mycophenolic acid

Orange BookUNIISPLATC L04AA06

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

Identification

ManufacturerPD-Rx Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeL04AA06

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7278924798
120 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72789-247-98)

Annotations

UNII (FDA Substance ID)

WX877SQI1G

MYCOPHENOLATE SODIUM

RxCUI 408142

Orange Book

A214289

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": {
    "c1ce92ef-4102-1487-e053-2995a90ac521": {
      "match": "brand_token",
      "title": "MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [SLATE RUN PHARMACEUTICALS, LLC]",
      "spl_version": "13",
      "published_date": "2026-06-01"
    }
  },
  "productid": "72789-247_2d6ca67b-c928-0b22-e063-6394a90a45f9",
  "productndc": "72789-247",
  "dosage_form": "TABLET, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "214289",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 180MG BASE",
        "product_no": "001",
        "approval_date": "Nov 3, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 360MG BASE",
        "product_no": "002",
        "approval_date": "Nov 3, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MYCOPHENOLATE SODIUM",
  "proprietary_name": "mycophenolic acid",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA214289",
  "marketing_category": "ANDA",
  "nonproprietary_name": "mycophenolic acid",
  "start_marketing_date": "20211108",
  "active_numerator_strength": "180"
}

Related drugs

Other records sharing ATC code L04AA06.

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