DrugDashboards

Irbesartan and Hydrochlorothiazide

Irbesartan and Hydrochlorothiazide · IRBESARTAN 300 mg/1; HYDROCHLOROTHIAZIDE 25 mg/1 · Tablet, Film Coated · Oral · Aurobindo Pharma Limited

NDC 65862-0631-05 · 500 TABLET, FILM COATED in 1 BOTTLE · ANDA · View full market →

The short version

9 companies supply this market — a reasonable cushion if one runs into trouble.

The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.

Medicare Part D

No Medicare Part D plan in CMS's quarterly files lists this product. That usually means it is discontinued, a repackager's listing, or a product no plan has added to its formulary.

How Part D pricing works →

NADAC price per unit

No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.

Supply fragility

Not scored — fragility is computed for NADAC-priced NDCs.

90-day shortage risk (model v2)

0.1%chance of a new FDA shortage posting for irbesartan and hydrochlorothiazide (oral solid) in the next 90 days

sole-source market

For scale: the typical drug’s chance is about 0.1% — this one is in ordinary territory.

Backtested statistical model over the whole market, not this package alone. Model details →

Where it's made

Establishments this product's FDA label declares, located via FDA registration data. How we built this →

Regulatory

Application
ANDA203630
TE code
AB
Approval date
Feb 22, 2013
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of Irbesartan and Hydrochlorothiazide (Tablet, Film Coated)

