Sacubitril and valsartan

Sacubitril and valsartan · SACUBITRIL 24 mg/1; VALSARTAN 26 mg/1 · Tablet, Film Coated · Oral · Camber Pharmaceuticals, Inc.

NDC 31722-0673-60 · 60 TABLET, FILM COATED in 1 BOTTLE · ANDA · View full market →

The short version

18 companies list this market (plus 6 repackagers, which add no supply) — deep enough that no single failure threatens the supply. The generic price has fallen 60% in a year, to $0.4979 per unit — and generics that get this cheap tend to get abandoned rather than defended. The brand (Entresto) runs $11.59 per unit — 22× more. 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.

ⓘ How this was built

Data sources

FDA NDC Directory (openFDA) — labelers active in the last 30 days, repackagers classified from DailyMed SPL establishment roles
CMS NADAC — latest price vs the price in effect ~12 months earlier
FDA drug shortages and enforcement reports (openFDA)
FDA inspection classifications; DrugDashboards fragility score and 90-day shortage model

Method

Each sentence is a template that fires only when its condition holds in the data shown lower on this page: maker counts are distinct FDA labelers listing this molecule and dosage form in the last 30 days minus classified repackagers; the price trend compares the newest NADAC with the last price in effect at least 9 months earlier; shortage and recall sentences restate FDA rows for this drug's presentations (Class I/II, trailing 12 months); the plant sentence needs a MANUFACTURE-role establishment with a drug-quality OAI in 24 months; the verdict restates the fragility band; the risk sentence appears only when the model's probability is at least 1.5× the typical market. Nothing here is inferred beyond those rules.

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

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 weekly file (pharmacy acquisition, per unit)
CMS Part B ASP quarterly payment limit file + NDC–HCPCS crosswalk
CMS Maximum Fair Prices (IRA negotiated), matched on the NDC-9
CMS Part D Spending by Drug (annual, name-matched, gross incl. dispensing fee)
CMS Part D plan formulary/pricing files (SPUF): point-of-sale price across plans
VA FSS / Big4 federal contract prices (per package; per unit when the package is a count above 1)
CMS Federal Upper Limits + weighted AMP for the multiple-source drug group (monthly)
Texas DSHS annual WAC catalog, then Texas/California increase filings (per package)

Method

Each rung is the newest figure for this NDC from one price system, shown with its own unit — units differ, so compare a rung over time, not rung against rung. Part B is the file's payment limit (typically ASP+6%, WAC+3% for new drugs; sequestration is applied at claim level); when the NDC maps to several HCPCS codes the lowest code is shown and the count noted. Part D average is shown only on an exact brand-name match or a generic name with a single CMS row. FSS keeps the lowest active contract price, Big4 first, and skips 1¢ placeholders. The FUL belongs to the whole multiple-source group, so a brand NDC shows its generic group's ceiling. WAC is the Texas catalog's current list price, else the newest increase filing already in effect. To check a rung: open the named CMS/VA/state file for the date shown and find this NDC.

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

Pharmacies pay (NADAC)$0.4979per EAinvoice-surveyed acquisition cost · Aug 19, 2026
Medicaid ceiling, generic group (FUL)$1.09per TABweighted avg manufacturer price $0.6221 · Aug 1, 2026219% of what pharmacies pay — higher than 95% of drugs with this benchmark
List price (WAC, as filed)$228.46per packageTexas DSHS annual report · Hetero Labs Limited · 2026

Medicare Part D

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 00078-0659-20) — 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ⓘ

$5.23per unit

middle half $5.23–$5.23 · 393 plans · Apr 1, 2026

Est. net of rebatesⓘ

≈ $5.23

generic — rebates are minimal, so net ≈ gross

Coverage & restrictions

7%of plans cover it

tier 3 · prior auth 0% · step therapy 25% · qty limit 97%

*No drug-level rebate is public — the estimate applies a 25–40% brand range derived from MedPAC's program-wide aggregates to this drug's gross price. Tracked here for 10 quarters since 2024.

