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.
Irbesartan and Hydrochlorothiazide
Irbesartan and Hydrochlorothiazide · IRBESARTAN 300 mg/1; HYDROCHLOROTHIAZIDE 12.5 mg/1 · Tablet, Film Coated · Oral · Aurobindo Pharma Limited
NDC 65862-0630-05 · 500 TABLET, FILM COATED in 1 BOTTLE · ANDA · View full market →
Medicare Part D
All Part D pricing →Matched to CMS's representative package for this drug (NDC 00024-5856-30) — same generic, strength, and dosage form. CMS prices one NDC per drug concept, not every package.
ⓘ How this was built
Data sources
- CMS quarterly Prescription Drug Plan Formulary & Pricing files (SPUF)
Method
Negotiated 30-day point-of-sale unit prices and formulary terms aggregated across every unsuppressed Part D and MA-PD plan for the quarter shown. Point of sale means gross of confidential rebates. CMS publishes one representative NDC per drug concept (RxCUI) rather than every package, so these figures come from CMS's representative package for the same drug — matched on generic name, strength, and dosage form. Estimated from MedPAC's program-wide rebate aggregates (June 2023: DIR = 29% of gross Part D spending; brand rebates ≈ 25–40% of gross, generics minimal). Actual rebates are confidential and vary widely by drug — this is a range, not a fact about this drug.
Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.
Plans pay at point of saleⓘ
$9.91per unit
middle half $9.91–$9.91 · 2 plans · Apr 1, 2026
Est. net of rebatesⓘ
≈ $9.91
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
0%of plans cover it
tier 1 · prior auth 0% · step therapy 0% · qty limit 100%
*No drug-level rebate is public — the estimate applies MedPAC's program-wide brand rebate range to this drug's gross price. Tracked here for 10 quarters since 2024.
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
- analysis · manufacture
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)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Aurobindo Pharma Limited | IRBESARTAN 150 mg/1; HYDROCHLOROTHIAZIDE 12.5 mg/1 | Aug 20, 2026 | Sep 3, 2026 |
| Aurobindo Pharma Limited | IRBESARTAN 300 mg/1; HYDROCHLOROTHIAZIDE 25 mg/1 | Aug 20, 2026 | Sep 3, 2026 |
| Bryant Ranch Prepack | IRBESARTAN 150 mg/1; HYDROCHLOROTHIAZIDE 12.5 mg/1 | Aug 26, 2026 | Sep 3, 2026 |
| Sanofi Winthrop Industire | IRBESARTAN 300 mg/1; HYDROCHLOROTHIAZIDE 12.5 mg/1 | Aug 20, 2026 | Sep 3, 2026 |
| Sanofi Winthrop Industire | IRBESARTAN 150 mg/1; HYDROCHLOROTHIAZIDE 12.5 mg/1 | Aug 20, 2026 | Sep 3, 2026 |
| Alembic Pharmaceuticals Inc. | IRBESARTAN 300 mg/1; HYDROCHLOROTHIAZIDE 25 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Aurobindo Pharma Limited | IRBESARTAN 300 mg/1; HYDROCHLOROTHIAZIDE 12.5 mg/1 | Aug 20, 2026 | Sep 2, 2026 |
| Macleods Pharmaceuticals Limited | IRBESARTAN 150 mg/1; HYDROCHLOROTHIAZIDE 12.5 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Macleods Pharmaceuticals Limited | IRBESARTAN 300 mg/1; HYDROCHLOROTHIAZIDE 12.5 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Proficient Rx LP | IRBESARTAN 150 mg/1; HYDROCHLOROTHIAZIDE 12.5 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Sanofi-Aventis U.S. LLC | IRBESARTAN 300 mg/1; HYDROCHLOROTHIAZIDE 12.5 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Sanofi-Aventis U.S. LLC | IRBESARTAN 150 mg/1; HYDROCHLOROTHIAZIDE 12.5 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Teva Pharmaceuticals USA, Inc. | IRBESARTAN 300 mg/1; HYDROCHLOROTHIAZIDE 12.5 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Teva Pharmaceuticals USA, Inc. | IRBESARTAN 150 mg/1; HYDROCHLOROTHIAZIDE 12.5 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Unichem Pharmaceuticals (USA), Inc. | IRBESARTAN 300 mg/1; HYDROCHLOROTHIAZIDE 12.5 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Unichem Pharmaceuticals (USA), Inc. | IRBESARTAN 150 mg/1; HYDROCHLOROTHIAZIDE 12.5 mg/1 | Aug 26, 2026 | Sep 2, 2026 |
