NDC 0310-6205

FARXIGA

Dapagliflozin

FARXIGA is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Astrazeneca Pharmaceuticals Lp. The primary component is Dapagliflozin Propanediol.

Product ID0310-6205_05eedd34-9c14-4d91-b36c-b661eff3401e
NDC0310-6205
Product TypeHuman Prescription Drug
Proprietary NameFARXIGA
Generic NameDapagliflozin
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2008-01-14
Marketing CategoryNDA / NDA
Application NumberNDA202293
Labeler NameAstraZeneca Pharmaceuticals LP
Substance NameDAPAGLIFLOZIN PROPANEDIOL
Active Ingredient Strength5 mg/1
Pharm ClassesSodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0310-6205-30

30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-6205-30)
Marketing Start Date2015-02-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0310-6205-95 [00310620595]

FARXIGA TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA202293
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-02-02

NDC 0310-6205-30 [00310620530]

FARXIGA TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA202293
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-02-02

Drug Details

Active Ingredients

IngredientStrength
DAPAGLIFLOZIN PROPANEDIOL5 mg/1

OpenFDA Data

SPL SET ID:72ad22ae-efe6-4cd6-a302-98aaee423d69
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1488569
  • 1486977
  • 1486981
  • 1488574
  • UPC Code
  • 0300000000001
  • Pharmacological Class

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

    NDC Crossover Matching brand name "FARXIGA" or generic name "Dapagliflozin"

    NDCBrand NameGeneric Name
    0310-6205FARXIGADAPAGLIFLOZIN
    0310-6210FARXIGADAPAGLIFLOZIN
    50090-3481FARXIGADAPAGLIFLOZIN
    50090-3482FARXIGADAPAGLIFLOZIN
    55154-6932FARXIGADAPAGLIFLOZIN
    55154-6933FARXIGAFARXIGA

    Trademark Results [FARXIGA]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    FARXIGA
    FARXIGA
    88639033 not registered Live/Pending
    AstraZeneca AB
    2019-10-02
    FARXIGA
    FARXIGA
    86049285 4638205 Live/Registered
    Bristol-Myers Squibb Company
    2013-08-27

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