NADAC price per unit

ⓘ How this was built

Data sources

CMS NADAC weekly files (data.medicaid.gov), December 2024 onward
CMS NADAC per-year archive files, 2013 – November 2024, averaged per month
CMS Federal Upper Limit file — weighted average manufacturer price (WAMP) of the generic group (dashed line)

Method

One line, two regimes: before December 2024 each point is the average of that month's archived NADAC rows for this NDC; from December 2024 each point is a row from the weekly file, which CMS publishes only when the price changes, so the line holds flat until the next change and is extended to today when the last row is under 6 months old. Since the December 2024 file CMS computes generic NADAC as a 3-month moving average, so recent generic moves are smoothed and lag the market. The dashed WAMP is the manufacturer-side average for the whole multiple-source group, not this NDC alone. To check a point: open the NADAC file for that date on data.medicaid.gov and find this NDC.

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

12 price points · per EA · dashed = generic group's manufacturer avg (WAMP)Source: CMS NADAC — monthly means to Nov 2024, weekly file after

Estimated fill cost

#30 count

$14.94

#90 count

$44.81

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

Medicaid spend (2025)

ⓘ How this was built

Data sources

CMS State Drug Utilization Data (SDUD), data.medicaid.gov

Method

CMS's Medicaid Amount Reimbursed for this exact NDC, summed across every state and quarter of the period shown, fee-for-service and managed care together — the program's gross payment to pharmacies before manufacturer rebates (statutory rebates alone recover 23.1% or more of a brand's price). Cells CMS suppresses (fewer than 11 prescriptions in a state-quarter) are absent from the file, so totals for small drugs run low. The prescription count is CMS's Number of Prescriptions. To check: filter the SDUD file for the year to this NDC and sum the column.

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

$574,894

2,894 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

0● Low risk

Nothing here is signaling trouble: several labelers (repackagers excluded), no current shortage, no recent serious recalls, stable pricing. In drug supply, boring is the good outcome.

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 4, 2026

ⓘ How this was built

Data sources

FDA NDC Directory (openFDA) — labelers active in the last 30 days, repackagers excluded via DailyMed SPL roles
FDA drug shortages and enforcement reports (openFDA)
CMS NADAC weekly file — price now vs the price in effect a year ago

Method

Fragility v1 adds fixed points per condition for this NDC's molecule × dosage form: active labelers minus repackagers (1 → +30, 2 → +20, 3 → +10, 4–5 → +5; unknown count → 0); shortage (this NDC listed Current +25, another presentation of the same molecule/form +15, a resolution within 12 months +8); Class I/II recalls in 12 months (this NDC +15, same molecule/form +8); NADAC down 40%+ year over year +15 or 20%+ +8 (a Medicare-negotiated price cut also trips this); sterile injectable form or intravenous route +10; a to-be-discontinued FDA listing +10; capped at 100. Every point shows as a line above. To check: count the molecule's labelers in the NDC Directory, then look it up in FDA's shortage list, openFDA enforcement, and two NADAC files a year apart.

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

90-day shortage risk (model v2)

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

For scale: the typical drug’s chance is about 0.1% — this one is less than 1.5× that, which we treat as ordinary.

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

ⓘ How this was built

Data sources

FDA NDC Directory labeler counts, CMS NADAC price trend, openFDA shortages and enforcement, FDA inspection classifications, Wayback archive of FDA's shortage list (labels)

Method

A logistic regression over molecule × dosage-form markets, trained on a monthly grid of historical dates since 2019 with labels equal to whether a new FDA shortage posting appeared within the following 90 days; eight features knowable on each date (labeler count, sole-source flag, NADAC year-over-year change, Class I/II recalls, injectable form, discontinuation filings, open shortage episodes, recent OAI inspection). The probability shown is the model's output for today's feature values; the reasons are the features pushing this market's probability up, listed only when the feature actually holds here. Held-out performance and coefficients are on the fragility page.

