0536-0901 NDC - EYE IRRIGATING (PURIFIED WATER)

Drug Information

Product NDC: 0536-0901

Proprietary Name: Eye Irrigating

Non Proprietary Name: Purified Water

Active Ingredient(s):
  • 99.05 mL/100mL WATER


Administration Route(s): OPHTHALMIC

Dosage Form(s): SOLUTION

Labeler Information

Labeler Name: Rugby Laboratories Inc.
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED DRUG OTHER
Start Marketing Date:10/7/2011

Package Information

No. Package Code Package Description Billing Unit
10536-0901-97118 mL in 1 BOTTLE (0536-0901-97)ML

NDC Record

Field Name Field Value Definition
PRODUCT NDC0536-0901The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN OTC DRUGIndicates 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.
PROPRIETARY NAMEEye IrrigatingThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEPurified WaterThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMESOLUTIONThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEOPHTHALMICThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE10/7/2011This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEUNAPPROVED DRUG OTHERProduct 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.
LABELER NAMERugby Laboratories Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEWATERThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH99.05 
ACTIVE INGRED UNITmL/100mL 

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This page was last updated on: 10/2/2018