DrugDashboards

Hydralazine Hydrochloride

Hydralazine Hydrochloride · HYDRALAZINE HYDROCHLORIDE 25 mg/1 · Tablet · Oral · Glenmark Pharmaceuticals Inc., USA

NDC 68462-0342-01 · 100 TABLET in 1 BOTTLE · ANDA · View full market →

The short version

15 companies list this market (plus 14 repackagers, which add no supply) — deep enough that no single failure threatens the supply. The price is down 17% over the past year, to $0.0441 per unit.

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.

Medicare Part D

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 31722-0520-01) — 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ⓘ
$0.0712per unit
middle half $0.0527–$0.1153 · 5,496 plans · Apr 1, 2026
Est. net of rebatesⓘ
≈ $0.0712
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
100%of plans cover it
tier 1 · prior auth 0% · step therapy 0% · qty limit 0%

*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.

$0$0.05$0.1Nov 2013May 2018$0.0441
55 price points · per unit (archive) · last surveyed Invalid Date · dashed = generic group's manufacturer avg (WAMP)Source: CMS NADAC — monthly means to Nov 2024, weekly file after

Supply fragility

Not scored — fragility is computed for NDCs that have a NADAC price and a generic name.

90-day shortage risk (model v2)

0.1%chance of a new FDA shortage posting for hydralazine hydrochloride (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

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
ANDA090527
TE code
AA
Approval date
May 29, 2009
Patents / exclusivity
None on file
ⓘ How this was built
Data sources
  • FDA Orange Book data files — patent and exclusivity tables for application ANDA090527, 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.

Not on FDA's current shortage list. Archived episodes below.

Archived episodes (FDA list history via Wayback, 2019+)
  • Shortage ended — American Regent/Luitpold, 20mg/ml SDV ( NDC 0517 - 0901-25 ) (listed as “Hydralazine Hydrochloride Injection”)Mar 17, 2021 → Jun 29, 2021
  • Shortage ended — X-GEN Pharmaceuticals, Inc., 20 mg/mL per vial (NDC 39822-0500-4) (listed as “Hydralazine Hydrochloride Injection”)Sep 8, 2020 → Jun 29, 2021
  • Shortage ended — Fresenius Kabi USA, LLC, 20 mg per mL, SDV (NDC 63323-614-01) (listed as “Hydralazine Hydrochloride Injection”)Sep 8, 2020 → Jun 29, 2021
  • Shortage ended — Akorn Pharmaceuticals, 20 mg/mL, 1mL single dose vial (box of 10) (NDC 17478-934-01) (listed as “Hydralazine Hydrochloride Injection”)Sep 8, 2020 → Jun 29, 2021
  • Shortage ended — Akorn Pharmaceuticals, 20 mg/mL, 1mL single dose vial (box of 25) (NDC 17478-934-15) (listed as “Hydralazine Hydrochloride Injection”)Sep 8, 2020 → Jun 29, 2021
  • Shortage ended — Mylan Institutional, a Viatris company, 20 mg / 1 ml] 25PK (NDC 67457-291-01) (listed as “Hydralazine Hydrochloride Injection”)Sep 8, 2020 → Jun 29, 2021
  • In shortage now — American Regent/Luitpold, 20mg/ml SDV ( NDC 0517 - 0901-25 ) (listed as “Hydralazine Hydrochloride Injection, USP”)Mar 17, 2021 → last seen Apr 12, 2021
  • In shortage now — Akorn Pharmaceuticals, 20 mg/mL, 1mL single dose vial (box of 10) (NDC 17478-934-01) (listed as “Hydralazine Hydrochloride Injection, USP”)Sep 8, 2020 → last seen Apr 12, 2021

Showing 8 of 12 archived episodes.

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 Hydralazine Hydrochloride (Tablet)

29 labelers active in the last 30 days, of which 14 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.

