NDC 0074-3108

Gengraf

Cyclosporine

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

Product ID0074-3108_4abab0be-cf15-0095-c5ad-fcc3bf039d4f
NDC0074-3108
Product TypeHuman Prescription Drug
Proprietary NameGengraf
Generic NameCyclosporine
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2015-11-01
Marketing CategoryANDA / ANDA
Application NumberANDA065003
Labeler NameAbbVie Inc.
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 Through2021-12-31

Packaging

NDC 0074-3108-32

3 BLISTER PACK in 1 CARTON (0074-3108-32) > 10 CAPSULE in 1 BLISTER PACK
Marketing Start Date2015-11-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0074-3108-32 [00074310832]

Gengraf CAPSULE
Marketing CategoryANDA
Application NumberANDA065003
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-11-01

Drug Details

Active Ingredients

IngredientStrength
CYCLOSPORINE25 mg/1

OpenFDA Data

SPL SET ID:e896cbfe-4745-4088-82a3-8dc10b75c41f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1797521
  • 835925
  • 241834
  • 835894
  • 835835
  • 835896
  • Pharmacological Class

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