Combigan
NDC Package 54868-6295-0
Package Information
Combigan is 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). Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-6295 and is authorized under FDA application NDA021398.
Identification & Billing
- 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 % (as timolol maleate 6.8 MG/ML) 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]
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 54868 - Physicians Total Care, Inc.
- 54868-6295 - Combigan
- 54868-6295-0 - 1 BOTTLE, DROPPER in 1 CARTON / 10 mL in 1 BOTTLE, DROPPER
- 54868-6295 - Combigan
The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.
* Please review the full disclaimer at the bottom of this page.
Frequently Asked Questions
What is the distribution configuration for this product package?
The code 54868-6295-0 identifies a specific commercial package of 1 bottle, dropper in 1 carton / 10 ml in 1 bottle, dropper of Combigan, labeled by Physicians Total Care, Inc.. This is formulated for use and contains as the active substance.
Is this product currently listed with the FDA?
This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Physicians Total Care, Inc. on August 29, 2011. The current certification is valid through December 31, 2017.
What are the primary indications for this medication?
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.
How is this Physicians Total Care, Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868629500. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.
11-Digit Code Conversion
Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:
Note: The zero is added to the Package segment to maintain the 5-4-2 structure.
