NDC 0024-5855

Avalide

Irbesartan And Hydrochlorothiazide

Avalide is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Sanofi-aventis U.s. Llc. The primary component is Irbesartan; Hydrochlorothiazide.

Product ID0024-5855_18162dad-7813-4074-b159-d94ce6bb5fca
NDC0024-5855
Product TypeHuman Prescription Drug
Proprietary NameAvalide
Generic NameIrbesartan And Hydrochlorothiazide
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2013-01-01
Marketing CategoryNDA / NDA
Application NumberNDA020758
Labeler Namesanofi-aventis U.S. LLC
Substance NameIRBESARTAN; HYDROCHLOROTHIAZIDE
Active Ingredient Strength150 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 Through2022-12-31

Packaging

NDC 0024-5855-30

30 TABLET, FILM COATED in 1 BOTTLE (0024-5855-30)
Marketing Start Date2013-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0024-5855-30 [00024585530]

Avalide TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA020758
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-01-01

NDC 0024-5855-90 [00024585590]

Avalide TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA020758
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-01-01
Marketing End Date2016-12-31

Drug Details

Active Ingredients

IngredientStrength
IRBESARTAN150 mg/1

OpenFDA Data

SPL SET ID:0d91895e-c869-4b33-9b83-d55c1ad6317e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310792
  • 310793
  • 823938
  • 823934
  • 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 "Avalide" or generic name "Irbesartan And Hydrochlorothiazide"

    NDCBrand NameGeneric Name
    0024-5855Avalideirbesartan and hydrochlorothiazide
    0024-5856Avalideirbesartan and hydrochlorothiazide
    0054-0254Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
    0054-0255Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
    0093-8232Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
    0093-8238Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
    0955-1045Irbesartan and Hydrochlorothiazideirbesartan and hydrochlorothiazide
    0955-1046Irbesartan and Hydrochlorothiazideirbesartan and hydrochlorothiazide

    Trademark Results [Avalide]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    AVALIDE
    AVALIDE
    78260376 3068965 Dead/Cancelled
    SANOFI
    2003-06-10
    AVALIDE
    AVALIDE
    75375830 2312337 Live/Registered
    SANOFI
    1997-10-20

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