NDC 65197-003

Dyrenium

Triamterene

Dyrenium is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Wellspring Pharmaceutical Corporation. The primary component is Triamterene.

Product ID65197-003_96d12576-d968-41bc-ad64-fd3812e09f25
NDC65197-003
Product TypeHuman Prescription Drug
Proprietary NameDyrenium
Generic NameTriamterene
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date1999-01-01
Marketing End Date2020-01-31
Marketing CategoryNDA / NDA
Application NumberNDA013174
Labeler NameWellSpring Pharmaceutical Corporation
Substance NameTRIAMTERENE
Active Ingredient Strength100 mg/1
Pharm ClassesDecreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC]
NDC Exclude FlagN

Packaging

NDC 65197-003-01

100 CAPSULE in 1 BOTTLE (65197-003-01)
Marketing Start Date1999-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65197-003-01 [65197000301]

Dyrenium CAPSULE
Marketing CategoryNDA
Application NumberNDA013174
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1999-01-01
Marketing End Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
TRIAMTERENE100 mg/1

OpenFDA Data

SPL SET ID:5012f997-9fb2-4c3d-99fd-4f7efd7c39af
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198312
  • 198313
  • 208675
  • 208674
  • UPC Code
  • 0365197002061
  • 0365197002016
  • 0365197003013
  • Pharmacological Class

    • Decreased Renal K+ Excretion [PE]
    • Increased Diuresis [PE]
    • Potassium-sparing Diuretic [EPC]

    NDC Crossover Matching brand name "Dyrenium" or generic name "Triamterene"

    NDCBrand NameGeneric Name
    59212-002DyreniumTriamterene
    59212-003DyreniumTriamterene
    65197-002DyreniumTriamterene
    65197-003DyreniumTriamterene
    68151-1494DyreniumTriamterene
    66993-831triamtereneTriamterene
    66993-832TriamtereneTriamterene

    Trademark Results [Dyrenium]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    DYRENIUM
    DYRENIUM
    72193818 0785081 Live/Registered
    SMITH KLINE & FRENCH LABORATORIES
    1964-05-19

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