LabelerStrengthsFirst seenLast seen
A-S Medication SolutionsrepackagerHYDRALAZINE HYDROCHLORIDE 50 mg/1; HYDRALAZINE HYDROCHLORIDE 25 mg/1Jul 15, 2026Sep 3, 2026
Bryant Ranch PrepackrepackagerHYDRALAZINE HYDROCHLORIDE 25 mg/1; HYDRALAZINE HYDROCHLORIDE 50 mg/1; HYDRALAZINE HYDROCHLORIDE 100 mg/1 (+1 more)Jul 15, 2026Sep 3, 2026
Cardinal Health 107, LLCrepackagerHYDRALAZINE HYDROCHLORIDE 50 mg/1; HYDRALAZINE HYDROCHLORIDE 25 mg/1Jul 15, 2026Sep 3, 2026
Coupler LLCrepackagerHYDRALAZINE HYDROCHLORIDE 10 mg/1; HYDRALAZINE HYDROCHLORIDE 25 mg/1; HYDRALAZINE HYDROCHLORIDE 50 mg/1Jul 15, 2026Sep 3, 2026
Remedyrepack Inc.repackagerHYDRALAZINE HYDROCHLORIDE 25 mg/1; HYDRALAZINE HYDROCHLORIDE 10 mg/1; HYDRALAZINE HYDROCHLORIDE 100 mg/1 (+1 more)Jul 15, 2026Sep 3, 2026
American Health PackagingrepackagerHYDRALAZINE HYDROCHLORIDE 10 mg/1; HYDRALAZINE HYDROCHLORIDE 25 mg/1; HYDRALAZINE HYDROCHLORIDE 50 mg/1Jul 15, 2026Sep 2, 2026
Aphena Pharma Solutions - Tennessee, LLCrepackagerHYDRALAZINE HYDROCHLORIDE 50 mg/1; HYDRALAZINE HYDROCHLORIDE 25 mg/1; HYDRALAZINE HYDROCHLORIDE 100 mg/1Jul 15, 2026Sep 2, 2026
Ascend Laboratories, LLCHYDRALAZINE HYDROCHLORIDE 10 mg/1; HYDRALAZINE HYDROCHLORIDE 100 mg/1; HYDRALAZINE HYDROCHLORIDE 25 mg/1 (+1 more)Jul 15, 2026Sep 2, 2026
Cadila Pharmaceuticals LimitedHYDRALAZINE HYDROCHLORIDE 100 mg/1; HYDRALAZINE HYDROCHLORIDE 25 mg/1; HYDRALAZINE HYDROCHLORIDE 50 mg/1Jul 15, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.HYDRALAZINE HYDROCHLORIDE 10 mg/1; HYDRALAZINE HYDROCHLORIDE 100 mg/1; HYDRALAZINE HYDROCHLORIDE 25 mg/1 (+1 more)Jul 15, 2026Sep 2, 2026
Exelan Pharmaceuticals Inc.HYDRALAZINE HYDROCHLORIDE 10 mg/1; HYDRALAZINE HYDROCHLORIDE 100 mg/1; HYDRALAZINE HYDROCHLORIDE 25 mg/1 (+1 more)Jul 15, 2026Sep 2, 2026
Glenmark Pharmaceuticals Inc., USAHYDRALAZINE HYDROCHLORIDE 10 mg/1; HYDRALAZINE HYDROCHLORIDE 100 mg/1; HYDRALAZINE HYDROCHLORIDE 25 mg/1 (+1 more)Jul 15, 2026Sep 2, 2026
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.HYDRALAZINE HYDROCHLORIDE 10 mg/1; HYDRALAZINE HYDROCHLORIDE 100 mg/1; HYDRALAZINE HYDROCHLORIDE 25 mg/1 (+1 more)Jul 15, 2026Sep 2, 2026
Macleods Pharmaceuticals LimitedHYDRALAZINE HYDROCHLORIDE 10 mg/1; HYDRALAZINE HYDROCHLORIDE 100 mg/1; HYDRALAZINE HYDROCHLORIDE 25 mg/1 (+1 more)Jul 15, 2026Sep 2, 2026
