NDC 27505-111

Xadago

Safinamide Mesylate

Xadago is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Us Worldmeds, Llc. The primary component is Safinamide Mesylate.

Product ID27505-111_0e434cb6-5220-44c2-a9cc-0b085946a007
NDC27505-111
Product TypeHuman Prescription Drug
Proprietary NameXadago
Generic NameSafinamide Mesylate
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2017-05-08
Marketing CategoryNDA / NDA
Application NumberNDA207145
Labeler NameUS WorldMeds, LLC
Substance NameSAFINAMIDE MESYLATE
Active Ingredient Strength100 mg/1
Pharm ClassesMonoamine Oxidase Type B Inhibitor [EPC],Monoamine Oxidase-B Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 27505-111-14

1 BLISTER PACK in 1 CARTON (27505-111-14) > 14 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date2017-05-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 27505-111-30 [27505011130]

Xadago TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA207145
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-05-08

NDC 27505-111-14 [27505011114]

Xadago TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA207145
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-05-08

NDC 27505-111-90 [27505011190]

Xadago TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA207145
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-05-08

Drug Details

Active Ingredients

IngredientStrength
SAFINAMIDE MESYLATE100 mg/1

OpenFDA Data

SPL SET ID:c4d65f28-983f-42b4-bb23-023ae0fe81b2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1922472
  • 1922474
  • 1922466
  • 1922476
  • Pharmacological Class

    • Monoamine Oxidase Type B Inhibitor [EPC]
    • Monoamine Oxidase-B Inhibitors [MoA]
    • Breast Cancer Resistance Protein Inhibitors [MoA]

    NDC Crossover Matching brand name "Xadago" or generic name "Safinamide Mesylate"

    NDCBrand NameGeneric Name
    27505-110Xadagosafinamide mesylate
    27505-111Xadagosafinamide mesylate

    Trademark Results [Xadago]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    XADAGO
    XADAGO
    85842346 4630663 Live/Registered
    ZAMBON S.P.A.
    2013-02-06

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