DrugDashboards

Irbesartan

Irbesartan · IRBESARTAN 75 mg/1 · Tablet · Oral · Solco Healthcare U.S., LLC

NDC 43547-0374-09 · 90 TABLET in 1 BOTTLE · ANDA · View full market →

The short version

17 companies supply this market — deep enough that no single failure threatens the supply. The price is down 28% over the past year, to $0.0827 per unit. One of its named manufacturing plants, Zhejiang Huahai Pharmaceutical Co., Ltd., failed FDA inspectionwithin the last two years — the agency’s most serious outcome. Put together: this looks like a healthy supply — the boring kind, which is exactly what you want.

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

One drug, every price

The same NDC has different prices depending on who is paying. Units differ between rungs — compare within a rung over time, not rung against rung, unless the units match.

ⓘ How this was built
Data sources
  • CMS NADAC (pharmacy acquisition, weekly)
  • CMS Part B ASP quarterly payment limits
  • CMS Maximum Fair Prices (IRA negotiated, NDC-level)
  • Medicare Part D Spending by Drug (data.cms.gov, name-matched)
  • VA FSS / Big4 federal contract prices (va.gov, twice monthly)
  • ACA Federal Upper Limits + weighted AMP (data.medicaid.gov, monthly)
  • California SB-17 WAC filings (list price, per package)
Method

Each rung is the newest figure for this NDC from one federal price system, shown with its own unit. Part D is matched by drug name because CMS publishes no NDCs there; it is gross spending, before confidential rebates.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

  • Pharmacies pay (NADAC)$0.0827per EAinvoice-surveyed acquisition cost · Aug 19, 2026
  • Part D plans paid (avg)$0.2762per dosage unitgross, before rebates — matched by drug name · 2024
  • Medicaid generic ceiling (FUL)$0.0827per TABweighted avg manufacturer price $0.0275 · Aug 1, 2026100% of what pharmacies pay — higher than 10% of drugs with this benchmark

Medicare Part D

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 33342-0047-10) — 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
$0.2198per unit
middle half $0.1268$0.3173 · 5,496 plans · Apr 1, 2026
Est. net of rebates
≈ $0.2198
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
100%of plans cover it
tier 1 · prior auth 0% · step therapy 0% · qty limit 68%

*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

$0$0.5$1.00Nov 2016Sep 2026$0.0827
117 price points · per EA · dashed = manufacturer avg (WAMP)Source: CMS NADAC

Estimated fill cost

#30 count
$2.48
#90 count
$7.44

Estimates: latest NADAC unit price × quantity. Pharmacy acquisition cost only — excludes dispensing fees, markup, and insurance terms.

Medicaid spend (2025)

$121,342
7,259 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

8Low risk

Some pressure is visible, but not much — here’s everything the score found to count.

  • price down 23% year over year+8

The score counts pressure that is already visible — fewer makers, shortages, recalls, falling prices. 0 means none of it; 100 means all of it at once. Recomputed daily · as of Sep 3, 2026

90-day shortage risk (model v2)

0.2%chance of a new FDA shortage posting for irbesartan (oral solid) in the next 90 days

OAI inspection at a producing facility (24 months) · 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
ANDA203071
TE code
AB
Approval date
Sep 27, 2012
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

  • Class II · CompletedJan 18, 2019
    Prinston Pharmaceutical IncCGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

Manufacturers of Irbesartan (Tablet)

