDA Application Number: [6]
    NDA020287
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    04-01-2015
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 0069-0228-02

    Package Description: 10 SYRINGE in 1 CARTON / .72 mL in 1 SYRINGE (0069-0228-01)

    Product Details

    What is NDC 0069-0228?

    The NDC code 0069-0228 is assigned by the FDA to the product Fragmin which is a human prescription drug product labeled by Pfizer Laboratories Div Pfizer Inc. The generic name of Fragmin is dalteparin sodium. The product's dosage form is injection and is administered via subcutaneous form. The product is distributed in a single package with assigned NDC code 0069-0228-02 10 syringe in 1 carton / .72 ml in 1 syringe (0069-0228-01). 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 Fragmin?

    Dalteparin is used to treat and prevent harmful blood clots. Preventing harmful blood clots helps to reduce the risk of a stroke or heart attack. This medication helps keep your blood flowing smoothly by lowering the activity of clotting proteins in the blood. Dalteparin is a type of heparin, and works as an anticoagulant (commonly called a "blood thinner"). Conditions that increase your risk of developing blood clots include certain types of surgeries (such as hip replacement or abdominal surgery), long periods of being in one position (immobile), certain types of heart attack, and a certain type of chest pain called unstable angina. For some medical conditions, dalteparin may be used in combination with other "blood thinners." Dalteparin may also be used to treat and prevent clots from coming back in patients with cancer.

    What are Fragmin 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.
    • DALTEPARIN SODIUM 18000 [iU]/.72mL - A low-molecular-weight fragment of heparin, prepared by nitrous acid depolymerization of porcine mucosal heparin. The mean molecular weight is 4000-6000 daltons. It is used therapeutically as an antithrombotic agent. (From Merck Index, 11th ed)

    Which are Fragmin UNII Codes?

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

    Which are Fragmin 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 Fragmin?

    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 Fragmin?

    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

    Dalteparin Injection


    Dalteparin is used in combination with aspirin to prevent serious or life-threatening complications from angina (chest pain) and heart attacks. Dalteparin is also used to prevent deep vein thrombosis (DVT; a blood clot, usually in the leg), which can lead to pulmonary embolism (PE; a blood clot in the lung), in people who are on bedrest or who are having hip replacement or abdominal surgery. It is also used treat DVT or PE and prevent it from happening again in children one month of age and older, and in adults with DVT or PE who have cancer. Dalteparin 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".