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

Where it's made

Hetero Labs LimitedIndia
manufacture

Establishments this product's FDA label declares, with the role the label gives each (manufacture, API manufacture, pack, label, repack, analysis), located via FDA registration data. How we built this →

ⓘ How this was built

Data sources

DailyMed SPL labels (human prescription full release, monthly) — establishment DUNS and operations per label
FDA Drug Establishments Current Registration Site (DECRS) — DUNS to name and country
FDA Data Dashboard inspection classifications (Drug Quality Assurance)

Method

The label for this product's NDC-9 names each establishment and its operations; those DUNS numbers are matched to FDA's registration list for name and country. Only rows with a MANUFACTURE or API MANUFACTURE operation are places the drug is made; repack, relabel, pack, label and analysis rows are shown as what they are. The OAI badge means a drug-quality (GMP) inspection at that facility ended in Official Action Indicated within 24 months. Labels list plants, not volumes — a drug with two named plants may be made almost entirely at one. To check: open the label on DailyMed and its establishment section.

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

Regulatory

Application: ANDA213668
TE code: AB
Approval date: Jul 17, 2025
Patents / exclusivity: None on file

ⓘ How this was built

Data sources

FDA Orange Book data files — patent and exclusivity tables for application ANDA213668, edition retrieved 2026-08-24

Method

Rows are the Orange Book's patent and exclusivity listings for this NDA, de-duplicated across product numbers (the file repeats a listing for every strength). A listed patent is a claim the sponsor filed; it may cover a use rather than the molecule, may be challenged, and may be delisted — a listing is not proof a generic is blocked. Pediatric extensions appear as *PED rows. FDA blocks automated downloads of the Orange Book from cloud servers, so the edition can trail FDA's monthly release; the retrieval date above is the edition shown. To check: search the application number on FDA's Orange Book site.

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

Shortage history

ⓘ How this was built

Data sources

FDA drug shortages via openFDA (current file: Current, To Be Discontinued, and recently Resolved rows)
Internet Archive (Wayback) snapshots of FDA's shortage list since 2019, reconstructed into episodes
DrugDashboards Kaplan–Meier duration curves and conditional duration model

Method

Top rows are FDA's live listings whose package NDC is this product or another package of the same generic name and dosage form. openFDA drops resolved rows after about six months, so older episodes come from monthly Wayback snapshots of FDA's file, matched on the molecule with dosage-form words stripped (that matching can pull in other salts or forms of the same molecule — the presentation is shown so you can tell). 'Month N of a typical M' compares this episode's age with the Kaplan–Meier median for its form class (injectable, oral solid, other) over episodes since October 2019, open episodes censored; the resolution odds come from a model conditioned on the episode's age and reason. To check: FDA's drug shortage database, and web.archive.org for its history.

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

No FDA shortage listing for this drug's presentations in the current file, and no archived episode since 2019.

Recalls (this NDC)

ⓘ How this was built

Data sources

FDA drug enforcement reports via openFDA

Method

Enforcement reports whose product NDC list includes this exact package NDC, newest first, with FDA's classification (I = reasonable probability of serious harm, II = temporary or reversible harm, III = unlikely to cause harm) and the recall's current status. Reports for other packages of the same drug are not shown here; 275 of the last year's Class I/II reports carry no NDC at all and cannot be matched. To check: search the recall number on openFDA or FDA's enforcement reports.

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

No enforcement reports list this package NDC.

Labelers of Sacubitril and valsartan (Tablet, Film Coated)

24 labelers active in the last 30 days, of which 6 are repackagers; 0not seen for 30+ days. Keyed on FDA's generic-name string — other salts or forms of the molecule are separate rosters.

ⓘ How this was built

Data sources

FDA NDC Directory (openFDA), read daily since 2026-07-15 — labeler_name per package
DailyMed SPL establishment roles + name patterns → derived.labeler_kinds (repackager / manufacturer / unknown)

Method

One row per labeler that lists any package with this exact generic-name string and dosage form; strengths are combined. 'First seen' is the first daily snapshot that contained the labeler here (2026-07-15 for everything present at the start), 'last seen' the most recent; a labeler counts as active when seen in the last 30 days. Repackagers and relabelers are flagged when their own labels show only repack/relabel operations or their name matches a known repackager, and are excluded from every 'makers' count on this page. Listing is not volume: a labeler with a listed NDC may ship little or nothing. To check: search the generic name in FDA's NDC Directory and list the labelers.

