Mycophenolic Acid

Orange BookUNIISPLATC L04AA06

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

Identification

ManufacturerNovugen Pharma (USA) LLC.

CountryUS (United States)

ATC codeL04AA06

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
8229301310
120 TABLET, DELAYED RELEASE in 1 BOTTLE (82293-013-10)

Annotations

UNII (FDA Substance ID)

WX877SQI1G

MYCOPHENOLATE SODIUM

RxCUI 408142

Orange Book

A216637

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": {
    "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": "82293-013_1f0154d5-686f-170e-e063-6394a90a67e6",
  "productndc": "82293-013",
  "dosage_form": "TABLET, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "216637",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 180MG BASE",
        "product_no": "001",
        "approval_date": "May 29, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 360MG BASE",
        "product_no": "002",
        "approval_date": "May 29, 2024"
      }
    ],
    "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": "ANDA216637",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Mycophenolic Acid",
  "start_marketing_date": "20240901",
  "active_numerator_strength": "360"
}

Related drugs

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