NDC 0078-0246

Neoral

Cyclosporine

Neoral 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 ID0078-0246_06576850-10a7-4bc8-a8e4-2605b40448e4
NDC0078-0246
Product TypeHuman Prescription Drug
Proprietary NameNeoral
Generic NameCyclosporine
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date1995-07-14
Marketing CategoryNDA / NDA
Application NumberNDA050715
Labeler NameNovartis Pharmaceuticals Corporation
Substance NameCYCLOSPORINE
Active Ingredient Strength25 mg/1
Pharm ClassesCalcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0078-0246-15

30 BLISTER PACK in 1 CARTON (0078-0246-15) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0078-0246-61)
Marketing Start Date1995-07-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0078-0246-61 [00078024661]

Neoral CAPSULE, LIQUID FILLED
Marketing CategoryNDA
Application NumberNDA050715
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-08-13

NDC 0078-0246-15 [00078024615]

Neoral CAPSULE, LIQUID FILLED
Marketing CategoryNDA
Application NumberNDA050715
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1995-07-14

Drug Details

Active Ingredients

IngredientStrength
CYCLOSPORINE25 mg/1

OpenFDA Data

SPL SET ID:94461af3-11f1-4670-95d4-2965b9538ae3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 835911
  • 835899
  • 835909
  • 835886
  • 835894
  • 241834
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0078-0246Neoralcyclosporine
    0078-0248Neoralcyclosporine
    0078-0274NeoralNeoral
    0074-3108GengrafCyclosporine
    0074-3109GengrafCyclosporine
    0074-7269GengrafCyclosporine
    0023-9163RESTASIScyclosporine
    0023-5301Restasis MultiDosecyclosporine
    0078-0109Sandimmunecyclosporine
    0078-0110Sandimmunecyclosporine
    0078-0240Sandimmunecyclosporine
    0078-0241Sandimmunecyclosporine

    Trademark Results [Neoral]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    NEORAL
    NEORAL
    78261043 not registered Dead/Abandoned
    Novartis AG
    2003-06-11
    NEORAL
    NEORAL
    75599018 not registered Dead/Abandoned
    Novartis AG
    1998-12-11
    NEORAL
    NEORAL
    74634767 not registered Dead/Abandoned
    SANDOZ AG (SANDOZ LTD., SANDOZ S.A.)
    1995-02-16
    NEORAL
    NEORAL
    74448032 1895538 Live/Registered
    NOVARTIS AG
    1993-10-14

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