NDC 0597-0180

Synjardy

Empagliflozin And Metformin Hydrochloride

Synjardy is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Boehringer Ingelheim Pharmaceuticals, Inc.. The primary component is Empagliflozin; Metformin Hydrochloride.

Product ID0597-0180_2f7eaca8-aa25-162f-af59-8682293e8590
NDC0597-0180
Product TypeHuman Prescription Drug
Proprietary NameSynjardy
Generic NameEmpagliflozin And Metformin Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2015-08-26
Marketing CategoryNDA / NDA
Application NumberNDA206111
Labeler NameBoehringer Ingelheim Pharmaceuticals, Inc.
Substance NameEMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Active Ingredient Strength13 mg/1; mg/1
Pharm ClassesSodium-Glucose Cotransporter 2 Inhibitor [EPC],Sodium-Glucose Transporter 2 Inhibitors [MoA],Biguanide [EPC],Biguanides [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0597-0180-18

180 TABLET in 1 BOTTLE (0597-0180-18)
Marketing Start Date2015-09-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0597-0180-60 [00597018060]

Synjardy TABLET
Marketing CategoryNDA
Application NumberNDA206111
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-09-12

NDC 0597-0180-66 [00597018066]

Synjardy TABLET
Marketing CategoryNDA
Application NumberNDA206111
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-09-12

NDC 0597-0180-18 [00597018018]

Synjardy TABLET
Marketing CategoryNDA
Application NumberNDA206111
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-09-12

Drug Details

Active Ingredients

IngredientStrength
EMPAGLIFLOZIN12.5 mg/1

OpenFDA Data

SPL SET ID:0fdd0255-0055-65f3-b2c0-db8fbb87beae
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1664315
  • 1665367
  • 1664328
  • 1664326
  • 1664325
  • 1664323
  • 1664321
  • 1665369
  • UPC Code
  • 0305970175186
  • 0305970159605
  • 0305970168188
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Synjardy" or generic name "Empagliflozin And Metformin Hydrochloride"

    NDCBrand NameGeneric Name
    0597-0159Synjardyempagliflozin and metformin hydrochloride
    0597-0168Synjardyempagliflozin and metformin hydrochloride
    0597-0175Synjardyempagliflozin and metformin hydrochloride
    0597-0180Synjardyempagliflozin and metformin hydrochloride
    0597-0280Synjardyempagliflozin, metformin hydrochloride
    0597-0290Synjardyempagliflozin, metformin hydrochloride
    0597-0295Synjardyempagliflozin, metformin hydrochloride
    0597-0300Synjardyempagliflozin, metformin hydrochloride

    Trademark Results [Synjardy]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    SYNJARDY
    SYNJARDY
    79145490 4590924 Live/Registered
    Boehringer Ingelheim International GmbH
    2014-02-17

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.