NDC 0004-0260

CellCept

Mycophenolate Mofetil

CellCept is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Genentech, Inc.. The primary component is Mycophenolate Mofetil.

Product ID0004-0260_069ac782-5550-41a9-9179-bc1e44430526
NDC0004-0260
Product TypeHuman Prescription Drug
Proprietary NameCellCept
Generic NameMycophenolate Mofetil
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date1997-06-19
Marketing CategoryNDA / NDA
Application NumberNDA050723
Labeler NameGenentech, Inc.
Substance NameMYCOPHENOLATE MOFETIL
Active Ingredient Strength500 mg/1
Pharm ClassesAntimetabolite Immunosuppressant [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0004-0260-01

1 BOTTLE, PLASTIC in 1 CARTON (0004-0260-01) > 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Marketing Start Date1997-06-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0004-0260-01 [00004026001]

CellCept TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA050723
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1997-06-19

NDC 0004-0260-43 [00004026043]

CellCept TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA050723
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1997-06-19

Drug Details

Active Ingredients

IngredientStrength
MYCOPHENOLATE MOFETIL500 mg/1

OpenFDA Data

SPL SET ID:37241e87-4af4-4dc3-a1aa-ea6f20d8dc40
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311881
  • 311880
  • 200060
  • 616447
  • 616444
  • 199058
  • 616435
  • 213394
  • Pharmacological Class

    • Antimetabolite Immunosuppressant [EPC]

    NDC Crossover Matching brand name "CellCept" or generic name "Mycophenolate Mofetil"

    NDCBrand NameGeneric Name
    0004-0259CellCeptMycophenolate Mofetil
    0004-0260CellCeptMycophenolate Mofetil
    0004-0261CellCeptMycophenolate Mofetil
    0004-0298CellCeptMycophenolate Mofetil hydrochloride
    21695-171CellCeptCellCept
    0054-0163Mycophenolate MofetilMycophenolate Mofetil
    0054-0166Mycophenolate MofetilMycophenolate Mofetil

    Trademark Results [CellCept]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    CELLCEPT
    CELLCEPT
    74357234 1889130 Live/Registered
    Hoffmann-La Roche Inc
    1993-02-05

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