The short version
4 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.
Amlodipine and valsartan
Amlodipine and valsartan · AMLODIPINE BESYLATE 10 mg/1; VALSARTAN 320 mg/1 · Tablet, Film Coated · Oral · Aurobindo Pharma Limited
NDC 65862-0740-90 · 90 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 00378-1724-93) — 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ⓘ
$0.9664per unit
middle half $0.3794–$1.80 · 5,281 plans · Apr 1, 2026
Est. net of rebatesⓘ
≈ $0.9664
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
No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.
Estimated fill cost
WAC per package, as filed
$26.72
Reported to Texas DSHS · 2026 annual filing · Aurobindo Pharma Usa, Inc.
Manufacturer list price as filed — not what pharmacies actually pay after discounts.
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 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 →
Where it's made
- analysis · manufacture
Establishments this product's FDA label declares, located via FDA registration data. How we built this →
Regulatory
- Application
- ANDA206512
- TE code
- AB
- Approval date
- Apr 22, 2016
- Patents / exclusivity
- None on file
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
- Class II · OngoingDec 31, 2018Aurobindo Pharma USA Inc. — CGMP 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.
- Class II · OngoingDec 31, 2018Aurobindo Pharma USA Inc. — 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 31, 2018Aurobindo Pharma USA Inc. — CGMP 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.
- Class II · OngoingDec 31, 2018Aurobindo Pharma USA Inc. — CGMP 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.
- Class II · OngoingDec 31, 2018Aurobindo Pharma USA Inc. — CGMP 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 Amlodipine and valsartan (Tablet, Film Coated)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Alembic Pharmaceuticals Inc. | AMLODIPINE BESYLATE 10 mg/1; VALSARTAN 160 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Alembic Pharmaceuticals Inc. | AMLODIPINE BESYLATE 10 mg/1; VALSARTAN 320 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Alembic Pharmaceuticals Inc. | AMLODIPINE BESYLATE 5 mg/1; VALSARTAN 160 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Alembic Pharmaceuticals Inc. | AMLODIPINE BESYLATE 5 mg/1; VALSARTAN 320 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Alembic Pharmaceuticals Limited | AMLODIPINE BESYLATE 10 mg/1; VALSARTAN 160 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Alembic Pharmaceuticals Limited | AMLODIPINE BESYLATE 5 mg/1; VALSARTAN 160 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Alembic Pharmaceuticals Limited | AMLODIPINE BESYLATE 5 mg/1; VALSARTAN 320 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Alembic Pharmaceuticals Limited | AMLODIPINE BESYLATE 10 mg/1; VALSARTAN 320 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Aurobindo Pharma Limited | AMLODIPINE BESYLATE 10 mg/1; VALSARTAN 320 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Aurobindo Pharma Limited | AMLODIPINE BESYLATE 5 mg/1; VALSARTAN 320 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Aurobindo Pharma Limited | AMLODIPINE BESYLATE 5 mg/1; VALSARTAN 160 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Aurobindo Pharma Limited | AMLODIPINE BESYLATE 10 mg/1; VALSARTAN 160 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Mylan Pharmaceuticals Inc. | AMLODIPINE BESYLATE 5 mg/1; VALSARTAN 320 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Mylan Pharmaceuticals Inc. | AMLODIPINE BESYLATE 10 mg/1; VALSARTAN 320 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Mylan Pharmaceuticals Inc. | AMLODIPINE BESYLATE 10 mg/1; VALSARTAN 160 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Mylan Pharmaceuticals Inc. | AMLODIPINE BESYLATE 5 mg/1; VALSARTAN 160 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Amlodipine and valsartan — NDC 65862-0740-90," retrieved September 3, 2026, https://drugdashboards.com/drug/65862074090.
Free to cite with attribution — see how the data is put together.