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United States · US · US:0004-0261_ad799779-cc87-4d12-9836-74375149b84b

CellCept

Orange BookUNIISPL

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

Identification

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

Packs · 1

  • ndc11
    0004026129
    1 BOTTLE, PLASTIC in 1 CARTON (0004-0261-29) / 225 mL in 1 BOTTLE, PLASTIC

Annotations

UNII (FDA Substance ID)
9242ECW6R0
MYCOPHENOLATE MOFETIL
RxCUI 68149
Orange Book
N050759
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": {
    "37241e87-4af4-4dc3-a1aa-ea6f20d8dc40": {
      "match": "brand_token",
      "title": "CELLCEPT (MYCOPHENOLATE MOFETIL) TABLET, FILM COATED CELLCEPT (MYCOPHENOLATE MOFETIL) CAPSULE CELLCEPT (MYCOPHENOLATE MOFETIL HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION CELLCEPT (MYCOPHENOLATE MOFETIL) POWDER, FOR SUSPENSION [GENENTECH, INC.]",
      "spl_version": "50",
      "published_date": "2025-12-02"
    }
  },
  "productid": "0004-0261_ad799779-cc87-4d12-9836-74375149b84b",
  "productndc": "0004-0261",
  "dosage_form": "POWDER, FOR SUSPENSION",
  "orange_book": {
    "appl_no": "050759",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "200MG/ML",
        "product_no": "001",
        "approval_date": "Oct 1, 1998"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MYCOPHENOLATE MOFETIL",
  "proprietary_name": "CellCept",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA050759",
  "marketing_category": "NDA",
  "nonproprietary_name": "Mycophenolate Mofetil",
  "start_marketing_date": "19981001",
  "active_numerator_strength": "200"
}

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