NDC 21695-203 Tobradex

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:
21695-203
Proprietary Name:
Tobradex
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Code:
21695
Start Marketing Date: [9]
08-18-1988
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
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Product Details

What is NDC 21695-203?

The NDC code 21695-203 is assigned by the FDA to the product Tobradex which is product labeled by Rebel Distributors Corp. The product's dosage form is . The product is distributed in a single package with assigned NDC code 21695-203-05 5 ml in 1 bottle, plastic . 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 Tobradex?

This medication is used to treat or prevent eye infections. This medication contains two drugs. Tobramycin belongs to a class of drugs called aminoglycoside antibiotics. It works by stopping the growth of bacteria. Dexamethasone belongs to a class of drugs called corticosteroids. It works by reducing swelling. This medication treats/prevents only bacterial eye infections. It will not work for other types of eye infections. Unnecessary use or overuse of any antibiotic can lead to its decreased effectiveness.

Which are Tobradex UNII Codes?

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

Which are Tobradex 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 Tobradex?

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: 208813 - TobraDex 0.3 % / 0.1 % Ophthalmic Suspension
  • RxCUI: 208813 - dexamethasone 1 MG/ML / tobramycin 3 MG/ML Ophthalmic Suspension [Tobradex]
  • RxCUI: 208813 - TobraDex (dexamethasone 0.1 % / tobramycin 0.3 % ) Ophthalmic Suspension
  • RxCUI: 309683 - tobramycin 0.3 % / dexAMETHasone 0.1 % Ophthalmic Suspension
  • RxCUI: 309683 - dexamethasone 1 MG/ML / tobramycin 3 MG/ML Ophthalmic Suspension

* 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".