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United States · US · US:60505-0133_561ed7a8-f342-f4fe-ce36-998d87c33e7f

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 · 1

  • ndc11
    6050501330
    30 CAPSULE, GELATIN COATED in 1 BOTTLE (60505-0133-0)

Annotations

UNII (FDA Substance ID)
83HN0GTJ6D
CYCLOSPORINE
RxCUI 3008
Orange Book
A065040
AB2AB2
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": "ORAL",
  "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": "60505-0133_561ed7a8-f342-f4fe-ce36-998d87c33e7f",
  "productndc": "60505-0133",
  "dosage_form": "CAPSULE, GELATIN COATED",
  "orange_book": {
    "appl_no": "065040",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB2",
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "May 9, 2002"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB2",
        "strength": "100MG",
        "product_no": "002",
        "approval_date": "May 9, 2002"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CYCLOSPORINE",
  "proprietary_name": "Cyclosporine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA065040",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cyclosporine",
  "start_marketing_date": "20020529",
  "active_numerator_strength": "25"
}

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