United States · FDA National Drug Code directory

AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE

A source-listed medicine record.

Factual source checks only. This page is not a clinically reviewed monograph. Historical or discontinued records may be included; listing does not confirm approval, current availability or pharmacy stock.

Medicine identity

Source reference
64380-197_6c98cab6-e7ba-42ba-adf9-71fa67c0a403
Product NDC
64380-197
Form
TABLET, FILM COATED
Composition / generic term
amlodipine besylate valsartan hydrochlorothiazide
Labeler
Strides Pharma Science Limited
Marketing category
ANDA
Marketing start / end (source format)
20220627
Source listing expiry
20261231

Source-listed ingredients

  • AMLODIPINE BESYLATE — 5 mg/1
  • VALSARTAN — 160 mg/1
  • HYDROCHLOROTHIAZIDE — 12.5 mg/1

These values do not establish equivalence or a dose recommendation.

Packages

  • 30 TABLET, FILM COATED in 1 BOTTLE (64380-197-01) · 64380-197-01
  • 90 TABLET, FILM COATED in 1 BOTTLE (64380-197-02) · 64380-197-02
  • 500 TABLET, FILM COATED in 1 BOTTLE (64380-197-03) · 64380-197-03

Source and coverage

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Snapshot retrieved: 2026-09-17. This is the acquisition date, not a medical review date.

Clinical information, images and comparisons appear only when separately reviewed for this record. Coverage may be incomplete. Ask a pharmacist or clinician about your treatment.

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