NDC 0023-9321 Alphagan P
Brimonidine Tartrate Solution/ Drops Ophthalmic

Table of Contents

    1. Product Information
    2. Product Packages
    3. What is NDC 0023-9321?
    4. Alphagan P Uses
    5. Active Ingredients
    6. Active Ingredients UNII Codes
    7. Inactive Ingredients UNII Codes
    8. NDC to RxNorm Crosswalk
    9. Pharmacologic Classes
    10. Patient Education

Product Information

NDC Product Code0023-9321
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.		Alphagan P
Non-Proprietary Name 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.		Brimonidine Tartrate
Substance Name 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.		Brimonidine Tartrate
Product Type 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.		Human Prescription Drug
NDC Directory StatusACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage FormSolution/ Drops - A solution which is usually administered in a drop-wise fashion.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Ophthalmic - Administration to the external eye.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		Allergan, Inc.
Labeler Code0023
SPL SET ID:264c4494-c225-486f-888a-caaf36be46b3
FDA Application Number 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.		NDA021770
Marketing Category 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.		NDA - A product marketed under an approved New Drug Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.		01-25-2006
Listing Expiration Date 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.		12-31-2023
Exclude Flag 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". 		N
NDC Code Structure

Product Packages

NDC Code 0023-9321-03

Package Description: 1 BOTTLE, DROPPER in 1 CARTON / 3 mL in 1 BOTTLE, DROPPER

NDC Code 0023-9321-05

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

Price per Unit: $37.32115 per ML

NDC Code 0023-9321-10

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

Price per Unit: $37.20658 per ML

NDC Code 0023-9321-15

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

Price per Unit: $37.34485 per ML

Product Details

What is NDC 0023-9321?

The NDC code 0023-9321 is assigned by the FDA to the product Alphagan P which is a human prescription drug product labeled by Allergan, Inc.. The generic name of Alphagan P is brimonidine tartrate. 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 0023-9321-03 1 bottle, dropper in 1 carton / 3 ml in 1 bottle, dropper, 0023-9321-05 1 bottle, dropper in 1 carton / 5 ml in 1 bottle, dropper, 0023-9321-10 1 bottle, dropper in 1 carton / 10 ml in 1 bottle, dropper, 0023-9321-15 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 Alphagan P?

This medication is used to treat open-angle glaucoma or high fluid pressure in the eye. Lowering high fluid pressure in the eye reduces the risk of vision loss, nerve damage, or blindness. This medication lowers pressure by allowing better fluid drainage from within the eye and also by reducing the amount of fluid formed in the eye. It is known as an alpha agonist. This drug is not recommended for use in children less 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 Alphagan P 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 1 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.

Which are Alphagan P UNII Codes?

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

Which are Alphagan P 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 Alphagan P?

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 Alphagan P?

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.

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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.
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