NDC 0023-9211 Combigan

Brimonidine Tartrate,Timolol Maleate Solution/ Drops Ophthalmic - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
0023-9211
Proprietary Name:
Combigan
Non-Proprietary Name: [1]
Brimonidine Tartrate, Timolol Maleate
Substance Name: [2]
Brimonidine Tartrate; Timolol Maleate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Solution/ Drops - A solution which is usually administered in a drop-wise fashion.
Administration Route(s): [4]
  • Ophthalmic - Administration to the external eye.
  • Labeler Name: [5]
    Allergan, Inc.
    Labeler Code:
    0023
    FDA Application Number: [6]
    NDA021398
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    11-14-2007
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Packages

    NDC Code 0023-9211-03

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

    NDC Code 0023-9211-05

    Package Description: 1 BOTTLE, DROPPER in 1 CARTON / 5 mL in 1 BOTTLE, DROPPER

    Price per Unit: $39.07786 per ML

    NDC Code 0023-9211-10

    Package Description: 1 BOTTLE, DROPPER in 1 CARTON / 10 mL in 1 BOTTLE, DROPPER

    Price per Unit: $39.10500 per ML

    NDC Code 0023-9211-15

    Package Description: 1 BOTTLE, DROPPER in 1 CARTON / 15 mL in 1 BOTTLE, DROPPER

    Price per Unit: $39.29491 per ML

    Product Details

    What is NDC 0023-9211?

    The NDC code 0023-9211 is assigned by the FDA to the product Combigan which is a human prescription drug product labeled by Allergan, Inc.. The generic name of Combigan is brimonidine tartrate, timolol maleate. The product's dosage form is solution/ drops and is administered via ophthalmic form. The product is distributed in 4 packages with assigned NDC codes 0023-9211-03 1 bottle, dropper in 1 carton / 2.5 ml in 1 bottle, dropper, 0023-9211-05 1 bottle, dropper in 1 carton / 5 ml in 1 bottle, dropper, 0023-9211-10 1 bottle, dropper in 1 carton / 10 ml in 1 bottle, dropper, 0023-9211-15 1 bottle, dropper in 1 carton / 15 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 Combigan?

    This combination medication is used to treat high pressure inside the eye due to glaucoma (open-angle type) or other eye diseases (e.g., ocular hypertension). Lowering high pressure inside the eye helps to prevent blindness. This product contains brimonidine and timolol. These medications are used together when 1 drug is not controlling the pressure inside the eye. Brimonidine works by allowing better fluid drainage from within the eye and also by decreasing the amount of fluid formed in the eye. It belongs to a class of drugs known as alpha agonists. Timolol is thought to work by decreasing the amount of fluid formed in the eye. Timolol belongs to a class of drugs known as beta blockers. This medication is not recommended for use in children less than 2 years old due to an increased risk of serious side effects. Ask the doctor or pharmacist for more details.

    What are Combigan 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.
    • BRIMONIDINE TARTRATE 2 mg/mL - A quinoxaline derivative and ADRENERGIC ALHPA-2 RECEPTOR AGONIST that is used to manage INTRAOCULAR PRESSURE associated with OPEN-ANGLE GLAUCOMA and OCULAR HYPERTENSION.
    • TIMOLOL MALEATE 5 mg/mL - A beta-adrenergic antagonist that is similar in action to PROPRANOLOL; the levo-isomer is more active. Timolol has been proposed as an anti-hypertensive, anti-arrhythmic, anti-angina, and anti-glaucoma agent. It is also used in the treatment of MIGRAINE DISORDERS and tremor.

    Which are Combigan UNII Codes?

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

    Which are Combigan 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 Combigan?

    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: 861635 - brimonidine tartrate 0.2 % / timolol maleate 0.5 % Ophthalmic Solution
    • RxCUI: 861635 - brimonidine tartrate 2 MG/ML / timolol 5 MG/ML Ophthalmic Solution
    • RxCUI: 861635 - brimonidine tartrate 0.2 % / timolol 0.5 % Ophthalmic Solution
    • RxCUI: 861637 - Combigan 0.2 % / 0.5 % Ophthalmic Solution
    • RxCUI: 861637 - brimonidine tartrate 2 MG/ML / timolol 5 MG/ML Ophthalmic Solution [Combigan]

    Which are the Pharmacologic Classes for Combigan?

    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]


    Timolol Ophthalmic


    Ophthalmic timolol is used to treat glaucoma, a condition in which increased pressure in the eye can lead to gradual loss of vision. Timolol is in a class of medications called beta-blockers. It works by decreasing 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".