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

Labeler	Strengths	First seen	Last seen
Aphena Pharma Solutions - Tennessee, LLCrepackager	SACUBITRIL 49 mg/1; VALSARTAN 51 mg/1; SACUBITRIL 97 mg/1; VALSARTAN 103 mg/1; SACUBITRIL 24 mg/1; VALSARTAN 26 mg/1	Jul 15, 2026	Sep 3, 2026
Ascend Laboratories, LLC	SACUBITRIL 97 mg/1; VALSARTAN 103 mg/1; SACUBITRIL 24 mg/1; VALSARTAN 26 mg/1; SACUBITRIL 49 mg/1; VALSARTAN 51 mg/1	Jul 15, 2026	Sep 3, 2026
AvKARErepackager	SACUBITRIL 97 mg/1; VALSARTAN 103 mg/1; SACUBITRIL 49 mg/1; VALSARTAN 51 mg/1; SACUBITRIL 24 mg/1; VALSARTAN 26 mg/1 (+1 more)	Jul 15, 2026	Sep 3, 2026
Novartis Pharmaceuticals Corporation	SACUBITRIL 49 mg/1; VALSARTAN 51 mg/1; SACUBITRIL 97 mg/1; VALSARTAN 103 mg/1; SACUBITRIL 24 mg/1; VALSARTAN 26 mg/1	Jul 15, 2026	Sep 3, 2026
Novugen Pharma (USA) LLC	SACUBITRIL 97 mg/1; VALSARTAN 103 mg/1; SACUBITRIL 24 mg/1; VALSARTAN 26 mg/1; SACUBITRIL 49 mg/1; VALSARTAN 51 mg/1	Jul 15, 2026	Sep 3, 2026
Synthon Chile Limitada	SACUBITRIL SODIUM 49 mg/1; VALSARTAN DISODIUM 51 mg/1; SACUBITRIL SODIUM 97 mg/1; VALSARTAN DISODIUM 103 mg/1; SACUBITRIL SODIUM 24 mg/1; VALSARTAN DISODIUM 26 mg/1 (+2 more)	Jul 15, 2026	Sep 3, 2026
Alembic Pharmaceuticals Inc.	SACUBITRIL 24 mg/1; VALSARTAN 26 mg/1; SACUBITRIL 49 mg/1; VALSARTAN 51 mg/1; SACUBITRIL 97 mg/1; VALSARTAN 103 mg/1	Jul 15, 2026	Sep 2, 2026
Alembic Pharmaceuticals Limited	SACUBITRIL 24 mg/1; VALSARTAN 26 mg/1; SACUBITRIL 49 mg/1; VALSARTAN 51 mg/1; SACUBITRIL 97 mg/1; VALSARTAN 103 mg/1	Jul 15, 2026	Sep 2, 2026
American Health Packagingrepackager	SACUBITRIL 24 mg/1; VALSARTAN 26 mg/1; SACUBITRIL 49 mg/1; VALSARTAN 51 mg/1; SACUBITRIL 97 mg/1; VALSARTAN 103 mg/1	Jul 15, 2026	Sep 2, 2026
Amneal Pharmaceuticals NY LLC	SACUBITRIL 24 mg/1; VALSARTAN 26 mg/1; SACUBITRIL 49 mg/1; VALSARTAN 51 mg/1; SACUBITRIL 97 mg/1; VALSARTAN 103 mg/1	Jul 15, 2026	Sep 2, 2026
ANI Pharmaceuticals, Inc.	SACUBITRIL 24 mg/1; VALSARTAN 26 mg/1; SACUBITRIL 49 mg/1; VALSARTAN 51 mg/1; SACUBITRIL 97 mg/1; VALSARTAN 103 mg/1	Jul 15, 2026	Sep 2, 2026
AvPAKrepackager	SACUBITRIL 24 mg/1; VALSARTAN 26 mg/1; SACUBITRIL 49 mg/1; VALSARTAN 51 mg/1; SACUBITRIL 97 mg/1; VALSARTAN 103 mg/1	Jul 15, 2026	Sep 2, 2026
