Mycophenolate Mofetil

Orange BookUNIISPL

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

Identification

ManufacturerBPI Labs LLC

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5428814104
4 VIAL in 1 CARTON (54288-141-04) / 20 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)

UXH81S8ZVB

MYCOPHENOLATE MOFETIL HYDROCHLORIDE

RxCUI 237112

Orange Book

A214283

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "UXH81S8ZVB",
    "rxcui": "237112",
    "inchikey": "OWLCGJBUTJXNOF-HDNKIUSMSA-N",
    "display_name": "MYCOPHENOLATE MOFETIL HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "21ff53b0-b4ba-4473-91e4-76ef41681064": {
      "match": "brand_token",
      "title": "MYCOPHENOLATE MOFETIL POWDER, FOR SUSPENSION [ASCEND LABORATORIES, LLC]",
      "spl_version": "30",
      "published_date": "2026-05-28"
    }
  },
  "productid": "54288-141_1a8abd3a-6834-4468-a443-ca95e795b17d",
  "productndc": "54288-141",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "214283",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "500MG/VIAL",
        "product_no": "001",
        "approval_date": "Jun 1, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MYCOPHENOLATE MOFETIL HYDROCHLORIDE",
  "proprietary_name": "Mycophenolate Mofetil",
  "active_ingred_unit": "mg/20mL",
  "application_number": "ANDA214283",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Mycophenolate Mofetil hydrochloride",
  "start_marketing_date": "20230308",
  "active_numerator_strength": "500"
}

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