Neoral

Orange BookUNIISPLATC S01XA18

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

Identification

ManufacturerNovartis Pharmaceuticals Corporation

CountryUS (United States)

ATC codeS01XA18

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0078024815
30 BLISTER PACK in 1 CARTON (0078-0248-15) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0078-0248-61)

Annotations

UNII (FDA Substance ID)

83HN0GTJ6D

CYCLOSPORINE

RxCUI 3008

Orange Book

N050715

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": {
    "94461af3-11f1-4670-95d4-2965b9538ae3": {
      "match": "brand_token",
      "title": "NEORAL (CYCLOSPORINE) CAPSULE, LIQUID FILLED NEORAL (CYCLOSPORINE) SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION]",
      "spl_version": "28",
      "published_date": "2025-12-23"
    }
  },
  "productid": "0078-0248_df11902a-3b90-428d-80f5-d587be982b4c",
  "productndc": "0078-0248",
  "dosage_form": "CAPSULE, LIQUID FILLED",
  "orange_book": {
    "appl_no": "050715",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB1",
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Jul 14, 1995"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB1",
        "strength": "100MG",
        "product_no": "002",
        "approval_date": "Jul 14, 1995"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "003",
        "approval_date": "Jul 14, 1995"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CYCLOSPORINE",
  "proprietary_name": "Neoral",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA050715",
  "marketing_category": "NDA",
  "nonproprietary_name": "cyclosporine",
  "start_marketing_date": "19950714",
  "active_numerator_strength": "100"
}

Related drugs

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