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United States · US · US:68254-5003_6eb2ddd0-ab23-44ae-a1ce-acc44e4f7e29

MYCOPHENOLATE MOFETIL

Orange BookUNIISPL

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerCONCORD BIOTECH LIMITED
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    6825450031
    30 TABLET in 1 BOTTLE (68254-5003-1)
  • ndc11
    6825450032
    100 TABLET in 1 BOTTLE (68254-5003-2)
  • ndc11
    6825450033
    500 TABLET in 1 BOTTLE (68254-5003-3)

Annotations

UNII (FDA Substance ID)
9242ECW6R0
MYCOPHENOLATE MOFETIL
RxCUI 68149
Orange Book
A212087
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "9242ECW6R0",
    "rxcui": "68149",
    "inchikey": "RTGDFNSFWBGLEC-SYZQJQIISA-N",
    "display_name": "MYCOPHENOLATE MOFETIL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "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": "68254-5003_6eb2ddd0-ab23-44ae-a1ce-acc44e4f7e29",
  "productndc": "68254-5003",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "212087",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "001",
        "approval_date": "Jul 31, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MYCOPHENOLATE MOFETIL",
  "proprietary_name": "MYCOPHENOLATE MOFETIL",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA212087",
  "marketing_category": "ANDA",
  "nonproprietary_name": "MYCOPHENOLATE MOFETIL",
  "start_marketing_date": "20201221",
  "active_numerator_strength": "500"
}

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