NDC 0004-0259

CellCept

Mycophenolate Mofetil

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

Product ID0004-0259_069ac782-5550-41a9-9179-bc1e44430526
NDC0004-0259
Product TypeHuman Prescription Drug
Proprietary NameCellCept
Generic NameMycophenolate Mofetil
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date1995-05-03
Marketing CategoryNDA / NDA
Application NumberNDA050722
Labeler NameGenentech, Inc.
Substance NameMYCOPHENOLATE MOFETIL
Active Ingredient Strength250 mg/1
Pharm ClassesAntimetabolite Immunosuppressant [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0004-0259-01

1 BOTTLE, PLASTIC in 1 CARTON (0004-0259-01) > 100 CAPSULE in 1 BOTTLE, PLASTIC
Marketing Start Date1995-05-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0004-0259-05 [00004025905]

CellCept CAPSULE
Marketing CategoryNDA
Application NumberNDA050722
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1995-05-03
Marketing End Date2015-06-30

NDC 0004-0259-43 [00004025943]

CellCept CAPSULE
Marketing CategoryNDA
Application NumberNDA050722
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1995-05-03

NDC 0004-0259-01 [00004025901]

CellCept CAPSULE
Marketing CategoryNDA
Application NumberNDA050722
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1995-05-03

Drug Details

Active Ingredients

IngredientStrength
MYCOPHENOLATE MOFETIL250 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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