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United States · US · US:60505-6202_58c5fb86-01c3-497b-86f7-a65055732970

Cyclosporine

Orange BookUNIISPLATC S01XA18

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

Identification

ManufacturerApotex Corp
CountryUS (United States)
ATC codeS01XA18
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6050562021
    30 VIAL in 1 TRAY (60505-6202-1) / .4 mL in 1 VIAL
  • ndc11
    6050562022
    60 VIAL in 1 TRAY (60505-6202-2) / .4 mL in 1 VIAL

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": {
    "f7e4a2f0-ea2a-449b-bc6d-a6ea3d47b850": {
      "match": "brand_token",
      "title": "CYCLOSPORINE EMULSION [UPSHER-SMITH LABORATORIES, LLC]",
      "spl_version": "2",
      "published_date": "2026-05-25"
    }
  },
  "productid": "60505-6202_58c5fb86-01c3-497b-86f7-a65055732970",
  "productndc": "60505-6202",
  "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": "Cyclosporine",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA050790",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Cyclosporine",
  "start_marketing_date": "20220207",
  "active_numerator_strength": ".5"
}

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