Myfortic

Orange BookUNIISPLATC L04AA06

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

Identification

ManufacturerNovartis Pharmaceuticals Corporation

CountryUS (United States)

ATC codeL04AA06

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0078038566
120 TABLET, DELAYED RELEASE in 1 BOTTLE (0078-0385-66)

Annotations

UNII (FDA Substance ID)

WX877SQI1G

MYCOPHENOLATE SODIUM

RxCUI 408142

Orange Book

N050791

ABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "WX877SQI1G",
    "rxcui": "408142",
    "inchikey": "DOZYTHNHLLSNIK-JOKMOOFLSA-M",
    "display_name": "MYCOPHENOLATE SODIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "eed26501-890d-4ff6-88e7-6dbea4726e53": {
      "match": "brand_token",
      "title": "MYFORTIC (MYCOPHENOLIC ACID) TABLET, DELAYED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]",
      "spl_version": "35",
      "published_date": "2025-12-10"
    }
  },
  "productid": "0078-0385_c5665f04-bf64-4cc7-b98b-171a8f57155b",
  "productndc": "0078-0385",
  "dosage_form": "TABLET, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "050791",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 180MG BASE",
        "product_no": "001",
        "approval_date": "Feb 27, 2004"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 360MG BASE",
        "product_no": "002",
        "approval_date": "Feb 27, 2004"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MYCOPHENOLATE SODIUM",
  "proprietary_name": "Myfortic",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA050791",
  "marketing_category": "NDA",
  "nonproprietary_name": "mycophenolic acid",
  "start_marketing_date": "20040227",
  "active_numerator_strength": "180"
}

Related drugs

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