United States · FDA National Drug Code directory

Irbesartan and 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
29300-216_a2e7c9d1-50c4-4a14-8dd5-8dfc6d63a29a
Product NDC
29300-216
Form
TABLET, FILM COATED
Composition / generic term
Irbesartan and Hydrochlorothiazide
Labeler
Unichem Pharmaceuticals (USA), Inc.
Marketing category
ANDA
Marketing start / end (source format)
20170919
Source listing expiry
20261231

Source-listed ingredients

  • IRBESARTAN — 300 mg/1
  • HYDROCHLOROTHIAZIDE — 12.5 mg/1

These values do not establish equivalence or a dose recommendation.

Packages

  • 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-216-10) · 29300-216-10
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-216-13) · 29300-216-13
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-216-19) · 29300-216-19

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 →