NDC 65862-835

Amlodipine, Valsartan and Hydrochlorothiazide

Amlodipine, Valsartan And Hydrochlorothiazide

Amlodipine, Valsartan 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 Amlodipine Besylate; Valsartan; Hydrochlorothiazide.

Product ID65862-835_80bcde84-2e68-492b-b4f7-d0cd0c15385f
NDC65862-835
Product TypeHuman Prescription Drug
Proprietary NameAmlodipine, Valsartan and Hydrochlorothiazide
Generic NameAmlodipine, Valsartan And Hydrochlorothiazide
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2017-12-19
Marketing CategoryANDA / ANDA
Application NumberANDA206180
Labeler NameAurobindo Pharma Limited
Substance NameAMLODIPINE BESYLATE; VALSARTAN; HYDROCHLOROTHIAZIDE
Active Ingredient Strength5 mg/1; mg/1; mg/1
Pharm ClassesCalcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin 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 65862-835-05

500 TABLET, FILM COATED in 1 BOTTLE (65862-835-05)
Marketing Start Date2017-12-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65862-835-05 [65862083505]

Amlodipine, Valsartan and Hydrochlorothiazide TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA206180
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-19

NDC 65862-835-90 [65862083590]

Amlodipine, Valsartan and Hydrochlorothiazide TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA206180
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-19

NDC 65862-835-30 [65862083530]

Amlodipine, Valsartan and Hydrochlorothiazide TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA206180
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-12-19

Drug Details

Active Ingredients

IngredientStrength
AMLODIPINE BESYLATE5 mg/1

OpenFDA Data

SPL SET ID:6fba5243-ee00-4825-a04a-321cb6b49c56
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 848151
  • 848145
  • 848131
  • 848140
  • 848135

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Amlodipine, Valsartan and Hydrochlorothiazide" or generic name "Amlodipine, Valsartan And Hydrochlorothiazide"

    NDCBrand NameGeneric Name
    13668-325Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and Hydrochlorothiazide
    13668-326Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and Hydrochlorothiazide
    13668-327Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and Hydrochlorothiazide
    13668-328Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and Hydrochlorothiazide
    13668-329Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and Hydrochlorothiazide
    57297-771Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and Hydrochlorothiazide
    57297-772Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and Hydrochlorothiazide
    57297-773Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and Hydrochlorothiazide
    57297-774Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and Hydrochlorothiazide
    57297-775Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and Hydrochlorothiazide
    65862-834Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and Hydrochlorothiazide
    65862-835Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and Hydrochlorothiazide
    65862-836Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and Hydrochlorothiazide
    65862-837Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and Hydrochlorothiazide
    65862-838Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and Hydrochlorothiazide
    68180-771Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and Hydrochlorothiazide
    68180-772Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and Hydrochlorothiazide
    68180-773Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and Hydrochlorothiazide
    68180-775Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and Hydrochlorothiazide
    68180-774Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and Hydrochlorothiazide
    70518-1220Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and Hydrochlorothiazide
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.