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United States · US · US:75907-047_d94fae26-e557-7f8f-1755-846c8f091506

Cyclosporine

Orange BookUNIISPLATC S01XA18

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

Identification

ManufacturerDr. Reddy's Laboratories Inc
CountryUS (United States)
ATC codeS01XA18
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7590704730
    30 BLISTER PACK in 1 BOX (75907-047-30) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (75907-047-81)

Annotations

UNII (FDA Substance ID)
83HN0GTJ6D
CYCLOSPORINE
RxCUI 3008
Orange Book
A065044
AB1AB1
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": "75907-047_d94fae26-e557-7f8f-1755-846c8f091506",
  "productndc": "75907-047",
  "dosage_form": "CAPSULE, LIQUID FILLED",
  "orange_book": {
    "appl_no": "065044",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Dec 20, 2000"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "25MG",
        "product_no": "002",
        "approval_date": "Dec 20, 2000"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CYCLOSPORINE",
  "proprietary_name": "Cyclosporine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA065044",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cyclosporine",
  "start_marketing_date": "20240701",
  "active_numerator_strength": "25"
}

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