NDC 0065-4147 Simbrinza

Brinzolamide/brimonidine Tartrate Suspension/ Drops Ophthalmic - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
0065-4147
Proprietary Name:
Simbrinza
Non-Proprietary Name: [1]
Brinzolamide/brimonidine Tartrate
Substance Name: [2]
Brimonidine Tartrate; Brinzolamide
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Suspension/ Drops - A suspension which is usually administered in a dropwise fashion.
Administration Route(s): [4]
  • Ophthalmic - Administration to the external eye.
  • Labeler Name: [5]
    Alcon Laboratories, Inc.
    Labeler Code:
    0065
    FDA Application Number: [6]
    NDA204251
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    05-06-2013
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 0065-4147-25

    Package Description: 1 BOTTLE, DROPPER in 1 CARTON / 2.5 mL in 1 BOTTLE, DROPPER

    NDC Code 0065-4147-27

    Package Description: 1 BOTTLE, DROPPER in 1 CARTON / 8 mL in 1 BOTTLE, DROPPER

    Price per Unit: $24.81995 per ML

    Product Details

    What is NDC 0065-4147?

    The NDC code 0065-4147 is assigned by the FDA to the product Simbrinza which is a human prescription drug product labeled by Alcon Laboratories, Inc.. The generic name of Simbrinza is brinzolamide/brimonidine tartrate. The product's dosage form is suspension/ drops and is administered via ophthalmic form. The product is distributed in 2 packages with assigned NDC codes 0065-4147-25 1 bottle, dropper in 1 carton / 2.5 ml in 1 bottle, dropper, 0065-4147-27 1 bottle, dropper in 1 carton / 8 ml in 1 bottle, dropper. 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 Simbrinza?

    This product contains two medications used to treat high pressure in the eye due to glaucoma (open-angle glaucoma-type) or a certain other eye disease (ocular hypertension). Lowering high pressure in the eye reduces the risk of vision loss, nerve damage, or blindness. This product contains brinzolamide and brimonidine. These two medications work together to decrease the amount of fluid within the eye. Brinzolamide belongs to a class of drugs known as carbonic anhydrase inhibitors. Brimonidine belongs to a class of drugs known as alpha agonists. This product is not recommended for use in children younger than 2 years of age due to an increased risk of serious side effects such as very slowed breathing. Ask the doctor or pharmacist for details.

    What are Simbrinza 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.

    Which are Simbrinza UNII Codes?

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

    Which are Simbrinza 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 Simbrinza?

    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: 1421451 - brinzolamide 1 % / brimonidine tartrate 0.2 % Ophthalmic Suspension
    • RxCUI: 1421451 - brimonidine tartrate 2 MG/ML / brinzolamide 10 MG/ML Ophthalmic Suspension
    • RxCUI: 1421451 - brimonidine tartrate 0.2 % / brinzolamide 1 % Ophthalmic Suspension
    • RxCUI: 1421456 - SIMBRINZA 1 % / 0.2 % Ophthalmic Suspension
    • RxCUI: 1421456 - brimonidine tartrate 2 MG/ML / brinzolamide 10 MG/ML Ophthalmic Suspension [Simbrinza]

    Which are the Pharmacologic Classes for Simbrinza?

    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

    Brimonidine Ophthalmic


    Ophthalmic brimonidine is used to lower pressure in the eyes in patients who have glaucoma (high pressure in the eyes that may damage nerves and cause vision loss) and ocular hypertension (pressure in the eyes that is higher than normal but not high enough to cause vision loss). Brimonidine is in a class of drugs called alpha adrenergic agonists. Brimonidine works by decreasing the amount of fluid in the eyes.
    [Learn More]


    Brinzolamide Ophthalmic


    Ophthalmic Brinzolamide is used to treat glaucoma, a condition that increases pressure in the eye and leads to vision loss. Brinzolamide is in a class of medications called carbonic anhydrase inhibitors. It decreases the pressure in the eye.
    [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".