NDC 68071-2123

Irbesartan and Hydrochlorothiazide

Irbesartan And Hydrochlorothiazide

Irbesartan and Hydrochlorothiazide is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Nucare Pharmaceuticals, Inc.. The primary component is Irbesartan; Hydrochlorothiazide.

Product ID68071-2123_46f10483-af5e-46af-e054-00144ff8d46c
NDC68071-2123
Product TypeHuman Prescription Drug
Proprietary NameIrbesartan and Hydrochlorothiazide
Generic NameIrbesartan And Hydrochlorothiazide
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2012-09-27
Marketing CategoryANDA / ANDA
Application NumberANDA202414
Labeler NameNuCare Pharmaceuticals, Inc.
Substance NameIRBESARTAN; HYDROCHLOROTHIAZIDE
Active Ingredient Strength300 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 Through2020-12-31

Packaging

NDC 68071-2123-3

30 TABLET, FILM COATED in 1 BOTTLE (68071-2123-3)
Marketing Start Date2017-01-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68071-2123-3 [68071212303]

Irbesartan and Hydrochlorothiazide TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA202414
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-01-25
Marketing End Date2018-12-31

Drug Details

Active Ingredients

IngredientStrength
IRBESARTAN300 mg/1

OpenFDA Data

SPL SET ID:46f0a3af-313c-36b2-e054-00144ff8d46c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310793

    • 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 "Irbesartan and Hydrochlorothiazide" or generic name "Irbesartan And Hydrochlorothiazide"

    NDCBrand NameGeneric Name
    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
    68071-2123Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
    68180-413Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
    68180-414Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
    68645-405Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
    70518-1386Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
    70518-1331Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
    70518-1330Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
    70518-1550Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
    70518-1780Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
    71205-063Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
    29300-215Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
    29300-216Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
    33342-058Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
    33342-057Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
    42291-342Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
    42291-343Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
    42658-141IRBESARTAN AND HYDROCHLOROTHIAZIDEIRBESARTAN AND HYDROCHLOROTHIAZIDE
    42658-142IRBESARTAN AND HYDROCHLOROTHIAZIDEIRBESARTAN AND HYDROCHLOROTHIAZIDE
    43547-331Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
    43547-330Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
    46708-442Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
    46708-444Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
    46708-443Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
    57297-414Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
    57297-413Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
    62332-053Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
    62332-051Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
    62332-052Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
    63187-981Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
    63187-653Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
    63629-7468Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
    64980-383Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
    64980-384Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
    64980-382Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
    65862-631Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
    65862-629Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
    65862-630Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
    70518-2013Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
    71335-1097Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
    70518-2247Irbesartan and HydrochlorothiazideIrbesartan and Hydrochlorothiazide
    0024-5855Avalideirbesartan and hydrochlorothiazide
    0024-5856Avalideirbesartan and hydrochlorothiazide
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