RESTASIS

Orange BookUNIISPLATC S01XA18

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerA-S Medication Solutions

CountryUS (United States)

ATC codeS01XA18

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5009044760
30 VIAL, SINGLE-USE in 1 TRAY (50090-4476-0) / .4 mL in 1 VIAL, SINGLE-USE

Annotations

UNII (FDA Substance ID)

83HN0GTJ6D

CYCLOSPORINE

RxCUI 3008

Orange Book

N050790

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "83HN0GTJ6D",
    "rxcui": "3008",
    "inchikey": "PMATZTZNYRCHOR-CGLBZJNRSA-N",
    "display_name": "CYCLOSPORINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "OPHTHALMIC",
  "spl_meta": {
    "7224d810-bb96-4682-a942-3355e6e8061a": {
      "match": "brand_token",
      "title": "RESTASIS MULTIDOSE (CYCLOSPORINE) EMULSION [ALLERGAN, INC.]",
      "spl_version": "15",
      "published_date": "2025-09-05"
    }
  },
  "productid": "50090-4476_0a22357f-0136-44d5-ab37-0a7d15287b30",
  "productndc": "50090-4476",
  "dosage_form": "EMULSION",
  "orange_book": {
    "appl_no": "050790",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "0.05%",
        "product_no": "001",
        "approval_date": "Dec 23, 2002"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.05%",
        "product_no": "002",
        "approval_date": "Oct 27, 2016"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CYCLOSPORINE",
  "proprietary_name": "RESTASIS",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA050790",
  "marketing_category": "NDA",
  "nonproprietary_name": "cyclosporine",
  "start_marketing_date": "20030401",
  "active_numerator_strength": ".5"
}

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