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United States · US · US:59651-624_19947991-db65-4143-a57c-dc180d695426

Mycophenolate mofetil

Orange BookUNIISPL

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

Identification

ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5965162401
    100 CAPSULE in 1 BOTTLE (59651-624-01)
  • ndc11
    5965162405
    500 CAPSULE in 1 BOTTLE (59651-624-05)

Annotations

UNII (FDA Substance ID)
9242ECW6R0
MYCOPHENOLATE MOFETIL
RxCUI 68149
Orange Book
A217828
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": "59651-624_19947991-db65-4143-a57c-dc180d695426",
  "productndc": "59651-624",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "217828",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "001",
        "approval_date": "Jan 5, 2024"
      }
    ],
    "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": "ANDA217828",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Mycophenolate mofetil",
  "start_marketing_date": "20240105",
  "active_numerator_strength": "250"
}

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