NDC 0597-0300

Synjardy XR

Empagliflozin, Metformin Hydrochloride

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

Product ID0597-0300_2556e57c-d394-4693-b2e9-2b23921abd6b
NDC0597-0300
Product TypeHuman Prescription Drug
Proprietary NameSynjardy XR
Generic NameEmpagliflozin, Metformin Hydrochloride
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2016-12-10
Marketing CategoryNDA / NDA
Application NumberNDA208658
Labeler NameBoehringer Ingelheim Pharmaceuticals, Inc.
Substance NameEMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Active Ingredient Strength13 mg/1; mg/1
Pharm ClassesBiguanide [EPC], Biguanides [CS], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0597-0300-20

1 BOTTLE in 1 CARTON (0597-0300-20) > 14 TABLET, EXTENDED RELEASE in 1 BOTTLE
Marketing Start Date2016-12-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0597-0300-20 [00597030020]

Synjardy XR TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA208658
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-12-10

NDC 0597-0300-45 [00597030045]

Synjardy XR TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA208658
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-12-10

NDC 0597-0300-93 [00597030093]

Synjardy XR TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA208658
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-12-10

Drug Details

Active Ingredients

IngredientStrength
EMPAGLIFLOZIN12.5 mg/1

OpenFDA Data

SPL SET ID:8006ba29-ee3a-f852-a9bb-c8ec9b41cf66
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1862701
  • 1862700
  • 1862697
  • 1862685
  • 1862695
  • 1862692
  • 1862691
  • 1862688
  • UPC Code
  • 0305970300939
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    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

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