LabelerStrengthFirst seenLast seen
Aurobindo Pharma LimitedIRBESARTAN 150 mg/1; HYDROCHLOROTHIAZIDE 12.5 mg/1Aug 20, 2026Sep 3, 2026
Aurobindo Pharma LimitedIRBESARTAN 300 mg/1; HYDROCHLOROTHIAZIDE 25 mg/1Aug 20, 2026Sep 3, 2026
Bryant Ranch PrepackIRBESARTAN 150 mg/1; HYDROCHLOROTHIAZIDE 12.5 mg/1Aug 26, 2026Sep 3, 2026
Sanofi Winthrop IndustireIRBESARTAN 300 mg/1; HYDROCHLOROTHIAZIDE 12.5 mg/1Aug 20, 2026Sep 3, 2026
Sanofi Winthrop IndustireIRBESARTAN 150 mg/1; HYDROCHLOROTHIAZIDE 12.5 mg/1Aug 20, 2026Sep 3, 2026
Alembic Pharmaceuticals Inc.IRBESARTAN 300 mg/1; HYDROCHLOROTHIAZIDE 25 mg/1Aug 26, 2026Sep 2, 2026
Aurobindo Pharma LimitedIRBESARTAN 300 mg/1; HYDROCHLOROTHIAZIDE 12.5 mg/1Aug 20, 2026Sep 2, 2026
Macleods Pharmaceuticals LimitedIRBESARTAN 150 mg/1; HYDROCHLOROTHIAZIDE 12.5 mg/1Aug 26, 2026Sep 2, 2026
Macleods Pharmaceuticals LimitedIRBESARTAN 300 mg/1; HYDROCHLOROTHIAZIDE 12.5 mg/1Aug 26, 2026Sep 2, 2026
Proficient Rx LPIRBESARTAN 150 mg/1; HYDROCHLOROTHIAZIDE 12.5 mg/1Aug 26, 2026Sep 2, 2026
Sanofi-Aventis U.S. LLCIRBESARTAN 300 mg/1; HYDROCHLOROTHIAZIDE 12.5 mg/1Aug 26, 2026Sep 2, 2026
Sanofi-Aventis U.S. LLCIRBESARTAN 150 mg/1; HYDROCHLOROTHIAZIDE 12.5 mg/1Aug 26, 2026Sep 2, 2026
Teva Pharmaceuticals USA, Inc.IRBESARTAN 300 mg/1; HYDROCHLOROTHIAZIDE 12.5 mg/1Aug 26, 2026Sep 2, 2026
Teva Pharmaceuticals USA, Inc.IRBESARTAN 150 mg/1; HYDROCHLOROTHIAZIDE 12.5 mg/1Aug 26, 2026Sep 2, 2026
Unichem Pharmaceuticals (USA), Inc.IRBESARTAN 300 mg/1; HYDROCHLOROTHIAZIDE 12.5 mg/1Aug 26, 2026Sep 2, 2026
Unichem Pharmaceuticals (USA), Inc.IRBESARTAN 150 mg/1; HYDROCHLOROTHIAZIDE 12.5 mg/1Aug 26, 2026Sep 2, 2026
Aurobindo Pharma LimitedIRBESARTAN 12.5 mg/1; HYDROCHLOROTHIAZIDE 300 mg/1Jul 22, 2026Aug 22, 2026
Bryant Ranch PrepackIRBESARTAN 12.5 mg/1; HYDROCHLOROTHIAZIDE 150 mg/1Jul 22, 2026Aug 22, 2026
Proficient Rx LPIRBESARTAN 12.5 mg/1; HYDROCHLOROTHIAZIDE 150 mg/1Jul 22, 2026Aug 22, 2026
Aurobindo Pharma LimitedIRBESARTAN 25 mg/1; HYDROCHLOROTHIAZIDE 300 mg/1Jul 22, 2026Aug 20, 2026
Alembic Pharmaceuticals Inc.IRBESARTAN 25 mg/1; HYDROCHLOROTHIAZIDE 300 mg/1Jul 22, 2026Aug 19, 2026
Aurobindo Pharma LimitedIRBESARTAN 12.5 mg/1; HYDROCHLOROTHIAZIDE 150 mg/1Jul 22, 2026Aug 19, 2026
Macleods Pharmaceuticals LimitedIRBESARTAN 12.5 mg/1; HYDROCHLOROTHIAZIDE 150 mg/1Jul 22, 2026Aug 19, 2026
Macleods Pharmaceuticals LimitedIRBESARTAN 12.5 mg/1; HYDROCHLOROTHIAZIDE 300 mg/1Jul 22, 2026Aug 19, 2026
Sanofi Winthrop IndustireIRBESARTAN 12.5 mg/1; HYDROCHLOROTHIAZIDE 300 mg/1Jul 22, 2026Aug 19, 2026
Sanofi Winthrop IndustireIRBESARTAN 12.5 mg/1; HYDROCHLOROTHIAZIDE 150 mg/1Jul 22, 2026Aug 19, 2026
Sanofi-Aventis U.S. LLCIRBESARTAN 12.5 mg/1; HYDROCHLOROTHIAZIDE 150 mg/1Jul 22, 2026Aug 19, 2026
Sanofi-Aventis U.S. LLCIRBESARTAN 12.5 mg/1; HYDROCHLOROTHIAZIDE 300 mg/1Jul 22, 2026Aug 19, 2026
Teva Pharmaceuticals USA, Inc.IRBESARTAN 12.5 mg/1; HYDROCHLOROTHIAZIDE 300 mg/1Jul 22, 2026Aug 19, 2026
Teva Pharmaceuticals USA, Inc.IRBESARTAN 12.5 mg/1; HYDROCHLOROTHIAZIDE 150 mg/1Jul 22, 2026Aug 19, 2026
Unichem Pharmaceuticals (USA), Inc.IRBESARTAN 12.5 mg/1; HYDROCHLOROTHIAZIDE 300 mg/1Jul 22, 2026Aug 19, 2026
Unichem Pharmaceuticals (USA), Inc.IRBESARTAN 12.5 mg/1; HYDROCHLOROTHIAZIDE 150 mg/1Jul 22, 2026Aug 19, 2026
Aurobindo Pharma LimitedHYDROCHLOROTHIAZIDE 12.5 mg/1; IRBESARTAN 150 mg/1Jul 15, 2026Jul 19, 2026
Bryant Ranch PrepackHYDROCHLOROTHIAZIDE 12.5 mg/1; IRBESARTAN 150 mg/1Jul 15, 2026Jul 19, 2026
Aurobindo Pharma LimitedHYDROCHLOROTHIAZIDE 12.5 mg/1; IRBESARTAN 300 mg/1Jul 15, 2026Jul 18, 2026
Aurobindo Pharma LimitedHYDROCHLOROTHIAZIDE 25 mg/1; IRBESARTAN 300 mg/1Jul 15, 2026Jul 16, 2026
Proficient Rx LPHYDROCHLOROTHIAZIDE 12.5 mg/1; IRBESARTAN 150 mg/1Jul 15, 2026Jul 16, 2026
Alembic Pharmaceuticals Inc.HYDROCHLOROTHIAZIDE 25 mg/1; IRBESARTAN 300 mg/1Jul 15, 2026Jul 15, 2026
Macleods Pharmaceuticals LimitedHYDROCHLOROTHIAZIDE 12.5 mg/1; IRBESARTAN 300 mg/1Jul 15, 2026Jul 15, 2026
Macleods Pharmaceuticals LimitedHYDROCHLOROTHIAZIDE 12.5 mg/1; IRBESARTAN 150 mg/1Jul 15, 2026Jul 15, 2026

Roster from daily NDC Directory diffs — first/last seen dates start July 2026.

Cite this page

DrugDashboards, "Irbesartan and Hydrochlorothiazide — NDC 65862-0631-05," retrieved September 3, 2026, https://drugdashboards.com/drug/65862063105.

Free to cite with attribution — see how the data is put together.