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Drug Information

Product NDC: 0023-9163

Proprietary Name: RESTASIS

Non Proprietary Name: cyclosporine

Active Ingredient(s):

Administration Route(s): OPHTHALMIC

Dosage Form(s): EMULSION

Pharmacy Class(es):
  • Calcineurin Inhibitor Immunosuppressant [EPC];
  • Calcineurin Inhibitors [MoA];
  • Cytochrome P450 3A4 Inhibitors [MoA];
  • P-Glycoprotein Inhibitors [MoA]

Labeler Information

Labeler Name: Allergan, Inc.
FDA Application Number: NDA050790
Marketing Category: NDA
Start Marketing Date:4/1/2003

Package Information

No. Package Code Package Description Billing Unit
10023-9163-125 VIAL, SINGLE-USE in 1 CARTON (0023-9163-12) / .4 mL in 1 VIAL, SINGLE-USE
20023-9163-3030 VIAL, SINGLE-USE in 1 TRAY (0023-9163-30) / .4 mL in 1 VIAL, SINGLE-USEEA
30023-9163-6060 VIAL, SINGLE-USE in 1 TRAY (0023-9163-60) / .4 mL in 1 VIAL, SINGLE-USEEA

NDC Record

Field Name Field Value Definition
PRODUCT NDC0023-9163The 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 PRESCRIPTION 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 NAMERESTASISThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEcyclosporineThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEEMULSIONThe 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 DATE4/1/2003This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMENDAProduct 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 NUMBERNDA050790This 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 NAMEAllergan, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMECYCLOSPORINEAn 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 CLASSESCalcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA] 

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