NDC 64725-1324

DIGOX

Digoxin

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

Product ID64725-1324_137ab467-1a5e-4159-a27d-54700ff0369e
NDC64725-1324
Product TypeHuman Prescription Drug
Proprietary NameDIGOX
Generic NameDigoxin
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2002-07-26
Marketing CategoryANDA / ANDA
Application NumberANDA076268
Labeler NameTYA Pharmaceuticals
Substance NameDIGOXIN
Active Ingredient Strength125 ug/1
Pharm ClassesCardiac Glycoside [EPC],Cardiac Glycosides [CS]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 64725-1324-1

100 TABLET in 1 BOTTLE (64725-1324-1)
Marketing Start Date2002-07-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 64725-1324-1 [64725132401]

DIGOX TABLET
Marketing CategoryANDA
Application NumberANDA076268
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2002-07-26
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
DIGOXIN125 ug/1

OpenFDA Data

SPL SET ID:5978ebed-8485-48e7-9157-2082384cb1fc
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1245443
  • 197604

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0527-1324DIGOXDigoxin
    0527-1325DIGOXDigoxin
    68151-1603DIGOXDIGOX
    68151-1602DIGOXDIGOX
    49999-181DIGOXDIGOX
    50090-0962DigoxDigox
    53217-005DIGOXDIGOX
    63187-740DIGOXDIGOX
    64725-1324DIGOXDIGOX
    0378-6155DIGITEKdigoxin
    0378-6156DIGITEKdigoxin
    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 [DIGOX]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    DIGOX
    DIGOX
    77799307 3958609 Dead/Cancelled
    Lannett Holdings, Inc.
    2009-08-07
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.