NDC 54868-6295 Combigan

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
54868-6295
Proprietary Name:
Combigan
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Code:
54868
Start Marketing Date: [9]
08-29-2011
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
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Product Details

What is NDC 54868-6295?

The NDC code 54868-6295 is assigned by the FDA to the product Combigan which is product labeled by Physicians Total Care, Inc.. The product's dosage form is . The product is distributed in a single package with assigned NDC code 54868-6295-0 1 bottle, dropper in 1 carton / 10 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.

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]

* Please review the disclaimer below.

Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[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".