NDC 0781-5175

Mycophenolate Mofetil

Mycophenolate Mofetil

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

Product ID0781-5175_212ed18a-ebee-4f2b-be5e-dac18b803072
NDC0781-5175
Product TypeHuman Prescription Drug
Proprietary NameMycophenolate Mofetil
Generic NameMycophenolate Mofetil
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2008-10-15
Marketing CategoryANDA / ANDA
Application NumberANDA065451
Labeler NameSandoz Inc
Substance NameMYCOPHENOLATE MOFETIL
Active Ingredient Strength500 mg/1
Pharm ClassesAntimetabolite Immunosuppressant [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0781-5175-01

100 TABLET, FILM COATED in 1 BOTTLE (0781-5175-01)
Marketing Start Date2008-10-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0781-5175-01 [00781517501]

Mycophenolate Mofetil TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA065451
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-10-15

NDC 0781-5175-10 [00781517510]

Mycophenolate Mofetil TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA065451
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-10-15

NDC 0781-5175-05 [00781517505]

Mycophenolate Mofetil TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA065451
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-10-15

Drug Details

Active Ingredients

IngredientStrength
MYCOPHENOLATE MOFETIL500 mg/1

OpenFDA Data

SPL SET ID:99b2eb58-8d14-48fc-bbe1-aacb711a783e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 199058
  • 200060
  • UPC Code
  • 0307815175016
  • 0307812067017
  • 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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.