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United States · US · US:0004-0298_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
    0004029809
    4 VIAL in 1 CARTON (0004-0298-09) / 20 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
UXH81S8ZVB
MYCOPHENOLATE MOFETIL HYDROCHLORIDE
RxCUI 237112
Orange Book
N050758
AP
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": {
    "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": "0004-0298_ad799779-cc87-4d12-9836-74375149b84b",
  "productndc": "0004-0298",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "050758",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "500MG/VIAL",
        "product_no": "001",
        "approval_date": "Aug 12, 1998"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MYCOPHENOLATE MOFETIL HYDROCHLORIDE",
  "proprietary_name": "CellCept",
  "active_ingred_unit": "mg/20mL",
  "application_number": "NDA050758",
  "marketing_category": "NDA",
  "nonproprietary_name": "Mycophenolate Mofetil hydrochloride",
  "start_marketing_date": "19980812",
  "active_numerator_strength": "500"
}

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