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United States · US · US:23155-839_15185077-eec3-40ca-a492-f500a05a045b

CYCLOSPORINE

Orange BookUNIISPLATC S01XA18

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

Identification

ManufacturerHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
CountryUS (United States)
ATC codeS01XA18
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    2315583930
    5 BLISTER PACK in 1 CARTON (23155-839-30) / 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (23155-839-11)

Annotations

UNII (FDA Substance ID)
83HN0GTJ6D
CYCLOSPORINE
RxCUI 3008
Orange Book
A216046
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": {
    "f7e4a2f0-ea2a-449b-bc6d-a6ea3d47b850": {
      "match": "brand_token",
      "title": "CYCLOSPORINE EMULSION [UPSHER-SMITH LABORATORIES, LLC]",
      "spl_version": "2",
      "published_date": "2026-05-25"
    }
  },
  "productid": "23155-839_15185077-eec3-40ca-a492-f500a05a045b",
  "productndc": "23155-839",
  "dosage_form": "CAPSULE, LIQUID FILLED",
  "orange_book": {
    "appl_no": "216046",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Aug 2, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "Aug 2, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "100MG",
        "product_no": "003",
        "approval_date": "Aug 2, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CYCLOSPORINE",
  "proprietary_name": "CYCLOSPORINE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA216046",
  "marketing_category": "ANDA",
  "nonproprietary_name": "CYCLOSPORINE",
  "start_marketing_date": "20221130",
  "active_numerator_strength": "100"
}

Related drugs

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