NDC 43353-926

HYZAAR

Losartan Potassium And Hydrochlorothiazide

HYZAAR is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, Llc. The primary component is Losartan Potassium; Hydrochlorothiazide.

Product ID43353-926_377b3679-29e3-4a57-baf1-9761ea57eefc
NDC43353-926
Product TypeHuman Prescription Drug
Proprietary NameHYZAAR
Generic NameLosartan Potassium And Hydrochlorothiazide
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date1995-04-28
Marketing CategoryNDA / NDA
Application NumberNDA020387
Labeler NameAphena Pharma Solutions - Tennessee, LLC
Substance NameLOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE
Active Ingredient Strength50 mg/1; mg/1
Pharm ClassesAngiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 43353-926-60

90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-926-60)
Marketing Start Date1995-04-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43353-926-60 [43353092660]

HYZAAR TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA020387
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1995-04-28
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
LOSARTAN POTASSIUM50 mg/1

OpenFDA Data

SPL SET ID:b82d5bbc-2ead-4060-a37d-7cffb0d87423
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 979468
  • 979470
  • Pharmacological Class

    • Angiotensin 2 Receptor Antagonists [MoA]
    • Angiotensin 2 Receptor Blocker [EPC]
    • Increased Diuresis [PE]
    • Thiazide Diuretic [EPC]
    • Thiazides [CS]

    NDC Crossover Matching brand name "HYZAAR" or generic name "Losartan Potassium And Hydrochlorothiazide"

    NDCBrand NameGeneric Name
    0006-0717HYZAARlosartan potassium and hydrochlorothiazide
    0006-0745HYZAARlosartan potassium and hydrochlorothiazide
    0006-0747HYZAARlosartan potassium and hydrochlorothiazide
    21695-788HYZAARHYZAAR
    43353-926HYZAARHYZAAR
    55289-522HYZAARHYZAAR
    63629-3183HYZAARHYZAAR
    0054-0126Losartan Potassium and HydrochlorothiazideLosartan Potassium and Hydrochlorothiazide
    0054-0127Losartan Potassium and HydrochlorothiazideLosartan Potassium and Hydrochlorothiazide
    0054-0277Losartan Potassium and HydrochlorothiazideLosartan Potassium and Hydrochlorothiazide
    0093-7367Losartan Potassium and HydrochlorothiazideLosartan Potassium and Hydrochlorothiazide
    0093-7368Losartan Potassium and HydrochlorothiazideLosartan Potassium and Hydrochlorothiazide
    0093-7369Losartan Potassium and HydrochlorothiazideLosartan Potassium and Hydrochlorothiazide
    0781-5816losartan potassium and hydrochlorothiazidelosartan potassium and hydrochlorothiazide
    0781-5817losartan potassium and hydrochlorothiazidelosartan potassium and hydrochlorothiazide
    0781-5818losartan potassium and hydrochlorothiazidelosartan potassium and hydrochlorothiazide
    13668-116Losartan Potassium and HydrochlorothiazideLosartan Potassium and Hydrochlorothiazide

    Trademark Results [HYZAAR]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    HYZAAR
    HYZAAR
    74431110 1917146 Live/Registered
    MERCK SHARP & DOHME CORP.
    1993-09-01

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