NDC 0597-0164

Glyxambi

Empagliflozin And Linagliptin

Glyxambi is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Boehringer Ingelheim Pharmaceuticals, Inc.. The primary component is Empagliflozin; Linagliptin.

Product ID0597-0164_212797a6-c73f-415e-a983-a9e8a8b120a7
NDC0597-0164
Product TypeHuman Prescription Drug
Proprietary NameGlyxambi
Generic NameEmpagliflozin And Linagliptin
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2015-01-30
Marketing CategoryNDA / NDA
Application NumberNDA206073
Labeler NameBoehringer Ingelheim Pharmaceuticals, Inc.
Substance NameEMPAGLIFLOZIN; LINAGLIPTIN
Active Ingredient Strength25 mg/1; mg/1
Pharm ClassesSodium-Glucose Cotransporter 2 Inhibitor [EPC],Sodium-Glucose Transporter 2 Inhibitors [MoA],Dipeptidyl Peptidase 4 Inhibitors [MoA],Dipeptidyl Peptidase 4 Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0597-0164-07

1 BOTTLE in 1 CARTON (0597-0164-07) > 7 TABLET, FILM COATED in 1 BOTTLE
Marketing Start Date2015-01-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0597-0164-07 [00597016407]

Glyxambi TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA206073
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-01-30

NDC 0597-0164-39 [00597016439]

Glyxambi TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA206073
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-01-30

NDC 0597-0164-30 [00597016430]

Glyxambi TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA206073
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-01-30

NDC 0597-0164-70 [00597016470]

Glyxambi TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA206073
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-01-30
Marketing End Date2017-05-01

NDC 0597-0164-90 [00597016490]

Glyxambi TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA206073
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-01-30

NDC 0597-0164-10 [00597016410]

Glyxambi TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA206073
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-01-30
Marketing End Date2017-01-05

Drug Details

Active Ingredients

IngredientStrength
EMPAGLIFLOZIN25 mg/1

OpenFDA Data

SPL SET ID:ddbab689-f76c-488c-9613-4168d41dd730
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1602118
  • 1602109
  • 1602115
  • 1602120
  • Pharmacological Class

    • Sodium-Glucose Cotransporter 2 Inhibitor [EPC]
    • Sodium-Glucose Transporter 2 Inhibitors [MoA]
    • Dipeptidyl Peptidase 4 Inhibitors [MoA]
    • Dipeptidyl Peptidase 4 Inhibitor [EPC]

    NDC Crossover Matching brand name "Glyxambi" or generic name "Empagliflozin And Linagliptin"

    NDCBrand NameGeneric Name
    0597-0164Glyxambiempagliflozin and linagliptin
    0597-0182Glyxambiempagliflozin and linagliptin
    70518-2046Glyxambiempagliflozin and linagliptin

    Trademark Results [Glyxambi]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    GLYXAMBI
    GLYXAMBI
    79129593 4405329 Live/Registered
    Boehringer Ingelheim International GmbH
    2013-03-20

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