NDC 0074-7269

Gengraf

Cyclosporine

Gengraf is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Abbvie Inc.. The primary component is Cyclosporine.

Product ID0074-7269_246333e8-da30-bcc3-077e-e73865a61b99
NDC0074-7269
Product TypeHuman Prescription Drug
Proprietary NameGengraf
Generic NameCyclosporine
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2010-05-25
Marketing CategoryANDA / ANDA
Application NumberANDA065025
Labeler NameAbbVie Inc.
Substance NameCYCLOSPORINE
Active Ingredient Strength100 mg/mL
Pharm ClassesCalcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0074-7269-50

1 BOTTLE in 1 CARTON (0074-7269-50) > 50 mL in 1 BOTTLE
Marketing Start Date2010-05-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0074-7269-50 [00074726950]

Gengraf SOLUTION
Marketing CategoryANDA
Application NumberANDA065025
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2010-05-25

Drug Details

Active Ingredients

IngredientStrength
CYCLOSPORINE100 mg/mL

OpenFDA Data

SPL SET ID:29891f95-9079-4880-7abc-194e49767dd5
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 835892
  • 835886
  • Pharmacological Class

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

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

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

    Trademark Results [Gengraf]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    GENGRAF
    GENGRAF
    75387943 2441241 Live/Registered
    ABBVIE INC.
    1997-11-10

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