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United States · US · US:0527-5160_6cb7ed46-e457-4e92-8a15-e771e3dca2d5

Mycophenolate Mofetil

Orange BookUNIISPL

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

Identification

ManufacturerLannett Company, Inc.
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0527516082
    1 BOTTLE, PLASTIC in 1 CARTON (0527-5160-82) / 225 mL in 1 BOTTLE, PLASTIC

Annotations

UNII (FDA Substance ID)
9242ECW6R0
MYCOPHENOLATE MOFETIL
RxCUI 68149
Orange Book
A214525
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": "0527-5160_6cb7ed46-e457-4e92-8a15-e771e3dca2d5",
  "productndc": "0527-5160",
  "dosage_form": "POWDER, FOR SUSPENSION",
  "orange_book": {
    "appl_no": "214525",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG/ML",
        "product_no": "001",
        "approval_date": "Jul 29, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MYCOPHENOLATE MOFETIL",
  "proprietary_name": "Mycophenolate Mofetil",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA214525",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Mycophenolate Mofetil",
  "start_marketing_date": "20210729",
  "active_numerator_strength": "200"
}

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