NDC 0378-6155

DIGITEK

Digoxin

DIGITEK is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Digoxin.

Product ID0378-6155_00352228-39a9-4cef-9e91-16c5cd009dad
NDC0378-6155
Product TypeHuman Prescription Drug
Proprietary NameDIGITEK
Generic NameDigoxin
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2014-11-17
Marketing CategoryANDA / ANDA
Application NumberANDA040282
Labeler NameMylan Pharmaceuticals Inc.
Substance NameDIGOXIN
Active Ingredient Strength0 mg/1
Pharm ClassesCardiac Glycoside [EPC],Cardiac Glycosides [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0378-6155-01

100 TABLET in 1 BOTTLE, PLASTIC (0378-6155-01)
Marketing Start Date2014-11-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-6155-10 [00378615510]

DIGITEK TABLET
Marketing CategoryANDA
Application NumberANDA040282
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-11-17

NDC 0378-6155-77 [00378615577]

DIGITEK TABLET
Marketing CategoryANDA
Application NumberANDA040282
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-11-17
Marketing End Date2015-11-17

NDC 0378-6155-01 [00378615501]

DIGITEK TABLET
Marketing CategoryANDA
Application NumberANDA040282
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-11-17

NDC 0378-6155-50 [00378615550]

DIGITEK TABLET
Marketing CategoryANDA
Application NumberANDA040282
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-11-17
Marketing End Date2015-11-17

Drug Details

Active Ingredients

IngredientStrength
DIGOXIN.125 mg/1

OpenFDA Data

SPL SET ID:62580c69-3dfc-4286-b298-c387794f8d1d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 260350
  • 260351
  • 197606
  • 197604
    • UPC Code
  • 0303786155019

    • Pharmacological Class

    • Cardiac Glycoside [EPC]
    • Cardiac Glycosides [CS]
    • Cardiac Glycoside [EPC]
    • Cardiac Glycosides [CS]

    NDC Crossover Matching brand name "DIGITEK" or generic name "Digoxin"

    NDCBrand NameGeneric Name
    0378-6155DIGITEKdigoxin
    0378-6156DIGITEKdigoxin
    42292-002DIGITEKDIGITEK
    42292-003DIGITEKDIGITEK
    0527-1324DIGOXDigoxin
    0527-1325DIGOXDigoxin
    0054-0057DigoxinDigoxin
    0115-9811DigoxinDIGOXIN
    0115-9822DigoxinDIGOXIN
    0143-1240DigoxinDigoxin
    0143-1241DigoxinDigoxin
    0404-9850DigoxinDigoxin
    0615-0518DigoxinDigoxin
    0615-0547DigoxinDigoxin
    0615-7729DigoxinDigoxin
    0615-7730DigoxinDigoxin
    0615-7935DIGOXINDIGOXIN
    0615-8202DigoxinDigoxin
    0641-1410DigoxinDigoxin
    0641-6184DigoxinDigoxin
    0781-3059DigoxinDigoxin
    0904-5921DigoxinDigoxin

    Trademark Results [DIGITEK]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    DIGITEK
    DIGITEK
    98598355 not registered Live/Pending
    IMS MERCANTILES PRIVATE LIMITED
    2024-06-12
    DIGITEK
    DIGITEK
    87871491 not registered Live/Pending
    United Brands Products Design, Development and Marketing, Inc.
    2018-04-10
    DIGITEK
    DIGITEK
    87871440 not registered Dead/Abandoned
    United Brands Products Design, Development and Marketing, Inc.
    2018-04-10
    DIGITEK
    DIGITEK
    86957205 5054728 Live/Registered
    Franklin Sports, Inc.
    2016-03-29
    DIGITEK
    DIGITEK
    77609297 3635016 Live/Registered
    CAROLINA WHOLESALE GROUP, INC.
    2008-11-06
    DIGITEK
    DIGITEK
    77150841 3421640 Dead/Cancelled
    DIGITEK TECHNOLOGY CO., LTD.
    2007-04-06
    DIGITEK
    DIGITEK
    76577493 not registered Dead/Abandoned
    Tkacz, Eduardo
    2004-02-25
    DIGITEK
    DIGITEK
    76343449 2624778 Dead/Cancelled
    DIGITEK TECHNOLOGY CO., LTD
    2001-11-30
    DIGITEK
    DIGITEK
    76142774 2587609 Dead/Cancelled
    UNITED SUPPLY, INC.
    2000-10-10
    DIGITEK
    DIGITEK
    75479076 2365108 Live/Registered
    MYLAN BERTEK PHARMACEUTICALS, INC.
    1998-05-04
    DIGITEK
    DIGITEK
    75194071 2223548 Dead/Cancelled
    WARNER, BARTON
    1996-11-06
    DIGITEK
    DIGITEK
    74370365 1806088 Dead/Cancelled
    Marvel Comics Ltd.
    1993-03-19
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.