NDC 0078-0241

Sandimmune

Cyclosporine

Sandimmune is a Oral Capsule, Liquid Filled in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Cyclosporine.

Product ID0078-0241_1e8368df-ba5b-49ad-8efa-a8814b91e186
NDC0078-0241
Product TypeHuman Prescription Drug
Proprietary NameSandimmune
Generic NameCyclosporine
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date1990-03-02
Marketing CategoryNDA / NDA
Application NumberNDA050625
Labeler NameNovartis Pharmaceuticals Corporation
Substance NameCYCLOSPORINE
Active Ingredient Strength100 mg/1
Pharm ClassesCalcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0078-0241-15

30 BLISTER PACK in 1 PACKAGE (0078-0241-15) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0078-0241-61)
Marketing Start Date1990-03-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0078-0241-61 [00078024161]

Sandimmune CAPSULE, LIQUID FILLED
Marketing CategoryNDA
Application NumberNDA050625
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-03-22

NDC 0078-0241-15 [00078024115]

Sandimmune CAPSULE, LIQUID FILLED
Marketing CategoryNDA
Application NumberNDA050625
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1990-03-02

Drug Details

Active Ingredients

IngredientStrength
CYCLOSPORINE100 mg/1

OpenFDA Data

SPL SET ID:5e5926a7-1de0-4b54-a5c0-286b6200ff82
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 205175
  • 197553
  • 197552
  • 212844
  • 212957
  • 212810
  • 309632
  • 328160
  • Pharmacological Class

    • Calcineurin Inhibitor Immunosuppressant [EPC]
    • Calcineurin Inhibitors [MoA]
    • Cytochrome P450 3A4 Inhibitors [MoA]
    • P-Glycoprotein Inhibitors [MoA]

    NDC Crossover Matching brand name "Sandimmune" or generic name "Cyclosporine"

    NDCBrand NameGeneric Name
    0078-0109Sandimmunecyclosporine
    0078-0110Sandimmunecyclosporine
    0078-0240Sandimmunecyclosporine
    0078-0241Sandimmunecyclosporine
    0074-3108GengrafCyclosporine
    0074-3109GengrafCyclosporine
    0074-7269GengrafCyclosporine
    0078-0246Neoralcyclosporine
    0078-0248Neoralcyclosporine
    0023-9163RESTASIScyclosporine
    0023-5301Restasis MultiDosecyclosporine

    Trademark Results [Sandimmune]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    SANDIMMUNE
    SANDIMMUNE
    73394128 1273295 Live/Registered
    Sandoz, Inc.
    1982-09-29

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