CycloSPORINE, Modfied

Orange BookUNIISPLATC S01XA18

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

Identification

ManufacturerApotex Corp.

CountryUS (United States)

ATC codeS01XA18

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6050546323
30 BLISTER PACK in 1 CARTON (60505-4632-3) / 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

83HN0GTJ6D

CYCLOSPORINE

RxCUI 3008

Orange Book

A210721

AB1AB1AB1

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": {
    "5baaf78c-90f6-abcf-52c8-814490f3cf9f": {
      "match": "brand_token",
      "title": "CYCLOSPORINE, MODFIED (CYCLOSPORINE) CAPSULE, LIQUID FILLED [APOTEX CORP.]",
      "spl_version": "9",
      "published_date": "2025-09-19"
    }
  },
  "productid": "60505-4632_5cee848b-4ce1-07e1-419d-8664662517d5",
  "productndc": "60505-4632",
  "dosage_form": "CAPSULE, LIQUID FILLED",
  "orange_book": {
    "appl_no": "210721",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Jul 10, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "Jul 10, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "100MG",
        "product_no": "003",
        "approval_date": "Jul 10, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CYCLOSPORINE",
  "proprietary_name": "CycloSPORINE, Modfied",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA210721",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cyclosporine",
  "start_marketing_date": "20191105",
  "active_numerator_strength": "100"
}

Related drugs

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