Major PharmaceuticalsHYDRALAZINE HYDROCHLORIDE 10 mg/1; HYDRALAZINE HYDROCHLORIDE 100 mg/1; HYDRALAZINE HYDROCHLORIDE 25 mg/1 (+1 more)Jul 15, 2026Sep 2, 2026
Modavar Pharmaceuticals LLCHYDRALAZINE HYDROCHLORIDE 100 mg/1; HYDRALAZINE HYDROCHLORIDE 25 mg/1; HYDRALAZINE HYDROCHLORIDE 50 mg/1Jul 15, 2026Sep 2, 2026
Mylan Institutional Inc.HYDRALAZINE HYDROCHLORIDE 10 mg/1; HYDRALAZINE HYDROCHLORIDE 25 mg/1; HYDRALAZINE HYDROCHLORIDE 50 mg/1Jul 15, 2026Sep 2, 2026
NCS HealthCare of KY, LLC dba Vangard LabsrepackagerHYDRALAZINE HYDROCHLORIDE 100 mg/1Jul 15, 2026Sep 2, 2026
Nivagen Pharmaceuticals, Inc.HYDRALAZINE HYDROCHLORIDE 100 mg/1; HYDRALAZINE HYDROCHLORIDE 25 mg/1; HYDRALAZINE HYDROCHLORIDE 50 mg/1Jul 15, 2026Sep 2, 2026
Northwind Health Company, LLCrepackagerHYDRALAZINE HYDROCHLORIDE 25 mg/1Jul 15, 2026Sep 2, 2026
NuCare Pharmaceuticals, Inc.repackagerHYDRALAZINE HYDROCHLORIDE 10 mg/1; HYDRALAZINE HYDROCHLORIDE 50 mg/1Jul 15, 2026Sep 2, 2026
NuCare Pharmaceuticals,Inc.repackagerHYDRALAZINE HYDROCHLORIDE 100 mg/1Jul 15, 2026Sep 2, 2026
Preferred Pharmaceuticals, Inc.repackagerHYDRALAZINE HYDROCHLORIDE 100 mg/1Jul 15, 2026Sep 2, 2026
Proficient Rx LPrepackagerHYDRALAZINE HYDROCHLORIDE 10 mg/1; HYDRALAZINE HYDROCHLORIDE 100 mg/1; HYDRALAZINE HYDROCHLORIDE 25 mg/1 (+1 more)Jul 15, 2026Sep 2, 2026
Radha Pharmaceuticals, Inc.HYDRALAZINE HYDROCHLORIDE 10 mg/1; HYDRALAZINE HYDROCHLORIDE 100 mg/1; HYDRALAZINE HYDROCHLORIDE 25 mg/1 (+1 more)Jul 15, 2026Sep 2, 2026
Safecor Health, LLCrepackagerHYDRALAZINE HYDROCHLORIDE 10 mg/1; HYDRALAZINE HYDROCHLORIDE 25 mg/1; HYDRALAZINE HYDROCHLORIDE 50 mg/1Jul 15, 2026Sep 2, 2026
ScieGen Pharmaceuticals, Inc.HYDRALAZINE HYDROCHLORIDE 10 mg/1; HYDRALAZINE HYDROCHLORIDE 100 mg/1; HYDRALAZINE HYDROCHLORIDE 25 mg/1 (+1 more)Jul 15, 2026Sep 2, 2026
Strides Pharma Science LimitedHYDRALAZINE HYDROCHLORIDE 10 mg/1; HYDRALAZINE HYDROCHLORIDE 100 mg/1; HYDRALAZINE HYDROCHLORIDE 25 mg/1 (+1 more)Jul 15, 2026Sep 2, 2026
Teva Pharmaceuticals USA, Inc.HYDRALAZINE HYDROCHLORIDE 10 mg/1; HYDRALAZINE HYDROCHLORIDE 100 mg/1; HYDRALAZINE HYDROCHLORIDE 25 mg/1 (+1 more)Jul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Hydralazine Hydrochloride — NDC 68462-0342-01," retrieved September 4, 2026, https://drugdashboards.com/drug/68462034201.

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