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Drug Information

Product NDC: 0536-1282

Proprietary Name: Lubricating Eye Drops

Non Proprietary Name: dextran 70 and hypromellose 2910

Active Ingredient(s):
  • 1 mg/mL DEXTRAN 70;
  • 3 mg/mL HYPROMELLOSE 2910 (4000 MPA.S)

Administration Route(s): OPHTHALMIC

Dosage Form(s): SOLUTION/ DROPS

Pharmacy Class(es):
  • Increased Intravascular Volume [PE];
  • Osmotic Activity [MoA];
  • Plasma Volume Expander [EPC]

Labeler Information

Labeler Name: Rugby Laboratories
Product Type: HUMAN OTC DRUG
FDA Application Number: part349
Marketing Category: OTC MONOGRAPH FINAL
Start Marketing Date:1/22/2020

Package Information

No. Package Code Package Description Billing Unit
10536-1282-941 BOTTLE, DROPPER in 1 CARTON (0536-1282-94) / 15 mL in 1 BOTTLE, DROPPERML

NDC Record

Field Name Field Value Definition
PRODUCT NDC0536-1282The 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 NAMELubricating Eye DropsThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEdextran 70 and hypromellose 2910The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMESOLUTION/ DROPSThe 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 DATE1/22/2020This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEOTC MONOGRAPH FINALProduct 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 under Structured Product Labeling Resources.
APPLICATION NUMBERpart349This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMERugby LaboratoriesName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEDEXTRAN 70; HYPROMELLOSE 2910 (4000 MPA.S)An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
PHARM CLASSESIncreased Intravascular Volume [PE], Osmotic Activity [MoA], Plasma Volume Expander [EPC] 

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This page was last updated on: 2/1/2023