NDC 0781-6135 Penicillin G Potassium

Injection, Powder, For Solution Intramuscular; Intravenous - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
0781-6135
Proprietary Name:
Penicillin G Potassium
Non-Proprietary Name: [1]
Penicillin G Potassium
Substance Name: [2]
Penicillin G Potassium
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Injection, Powder, For Solution - A sterile preparation intended for reconstitution to form a solution for parenteral use.
Administration Route(s): [4]
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
  • Labeler Name: [5]
    Sandoz Inc
    Labeler Code:
    0781
    FDA Application Number: [6]
    ANDA065079
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    08-30-2001
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 0781-6135-95

    Package Description: 10 VIAL in 1 CARTON / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0781-6135-94)

    Product Details

    What is NDC 0781-6135?

    The NDC code 0781-6135 is assigned by the FDA to the product Penicillin G Potassium which is a human prescription drug product labeled by Sandoz Inc. The product's dosage form is injection, powder, for solution and is administered via intramuscular; intravenous form. The product is distributed in a single package with assigned NDC code 0781-6135-95 10 vial in 1 carton / 1 injection, powder, for solution in 1 vial (0781-6135-94). 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 Penicillin G Potassium?

    This medication is used to treat a wide variety of bacterial infections. It is also used to prevent infection of the heart (bacterial endocarditis) in patients with certain heart diseases who are having surgery. This medication is known as a natural penicillin antibiotic. It works by stopping the growth of bacteria.

    What are Penicillin G Potassium 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.
    • PENICILLIN G POTASSIUM 5000000 [iU]/1 - A penicillin derivative commonly used in the form of its sodium or potassium salts in the treatment of a variety of infections. It is effective against most gram-positive bacteria and against gram-negative cocci. It has also been used as an experimental convulsant because of its actions on GAMMA-AMINOBUTYRIC ACID mediated synaptic transmission.

    Which are Penicillin G Potassium UNII Codes?

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

    Which are Penicillin G Potassium 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 Penicillin G Potassium?

    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: 863538 - penicillin G potassium 1,000,000 UNT/ML Injectable Solution
    • RxCUI: 863538 - penicillin G potassium 1000000 UNT/ML Injectable Solution
    • RxCUI: 863538 - Penicillin G K+ 1000000 UNT/ML Injectable Solution
    • RxCUI: 863538 - Penicillin G Pot 1000000 UNT/ML Injectable Solution
    • RxCUI: 863538 - penicillin G potassium 20,000,000 UNT per 11.5 ML Injectable Solution

    Which are the Pharmacologic Classes for Penicillin G Potassium?

    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

    Penicillin G (Potassium, Sodium) Injection


    Penicillin G injection is used to treat and prevent certain infections caused by bacteria. Penicillin G injection is in a class of medications called penicillins. It works by killing bacteria that cause infections. Antibiotics such as penicillin G injection will not work for colds, flu, or other viral infections. Taking antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.
    [Learn More]


    Penicillin G Benzathine Injection


    Penicillin G benzathine injection is used to treat and prevent certain infections caused by bacteria. Penicillin G benzathine injection is in a class of antibiotics called penicillins. It works by killing bacteria that cause infections. Antibiotics such as penicillin G benzathine injection will not work for colds, flu, or other viral infections. Taking antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.
    [Learn More]


    Penicillin G Benzathine and Penicillin G Procaine Injection


    Penicillin G benzathine and penicillin G procaine injection is used to treat and prevent certain infections caused by bacteria. Penicillin G benzathine and penicillin G procaine injection should not be used to treat sexually transmitted diseases (STD) or early in the treatment of certain serious infections. Penicillin G benzathine and penicillin G procaine injection is in a class of medications called penicillins. It works by killing bacteria that cause infections. Antibiotics such as penicillin G benzathine and penicillin G procaine injection will not work for colds, flu, or other viral infections. Taking antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.
    [Learn More]


    Penicillin G Procaine Injection


    Penicillin G procaine injection is used to treat certain infections caused by bacteria. Penicillin G procaine injection should not be used to treat gonorrhea (a sexually transmitted disease) or early in the treatment of certain serious infections. Penicillin G procaine injection is in a class of medications called penicillins. It works by killing bacteria that cause infections. Antibiotics such as penicillin G procaine injection will not work for colds, flu, or other viral infections. Taking antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.
    [Learn More]


    Antibiotics


    What are antibiotics?

    Antibiotics are medicines that fight bacterial infections in people and animals. They work by killing the bacteria or by making it hard for the bacteria to grow and multiply.

    Antibiotics can be taken in different ways:

    • Orally (by mouth). This could be pills, capsules, or liquids.
    • Topically. This might be a cream, spray, or ointment that you put on your skin. It could also be eye ointment, eye drops, or ear drops.
    • Through an injection or intravenously (IV). This is usually for more serious infections.

    What do antibiotics treat?

    Antibiotics only treat certain bacterial infections, such as strep throat, urinary tract infections, and E. coli.

    You may not need to take antibiotics for some bacterial infections. For example, you might not need them for many sinus infections or some ear infections. Taking antibiotics when they're not needed won't help you, and they can have side effects. Your health care provider can decide the best treatment for you when you're sick. Don't ask your provider to prescribe an antibiotic for you.

    Do antibiotics treat viral infections?

    Antibiotics do not work on viral infections. For example, you shouldn't take antibiotics for:

    What are the side effects of antibiotics?

    The side effects of antibiotics range from minor to very severe. Some of the common side effects include:

    More serious side effects can include:

    Call your health care provider if you develop any side effects while taking your antibiotic.

    Why is it important to take antibiotics only when they're needed?

    You should only take antibiotics when they are needed because they can cause side effects and can contribute to antibiotic resistance. Antibiotic resistance happens when the bacteria change and become able to resist the effects of an antibiotic. This means that the bacteria continue to grow.

    How do I use antibiotics correctly?

    When you take antibiotics, it is important that you take them responsibly:

    • Always follow the directions carefully. Finish your medicine even if you feel better. If you stop taking them too soon, some bacteria may survive and re-infect you.
    • Don't save your antibiotics for later.
    • Don't share your antibiotic with others.
    • Don't take antibiotics prescribed for someone else. This may delay the best treatment for you, make you even sicker, or cause side effects.

    Centers for Disease Control and Prevention


    [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".