MYCOPHENOLIC ACID

Orange BookUNIISPLATC L04AA06

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

Identification

ManufacturerAscend Laboratories, LLC

CountryUS (United States)

ATC codeL04AA06

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
6787742705
500 TABLET, DELAYED RELEASE in 1 BOTTLE (67877-427-05)
ndc11
6787742712
120 TABLET, DELAYED RELEASE in 1 BOTTLE (67877-427-12)
ndc11
6787742738
10 BLISTER PACK in 1 CARTON (67877-427-38) / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK (67877-427-33)

Annotations

UNII (FDA Substance ID)

WX877SQI1G

MYCOPHENOLATE SODIUM

RxCUI 408142

Orange Book

A208315

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": "67877-427_27fbf61b-de1e-479a-9d04-6dc1d48f3148",
  "productndc": "67877-427",
  "dosage_form": "TABLET, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "208315",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 180MG BASE",
        "product_no": "001",
        "approval_date": "Sep 23, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 360MG BASE",
        "product_no": "002",
        "approval_date": "Sep 23, 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": "ANDA208315",
  "marketing_category": "ANDA",
  "nonproprietary_name": "MYCOPHENOLIC ACID",
  "start_marketing_date": "20210924",
  "active_numerator_strength": "360"
}

Related drugs

Other records sharing ATC code L04AA06.

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