Mycophenolic Acid

Orange BookUNIISPLATC L04AA06

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

Identification

ManufacturerArchis Pharma LLC

CountryUS (United States)

ATC codeL04AA06

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7281915608
120 TABLET, DELAYED RELEASE in 1 BOTTLE (72819-156-08)

Annotations

UNII (FDA Substance ID)

HU9DX48N0T

MYCOPHENOLIC ACID

RxCUI 7145

Orange Book

A091248

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "HU9DX48N0T",
    "rxcui": "7145",
    "inchikey": "HPNSFSBZBAHARI-RUDMXATFSA-N",
    "display_name": "MYCOPHENOLIC ACID",
    "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": "72819-156_471a0acf-310d-7b67-e063-6294a90adb0e",
  "productndc": "72819-156",
  "dosage_form": "TABLET, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "091248",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 360MG BASE",
        "product_no": "001",
        "approval_date": "Jan 8, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 180MG BASE",
        "product_no": "002",
        "approval_date": "Jan 8, 2014"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MYCOPHENOLIC ACID",
  "proprietary_name": "Mycophenolic Acid",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA091248",
  "marketing_category": "ANDA",
  "nonproprietary_name": "mycophenilic acid",
  "start_marketing_date": "20220221",
  "active_numerator_strength": "360"
}

Related drugs

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