NDC 65862-631

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 Aurobindo Pharma Limited. The primary component is Irbesartan; Hydrochlorothiazide.

Product ID65862-631_6107622c-d425-41a3-b748-4e8e1914a205
NDC65862-631
Product TypeHuman Prescription Drug
Proprietary NameIrbesartan and Hydrochlorothiazide
Generic NameIrbesartan And Hydrochlorothiazide
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2016-03-31
Marketing CategoryANDA / ANDA
Application NumberANDA203630
Labeler NameAurobindo Pharma Limited
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 Through2022-12-31

Packaging

NDC 65862-631-05

500 TABLET, FILM COATED in 1 BOTTLE (65862-631-05)
Marketing Start Date2016-03-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65862-631-99 [65862063199]

Irbesartan and Hydrochlorothiazide TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA203630
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-03-31

NDC 65862-631-30 [65862063130]

Irbesartan and Hydrochlorothiazide TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA203630
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-03-31

NDC 65862-631-90 [65862063190]

Irbesartan and Hydrochlorothiazide TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA203630
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-03-31

NDC 65862-631-05 [65862063105]

Irbesartan and Hydrochlorothiazide TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA203630
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-03-31

Drug Details

Active Ingredients

IngredientStrength
IRBESARTAN300 mg/1

OpenFDA Data

SPL SET ID:466dd0d2-9815-4c3e-b66b-d0732b3ba8e9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310792
  • 310793
  • 485471
    • UPC Code
  • 0365862629302
  • 0365862631305
  • 0365862630308

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