NDC 0078-0385

Myfortic

Mycophenolic Acid

Myfortic is a Oral Tablet, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Mycophenolate Sodium.

Product ID0078-0385_0f56c9e8-6fe0-48f2-8676-b96344d201fa
NDC0078-0385
Product TypeHuman Prescription Drug
Proprietary NameMyfortic
Generic NameMycophenolic Acid
Dosage FormTablet, Delayed Release
Route of AdministrationORAL
Marketing Start Date2004-02-27
Marketing CategoryNDA / NDA
Application NumberNDA050791
Labeler NameNovartis Pharmaceuticals Corporation
Substance NameMYCOPHENOLATE SODIUM
Active Ingredient Strength180 mg/1
Pharm ClassesAntimetabolite Immunosuppressant [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0078-0385-66

120 TABLET, DELAYED RELEASE in 1 BOTTLE (0078-0385-66)
Marketing Start Date2004-02-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0078-0385-66 [00078038566]

Myfortic TABLET, DELAYED RELEASE
Marketing CategoryNDA
Application NumberNDA050791
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2004-02-27

Drug Details

Active Ingredients

IngredientStrength
MYCOPHENOLATE SODIUM180 mg/1

OpenFDA Data

SPL SET ID:eed26501-890d-4ff6-88e7-6dbea4726e53
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 616450
  • 616449
  • 485023
  • 485020
    • UPC Code
  • 0300780386661
  • 0300780385664

    • Pharmacological Class

    • Antimetabolite Immunosuppressant [EPC]

    NDC Crossover Matching brand name "Myfortic" or generic name "Mycophenolic Acid"

    NDCBrand NameGeneric Name
    0078-0385Myforticmycophenolic acid
    0078-0386Myforticmycophenolic acid
    0093-7031Mycophenolic AcidMycophenolic Acid
    0093-7032Mycophenolic AcidMycophenolic Acid
    0378-4201Mycophenolic AcidMycophenolic Acid
    0378-4202Mycophenolic AcidMycophenolic Acid
    0904-6785Mycophenolic AcidMycophenolic Acid
    0904-6786Mycophenolic AcidMycophenolic Acid
    16729-189Mycophenolic AcidMycophenolic Acid
    16729-261Mycophenolic AcidMycophenolic Acid
    24979-160mycophenolic acidmycophenolic acid
    24979-161mycophenolic acidmycophenolic acid
    50268-559Mycophenolic AcidMycophenolic Acid
    50268-560Mycophenolic AcidMycophenolic Acid
    60429-016Mycophenolic AcidMycophenolic Acid

    Trademark Results [Myfortic]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    MYFORTIC
    MYFORTIC
    78010134 2490945 Live/Registered
    Novartis AG
    2000-05-26
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