Biocon Pharma Inc.	SACUBITRIL 24 mg/1; VALSARTAN 26 mg/1; SACUBITRIL 49 mg/1; VALSARTAN 51 mg/1; SACUBITRIL 97 mg/1; VALSARTAN 103 mg/1	Jul 15, 2026	Sep 2, 2026
Camber Pharmaceuticals, Inc.	SACUBITRIL 24 mg/1; VALSARTAN 26 mg/1; SACUBITRIL 49 mg/1; VALSARTAN 51 mg/1; SACUBITRIL 97 mg/1; VALSARTAN 103 mg/1	Jul 15, 2026	Sep 2, 2026
Coupler LLCrepackager	SACUBITRIL 24 mg/1; VALSARTAN 26 mg/1	Jul 15, 2026	Sep 2, 2026
Dr. Reddy's Laboratories Inc.	SACUBITRIL 24 mg/1; VALSARTAN 26 mg/1; SACUBITRIL 49 mg/1; VALSARTAN 51 mg/1; SACUBITRIL 97 mg/1; VALSARTAN 103 mg/1	Jul 15, 2026	Sep 2, 2026
Golden State Medical Supply, Inc.repackager	SACUBITRIL 24 mg/1; VALSARTAN 26 mg/1; SACUBITRIL 49 mg/1; VALSARTAN 51 mg/1; SACUBITRIL 97 mg/1; VALSARTAN 103 mg/1	Jul 15, 2026	Sep 2, 2026
Laurus Labs Limited	SACUBITRIL 24 mg/1; VALSARTAN 26 mg/1; SACUBITRIL 49 mg/1; VALSARTAN 51 mg/1; SACUBITRIL 97 mg/1; VALSARTAN 103 mg/1	Jul 15, 2026	Sep 2, 2026
Lupin Pharmaceuticals, Inc.	SACUBITRIL 24 mg/1; VALSARTAN 26 mg/1; SACUBITRIL 49 mg/1; VALSARTAN 51 mg/1; SACUBITRIL 97 mg/1; VALSARTAN 103 mg/1	Jul 15, 2026	Sep 2, 2026
Major Pharmaceuticals	SACUBITRIL 24 mg/1; VALSARTAN 26 mg/1; SACUBITRIL 49 mg/1; VALSARTAN 51 mg/1; SACUBITRIL 97 mg/1; VALSARTAN 103 mg/1	Jul 15, 2026	Sep 2, 2026
NorthStar RxLLC	SACUBITRIL 24 mg/1; VALSARTAN 26 mg/1; SACUBITRIL 49 mg/1; VALSARTAN 51 mg/1; SACUBITRIL 97 mg/1; VALSARTAN 103 mg/1	Jul 15, 2026	Sep 2, 2026
Novadoz Pharmaceuticals LLC	SACUBITRIL 24 mg/1; VALSARTAN 26 mg/1; SACUBITRIL 49 mg/1; VALSARTAN 51 mg/1; SACUBITRIL 97 mg/1; VALSARTAN 103 mg/1	Jul 15, 2026	Sep 2, 2026
Somerset Therapeutics, LLC	SACUBITRIL 24 mg/1; VALSARTAN 26 mg/1; SACUBITRIL 49 mg/1; VALSARTAN 51 mg/1; SACUBITRIL 97 mg/1; VALSARTAN 103 mg/1	Jul 15, 2026	Sep 2, 2026
Umedica Laboratories USA Inc.	SACUBITRIL 24 mg/1; VALSARTAN 26 mg/1; SACUBITRIL 49 mg/1; VALSARTAN 51 mg/1; SACUBITRIL 97 mg/1; VALSARTAN 103 mg/1	Aug 12, 2026	Sep 2, 2026

Roster from daily NDC Directory diffs — first/last seen dates start July 15, 2026.

Cite this page

DrugDashboards, "Sacubitril and valsartan — NDC 31722-0673-60," retrieved September 4, 2026, https://drugdashboards.com/drug/31722067360.

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