DrugDashboards

Amlodipine And Valsartan

Amlodipine And Valsartan · AMLODIPINE BESYLATE 5 mg/1; VALSARTAN 320 mg/1 · Tablet, Film Coated · Oral · Mylan Pharmaceuticals Inc.

NDC 00378-1723-93 · 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC · ANDA · View full market →

The short version

4 companies supply this market — a reasonable cushion if one runs into trouble. The price has fallen 37% in a year, to $0.3525 per unit — and generics that get this cheap tend to get abandoned rather than defended. 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)$0.3525per EAinvoice-surveyed acquisition cost · Aug 19, 2026
  • Part D point of sale (median)$0.8314per unitnegotiated price across 5,281 plans — before rebates · Apr 1, 2026
  • Medicaid generic ceiling (FUL)$0.5412per TABweighted avg manufacturer price $0.3093 · Aug 1, 2026154% of what pharmacies pay — higher than 81% of drugs with this benchmark

Medicare Part D

All Part D pricing →
ⓘ 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
$0.8314per unit
middle half $0.3460$1.55 · 5,281 plans · Apr 1, 2026
Est. net of rebates
≈ $0.8314
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
96%of plans cover it
tier 1 · prior auth 0% · step therapy 0% · qty limit 80%

*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$2.00$4.00$6.00Apr 2015Sep 2026$0.3525
138 price points · per EA · dashed = manufacturer avg (WAMP)Source: CMS NADAC

Estimated fill cost

#30 count
$10.57
#90 count
$31.72

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

Medicaid spend (2025)

$166,431
4,318 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

13Low risk

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

  • 4 active manufacturers+5
  • price down 36% 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)

0.1%chance of a new FDA shortage posting for amlodipine and valsartan (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 →

Regulatory

Application
ANDA090483
TE code
AB
Approval date
Mar 30, 2015
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

  • Class II · OngoingDec 4, 2018
    Mylan Laboratories Limited, (Nashik FDF)GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
  • Class II · OngoingDec 4, 2018
    Mylan Laboratories Limited, (Nashik FDF)GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
  • Class II · OngoingDec 4, 2018
    Mylan Laboratories Limited, (Nashik FDF)GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
  • Class II · OngoingDec 4, 2018
    Mylan Laboratories Limited, (Nashik FDF)GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
  • Class II · OngoingNov 20, 2018
    Mylan Pharmaceuticals Inc.CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
  • Class II · OngoingNov 20, 2018
    Mylan Pharmaceuticals Inc.CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
  • Class II · OngoingNov 20, 2018
    Mylan Pharmaceuticals Inc.CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.

Manufacturers of Amlodipine And Valsartan (Tablet, Film Coated)

LabelerStrengthFirst seenLast seen
Alembic Pharmaceuticals Inc.AMLODIPINE BESYLATE 10 mg/1; VALSARTAN 160 mg/1Jul 15, 2026Sep 2, 2026
Alembic Pharmaceuticals Inc.AMLODIPINE BESYLATE 10 mg/1; VALSARTAN 320 mg/1Jul 15, 2026Sep 2, 2026
Alembic Pharmaceuticals Inc.AMLODIPINE BESYLATE 5 mg/1; VALSARTAN 160 mg/1Jul 15, 2026Sep 2, 2026
Alembic Pharmaceuticals Inc.AMLODIPINE BESYLATE 5 mg/1; VALSARTAN 320 mg/1Jul 15, 2026Sep 2, 2026
Alembic Pharmaceuticals LimitedAMLODIPINE BESYLATE 10 mg/1; VALSARTAN 160 mg/1Jul 15, 2026Sep 2, 2026
Alembic Pharmaceuticals LimitedAMLODIPINE BESYLATE 5 mg/1; VALSARTAN 160 mg/1Jul 15, 2026Sep 2, 2026
Alembic Pharmaceuticals LimitedAMLODIPINE BESYLATE 5 mg/1; VALSARTAN 320 mg/1Jul 15, 2026Sep 2, 2026
Alembic Pharmaceuticals LimitedAMLODIPINE BESYLATE 10 mg/1; VALSARTAN 320 mg/1Jul 15, 2026Sep 2, 2026
Aurobindo Pharma LimitedAMLODIPINE BESYLATE 10 mg/1; VALSARTAN 320 mg/1Jul 15, 2026Sep 2, 2026
Aurobindo Pharma LimitedAMLODIPINE BESYLATE 5 mg/1; VALSARTAN 320 mg/1Jul 15, 2026Sep 2, 2026
Aurobindo Pharma LimitedAMLODIPINE BESYLATE 5 mg/1; VALSARTAN 160 mg/1Jul 15, 2026Sep 2, 2026
Aurobindo Pharma LimitedAMLODIPINE BESYLATE 10 mg/1; VALSARTAN 160 mg/1Jul 15, 2026Sep 2, 2026
Mylan Pharmaceuticals Inc.AMLODIPINE BESYLATE 5 mg/1; VALSARTAN 320 mg/1Jul 15, 2026Sep 2, 2026
Mylan Pharmaceuticals Inc.AMLODIPINE BESYLATE 10 mg/1; VALSARTAN 320 mg/1Jul 15, 2026Sep 2, 2026
Mylan Pharmaceuticals Inc.AMLODIPINE BESYLATE 10 mg/1; VALSARTAN 160 mg/1Jul 15, 2026Sep 2, 2026
Mylan Pharmaceuticals Inc.AMLODIPINE BESYLATE 5 mg/1; VALSARTAN 160 mg/1Jul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Amlodipine And Valsartan — NDC 00378-1723-93," retrieved September 3, 2026, https://drugdashboards.com/drug/00378172393.

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