NDC 0023-5301 Restasis Multidose
Cyclosporine Emulsion Ophthalmic

Table of Contents

    1. Product Information
    2. Product Packages
    3. What is NDC 0023-5301?
    4. Restasis Multidose Uses
    5. Active Ingredients
    6. Active Ingredients UNII Codes
    7. Inactive Ingredients UNII Codes
    8. NDC to RxNorm Crosswalk
    9. Pharmacologic Classes
    10. Patient Education

Product Information

NDC Product Code0023-5301
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.		Restasis Multidose
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.		Cyclosporine
Substance Name What is the Substance Name?
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.		Cyclosporine
Product Type What kind of product is this?
Indicates 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.		Human Prescription Drug
NDC Directory StatusACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage FormEmulsion - A dosage form consisting of a two-phase system comprised of at least two immiscible liquids1, one of which is dispersed as droplets (internal or dispersed phase) within the other liquid (external or continuous phase), generally stabilized with one or more emulsifying agents. (Note: Emulsion is used as a dosage form term unless a more specific term is applicable, e.g. cream, lotion, ointment.)
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Ophthalmic - Administration to the external eye.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		Allergan, Inc.
Labeler Code0023
SPL SET ID:7224d810-bb96-4682-a942-3355e6e8061a
FDA Application Number What is the FDA Application Number?
This 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.		NDA050790
Marketing Category What is the Marketing Category?
Product 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.		NDA - A product marketed under an approved New Drug Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.		11-10-2016
Listing Expiration Date 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.		12-31-2024
Exclude Flag 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". 		N
NDC Code Structure

Product Packages

NDC Code 0023-5301-05

Package Description: 1 BOTTLE in 1 CARTON / 5.5 mL in 1 BOTTLE

Price per Unit: $112.39653 per ML

NDC Code 0023-5301-08

Package Description: 1 BOTTLE in 1 CARTON / 5.5 mL in 1 BOTTLE

Product Details

What is NDC 0023-5301?

The NDC code 0023-5301 is assigned by the FDA to the product Restasis Multidose which is a human prescription drug product labeled by Allergan, Inc.. The generic name of Restasis Multidose is cyclosporine. The product's dosage form is emulsion and is administered via ophthalmic form. The product is distributed in 2 packages with assigned NDC codes 0023-5301-05 1 bottle in 1 carton / 5.5 ml in 1 bottle, 0023-5301-08 1 bottle in 1 carton / 5.5 ml in 1 bottle. 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 Restasis Multidose?

Cyclosporine eye drops are used to treat a certain type of dry eyes. They work by increasing the amount of tears you make.

What are Restasis Multidose Active Ingredients?

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.
  • CYCLOSPORINE .5 mg/mL - A cyclic undecapeptide from an extract of soil fungi. It is a powerful immunosupressant with a specific action on T-lymphocytes. It is used for the prophylaxis of graft rejection in organ and tissue transplantation. (From Martindale, The Extra Pharmacopoeia, 30th ed).

Which are Restasis Multidose UNII Codes?

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

Which are Restasis Multidose 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 Restasis Multidose?

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:

Which are the Pharmacologic Classes for Restasis Multidose?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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Patient Education

Cyclosporine Ophthalmic


Ophthalmic cyclosporine is used to increase tear production in people with dry eye disease. Cyclosporine is in a class of medications called immunomodulators. It works by decreasing swelling in the eye to allow for tear production.
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Product Label

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