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United States · US · US:0023-9163_3b350ae7-28e6-4dbd-824c-d0fe46b81e5a

RESTASIS

Orange BookUNIISPLATC S01XA18

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerAllergan, Inc.
CountryUS (United States)
ATC codeS01XA18
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 0

No packs registered.

Annotations

UNII (FDA Substance ID)
83HN0GTJ6D
CYCLOSPORINE
RxCUI 3008
Orange Book
N050790
AB
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": "0023-9163_3b350ae7-28e6-4dbd-824c-d0fe46b81e5a",
  "productndc": "0023-9163",
  "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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