| Aurobindo Pharma Limited | IRBESARTAN 12.5 mg/1; HYDROCHLOROTHIAZIDE 300 mg/1 | Jul 22, 2026 | Aug 22, 2026 |
| Bryant Ranch Prepack | IRBESARTAN 12.5 mg/1; HYDROCHLOROTHIAZIDE 150 mg/1 | Jul 22, 2026 | Aug 22, 2026 |
| Proficient Rx LP | IRBESARTAN 12.5 mg/1; HYDROCHLOROTHIAZIDE 150 mg/1 | Jul 22, 2026 | Aug 22, 2026 |
| Aurobindo Pharma Limited | IRBESARTAN 25 mg/1; HYDROCHLOROTHIAZIDE 300 mg/1 | Jul 22, 2026 | Aug 20, 2026 |
| Alembic Pharmaceuticals Inc. | IRBESARTAN 25 mg/1; HYDROCHLOROTHIAZIDE 300 mg/1 | Jul 22, 2026 | Aug 19, 2026 |
| Aurobindo Pharma Limited | IRBESARTAN 12.5 mg/1; HYDROCHLOROTHIAZIDE 150 mg/1 | Jul 22, 2026 | Aug 19, 2026 |
| Macleods Pharmaceuticals Limited | IRBESARTAN 12.5 mg/1; HYDROCHLOROTHIAZIDE 150 mg/1 | Jul 22, 2026 | Aug 19, 2026 |
| Macleods Pharmaceuticals Limited | IRBESARTAN 12.5 mg/1; HYDROCHLOROTHIAZIDE 300 mg/1 | Jul 22, 2026 | Aug 19, 2026 |
| Sanofi Winthrop Industire | IRBESARTAN 12.5 mg/1; HYDROCHLOROTHIAZIDE 300 mg/1 | Jul 22, 2026 | Aug 19, 2026 |
| Sanofi Winthrop Industire | IRBESARTAN 12.5 mg/1; HYDROCHLOROTHIAZIDE 150 mg/1 | Jul 22, 2026 | Aug 19, 2026 |
| Sanofi-Aventis U.S. LLC | IRBESARTAN 12.5 mg/1; HYDROCHLOROTHIAZIDE 150 mg/1 | Jul 22, 2026 | Aug 19, 2026 |
| Sanofi-Aventis U.S. LLC | IRBESARTAN 12.5 mg/1; HYDROCHLOROTHIAZIDE 300 mg/1 | Jul 22, 2026 | Aug 19, 2026 |
| Teva Pharmaceuticals USA, Inc. | IRBESARTAN 12.5 mg/1; HYDROCHLOROTHIAZIDE 300 mg/1 | Jul 22, 2026 | Aug 19, 2026 |
| Teva Pharmaceuticals USA, Inc. | IRBESARTAN 12.5 mg/1; HYDROCHLOROTHIAZIDE 150 mg/1 | Jul 22, 2026 | Aug 19, 2026 |
| Unichem Pharmaceuticals (USA), Inc. | IRBESARTAN 12.5 mg/1; HYDROCHLOROTHIAZIDE 300 mg/1 | Jul 22, 2026 | Aug 19, 2026 |
| Unichem Pharmaceuticals (USA), Inc. | IRBESARTAN 12.5 mg/1; HYDROCHLOROTHIAZIDE 150 mg/1 | Jul 22, 2026 | Aug 19, 2026 |
| Aurobindo Pharma Limited | HYDROCHLOROTHIAZIDE 12.5 mg/1; IRBESARTAN 150 mg/1 | Jul 15, 2026 | Jul 19, 2026 |
| Bryant Ranch Prepack | HYDROCHLOROTHIAZIDE 12.5 mg/1; IRBESARTAN 150 mg/1 | Jul 15, 2026 | Jul 19, 2026 |
| Aurobindo Pharma Limited | HYDROCHLOROTHIAZIDE 12.5 mg/1; IRBESARTAN 300 mg/1 | Jul 15, 2026 | Jul 18, 2026 |
| Aurobindo Pharma Limited | HYDROCHLOROTHIAZIDE 25 mg/1; IRBESARTAN 300 mg/1 | Jul 15, 2026 | Jul 16, 2026 |
| Proficient Rx LP | HYDROCHLOROTHIAZIDE 12.5 mg/1; IRBESARTAN 150 mg/1 | Jul 15, 2026 | Jul 16, 2026 |
| Alembic Pharmaceuticals Inc. | HYDROCHLOROTHIAZIDE 25 mg/1; IRBESARTAN 300 mg/1 | Jul 15, 2026 | Jul 15, 2026 |
| Macleods Pharmaceuticals Limited | HYDROCHLOROTHIAZIDE 12.5 mg/1; IRBESARTAN 300 mg/1 | Jul 15, 2026 | Jul 15, 2026 |
| Macleods Pharmaceuticals Limited | HYDROCHLOROTHIAZIDE 12.5 mg/1; IRBESARTAN 150 mg/1 | Jul 15, 2026 | Jul 15, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Irbesartan and Hydrochlorothiazide — NDC 65862-0630-05," retrieved September 3, 2026, https://drugdashboards.com/drug/65862063005.
Free to cite with attribution — see how the data is put together.