NDC 50090-4492

Jardiance

Empagliflozin

Jardiance is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by A-s Medication Solutions. The primary component is Empagliflozin.

Product ID50090-4492_3b194971-092d-4b18-8418-8b3ef53e696f
NDC50090-4492
Product TypeHuman Prescription Drug
Proprietary NameJardiance
Generic NameEmpagliflozin
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2014-08-01
Marketing CategoryNDA / NDA
Application NumberNDA204629
Labeler NameA-S Medication Solutions
Substance NameEMPAGLIFLOZIN
Active Ingredient Strength10 mg/1
Pharm ClassesSodium-Glucose Cotransporter 2 Inhibitor [EPC],Sodium-Glucose Transporter 2 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 50090-4492-0

90 TABLET, FILM COATED in 1 BOTTLE (50090-4492-0)
Marketing Start Date2019-08-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50090-4492-0 [50090449200]

Jardiance TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA204629
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-08-29

Drug Details

Active Ingredients

IngredientStrength
EMPAGLIFLOZIN10 mg/1

OpenFDA Data

SPL SET ID:942a82a4-cbbd-4e44-9965-8d03f767912b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1545658
  • 1545664
  • Pharmacological Class

    • Sodium-Glucose Cotransporter 2 Inhibitor [EPC]
    • Sodium-Glucose Transporter 2 Inhibitors [MoA]
    • Sodium-Glucose Cotransporter 2 Inhibitor [EPC]
    • Sodium-Glucose Transporter 2 Inhibitors [MoA]

    NDC Crossover Matching brand name "Jardiance" or generic name "Empagliflozin"

    NDCBrand NameGeneric Name
    0597-0152JardianceEmpagliflozin
    0597-0153JardianceEmpagliflozin
    50090-4384JardianceEmpagliflozin
    50090-4492JardianceEmpagliflozin
    55154-0411JardianceEmpagliflozin
    55154-0412JardianceEmpagliflozin
    70518-1986JardianceEmpagliflozin
    70518-2447JardianceEmpagliflozin
    71610-177JardianceEmpagliflozin

    Trademark Results [Jardiance]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    JARDIANCE
    JARDIANCE
    88902811 not registered Live/Pending
    Boehringer Ingelheim International GmbH
    2020-05-06
    JARDIANCE
    JARDIANCE
    79060588 3595152 Live/Registered
    Boehringer Ingelheim International GmbH
    2008-09-03

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