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United States · US · US:68084-921_1857b1ea-c3f7-696a-e063-6394a90ad6eb

Cyclosporine

Orange BookUNIISPLATC S01XA18

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

Identification

ManufacturerAmerican Health Packaging
CountryUS (United States)
ATC codeS01XA18
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6808492125
    30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-921-25) / 1 CAPSULE, GELATIN COATED in 1 BLISTER PACK (68084-921-95)

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": "68084-921_1857b1ea-c3f7-696a-e063-6394a90ad6eb",
  "productndc": "68084-921",
  "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": "20151103",
  "active_numerator_strength": "100"
}

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