LabelerStrengthFirst seenLast seen
A-S Medication SolutionsIRBESARTAN 300 mg/1Jul 15, 2026Sep 3, 2026
Aurobindo Pharma LimitedIRBESARTAN 75 mg/1Jul 15, 2026Sep 3, 2026
Aurobindo Pharma LimitedIRBESARTAN 150 mg/1Jul 15, 2026Sep 3, 2026
Bryant Ranch PrepackIRBESARTAN 75 mg/1Jul 15, 2026Sep 3, 2026
Bryant Ranch PrepackIRBESARTAN 150 mg/1Jul 15, 2026Sep 3, 2026
Bryant Ranch PrepackIRBESARTAN 300 mg/1Jul 15, 2026Sep 3, 2026
Camber Pharmaceuticals, Inc.IRBESARTAN 300 mg/1Jul 15, 2026Sep 3, 2026
Proficient Rx LPIRBESARTAN 150 mg/1Jul 15, 2026Sep 3, 2026
Remedyrepack Inc.IRBESARTAN 300 mg/1Jul 15, 2026Sep 3, 2026
Remedyrepack Inc.IRBESARTAN 150 mg/1Jul 15, 2026Sep 3, 2026
A-S Medication SolutionsIRBESARTAN 150 mg/1Jul 15, 2026Sep 2, 2026
Alembic Pharmaceuticals Inc.IRBESARTAN 300 mg/1Jul 15, 2026Sep 2, 2026
Alembic Pharmaceuticals Inc.IRBESARTAN 150 mg/1Jul 15, 2026Sep 2, 2026
Alembic Pharmaceuticals Inc.IRBESARTAN 75 mg/1Jul 15, 2026Sep 2, 2026
Alembic Pharmaceuticals LimitedIRBESARTAN 150 mg/1Jul 15, 2026Sep 2, 2026
Alembic Pharmaceuticals LimitedIRBESARTAN 75 mg/1Jul 15, 2026Sep 2, 2026
Alembic Pharmaceuticals LimitedIRBESARTAN 300 mg/1Jul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals LLCIRBESARTAN 300 mg/1Jul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals LLCIRBESARTAN 150 mg/1Jul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals LLCIRBESARTAN 75 mg/1Jul 15, 2026Sep 2, 2026
AvKAREIRBESARTAN 300 mg/1Jul 15, 2026Sep 2, 2026
AvKAREIRBESARTAN 150 mg/1Jul 15, 2026Sep 2, 2026
AvKAREIRBESARTAN 75 mg/1Jul 15, 2026Sep 2, 2026
AvPAKIRBESARTAN 300 mg/1Jul 15, 2026Sep 2, 2026
AvPAKIRBESARTAN 150 mg/1Jul 15, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.IRBESARTAN 75 mg/1Jul 15, 2026Sep 2, 2026
Chartwell RX, LLCIRBESARTAN 300 mg/1Jul 15, 2026Sep 2, 2026
Chartwell RX, LLCIRBESARTAN 150 mg/1Jul 15, 2026Sep 2, 2026
Chartwell RX, LLCIRBESARTAN 75 mg/1Jul 15, 2026Sep 2, 2026
direct rxIRBESARTAN 150 mg/1Jul 15, 2026Sep 2, 2026
direct rxIRBESARTAN 75 mg/1Jul 15, 2026Sep 2, 2026
direct rxIRBESARTAN 300 mg/1Jul 15, 2026Sep 2, 2026
Jubilant Cadista Pharmaceuticals Inc.IRBESARTAN 75 mg/1Jul 15, 2026Sep 2, 2026
Jubilant Cadista Pharmaceuticals Inc.IRBESARTAN 150 mg/1Jul 15, 2026Sep 2, 2026
Jubilant Cadista Pharmaceuticals Inc.IRBESARTAN 300 mg/1Jul 15, 2026Sep 2, 2026
Macleods Pharmaceuticals LimitedIRBESARTAN 300 mg/1Jul 15, 2026Sep 2, 2026
NorthStar RxLLCIRBESARTAN 75 mg/1Jul 15, 2026Sep 2, 2026
NorthStar RxLLCIRBESARTAN 150 mg/1Jul 15, 2026Sep 2, 2026
NorthStar RxLLCIRBESARTAN 300 mg/1Jul 15, 2026Sep 2, 2026
Preferred Pharmaceuticals Inc.IRBESARTAN 150 mg/1Jul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Irbesartan — NDC 43547-0374-09," retrieved September 3, 2026, https://drugdashboards.com/drug/43547037409.

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