United States · FDA National Drug Code directory

Amlodipine and Valsartan

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
46708-458_3fb35d37-f05c-44ff-be96-076adaa6da32
Product NDC
46708-458
Form
TABLET, FILM COATED
Composition / generic term
Amlodipine and Valsartan
Labeler
Alembic Pharmaceuticals Limited
Marketing category
ANDA
Marketing start / end (source format)
20161201
Source listing expiry
20261231

Source-listed ingredients

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

These values do not establish equivalence or a dose recommendation.

Packages

  • 100 TABLET, FILM COATED in 1 CARTON (46708-458-10) · 46708-458-10
  • 30 TABLET, FILM COATED in 1 BOTTLE (46708-458-30) · 46708-458-30
  • 100 TABLET, FILM COATED in 1 BOTTLE (46708-458-31) · 46708-458-31
  • 500 TABLET, FILM COATED in 1 BOTTLE (46708-458-71) · 46708-458-71
  • 90 TABLET, FILM COATED in 1 BOTTLE (46708-458-90) · 46708-458-90

Source and coverage

Open FDA National Drug Code directory

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.

Browse United States records →