NDC 0054-0166

Mycophenolate Mofetil

Mycophenolate Mofetil

Mycophenolate Mofetil is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Hikma Pharmaceuticals Usa Inc.. The primary component is Mycophenolate Mofetil.

Product ID0054-0166_0873dff6-5ffd-44c8-8b71-a0627e8f71be
NDC0054-0166
Product TypeHuman Prescription Drug
Proprietary NameMycophenolate Mofetil
Generic NameMycophenolate Mofetil
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2008-07-29
Marketing CategoryANDA / ANDA
Application NumberANDA065413
Labeler NameHikma Pharmaceuticals USA Inc.
Substance NameMYCOPHENOLATE MOFETIL
Active Ingredient Strength500 mg/1
Pharm ClassesAntimetabolite Immunosuppressant [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0054-0166-25

100 TABLET in 1 BOTTLE (0054-0166-25)
Marketing Start Date2008-07-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0054-0166-29 [00054016629]

Mycophenolate Mofetil TABLET
Marketing CategoryANDA
Application NumberANDA065413
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-07-29

NDC 0054-0166-25 [00054016625]

Mycophenolate Mofetil TABLET
Marketing CategoryANDA
Application NumberANDA065413
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-07-29

Drug Details

Active Ingredients

IngredientStrength
MYCOPHENOLATE MOFETIL500 mg/1

OpenFDA Data

SPL SET ID:e94895d9-f040-4a75-9f04-9814238b8f3c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 199058
  • 200060
  • UPC Code
  • 0300540163259
  • 0300540166250
  • Pharmacological Class

    • Antimetabolite Immunosuppressant [EPC]

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

    NDCBrand NameGeneric Name
    0054-0163Mycophenolate MofetilMycophenolate Mofetil
    0054-0166Mycophenolate MofetilMycophenolate Mofetil
    0093-7334Mycophenolate MofetilMycophenolate Mofetil
    67877-225Mycophenolate MofetilMycophenolate Mofetil
    67877-230Mycophenolate mofetilMycophenolate mofetil
    67877-266mycophenolate mofetilmycophenolate mofetil
    68084-795Mycophenolate MofetilMycophenolate Mofetil
    68084-801Mycophenolate mofetilMycophenolate mofetil
    68254-5000MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL
    68382-130Mycophenolate MofetilMycophenolate Mofetil
    68382-131Mycophenolate MofetilMycophenolate Mofetil
    68382-669Mycophenolate MofetilMycophenolate Mofetil
    69189-0164Mycophenolate MofetilMycophenolate Mofetil
    70771-1084Mycophenolate MofetilMycophenolate Mofetil
    71610-033Mycophenolate MofetilMycophenolate Mofetil
    0781-2067Mycophenolate MofetilMycophenolate Mofetil
    0781-5175Mycophenolate MofetilMycophenolate Mofetil
    16729-094mycophenolate mofetilmycophenolate mofetil
    17478-422Mycophenolate MofetilMycophenolate Mofetil
    17478-957Mycophenolate MofetilMycophenolate Mofetil
    16729-019mycophenolate mofetilmycophenolate mofetil
    0093-7477mycophenolate mofetilmycophenolate mofetil
    42023-172Mycophenolate MofetilMycophenolate Mofetil
    42658-101Mycophenolate MofetilMycophenolate Mofetil
    42658-501Mycophenolate MofetilMycophenolate Mofetil
    50090-2246Mycophenolate mofetilMycophenolate mofetil
    50090-2541mycophenolate mofetilmycophenolate mofetil
    51079-721Mycophenolate MofetilMycophenolate Mofetil
    51079-379Mycophenolate MofetilMycophenolate Mofetil
    55154-5382Mycophenolate MofetilMycophenolate Mofetil
    55154-6262Mycophenolate MofetilMycophenolate Mofetil
    60429-059Mycophenolate MofetilMycophenolate Mofetil
    60429-070Mycophenolate MofetilMycophenolate Mofetil
    0378-2250Mycophenolate MofetilMycophenolate Mofetil
    0378-4472Mycophenolate MofetilMycophenolate Mofetil
    64380-726Mycophenolate mofetilMycophenolate mofetil
    64380-725Mycophenolate mofetilMycophenolate mofetil
    65841-681Mycophenolate MofetilMycophenolate Mofetil
    65841-680Mycophenolate MofetilMycophenolate Mofetil
    66689-307Mycophenolate MofetilMycophenolate Mofetil
    50090-4275Mycophenolate MofetilMycophenolate Mofetil
    70748-186MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL
    0004-0259CellCeptMycophenolate Mofetil
    0004-0260CellCeptMycophenolate Mofetil
    0004-0261CellCeptMycophenolate Mofetil

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