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  4. NDC Product Code: 54868-5982 Dorzolamide Hydrochloride And Timolol Maleate

NDC 54868-5982 Dorzolamide Hydrochloride And Timolol Maleate

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 54868-5982?
  4. Dorzolamide Hydrochloride And Timolol Maleate Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
54868-5982
Proprietary Name:
Dorzolamide Hydrochloride And Timolol Maleate
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Physicians Total Care, Inc.
Labeler Code:
54868
Product Label ID:
3206f5f4-103f-4f04-9c95-35cf17e7a3eb
Start Marketing Date: [9]
02-04-2009
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
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Product Details

What is NDC 54868-5982?

The NDC code 54868-5982 is assigned by the FDA to the product Dorzolamide Hydrochloride And Timolol Maleate 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 54868-5982-0 1 bottle, dropper in 1 box / 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 Dorzolamide Hydrochloride And Timolol Maleate?

Dorzolamide Hydrochloride-Timolol Maleate Ophthalmic Solution is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers (failed to achieve target IOP determined after multiple measurements over time). The IOP-lowering of Dorzolamide Hydrochloride-Timolol Maleate Ophthalmic Solution b.i.d. was slightly less than seen with the concomitant administration of 0.5% timolol b.i.d. and 2.0% dorzolamide t.i.d. (see CLINICAL PHARMACOLOGY, Clinical Studies ).

Which are Dorzolamide Hydrochloride And Timolol Maleate UNII Codes?

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

Which are Dorzolamide Hydrochloride And Timolol Maleate 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 Dorzolamide Hydrochloride And Timolol Maleate?

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: 1923432 - dorzolamide HCl 2 % / timolol maleate 0.5 % Ophthalmic Solution
  • RxCUI: 1923432 - dorzolamide 20 MG/ML / timolol 5 MG/ML Ophthalmic Solution
  • RxCUI: 1923432 - dorzolamide 2 % / timolol 0.5 % Ophthalmic Solution
  • RxCUI: 1923432 - dorzolamide 20 MG/ML (as dorzolamide HCl 22.26 MG/ML) / timolol 5 MG/ML (as timolol maleate 6.83 MG/ML) Ophthalmic Solution

* 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".