Labetalol Hydrochloride

Labetalol Hydrochloride · LABETALOL HYDROCHLORIDE 300 mg/1 · Tablet, Film Coated · Oral · Innogenix, Inc.

NDC 71247-0130-01 · 100 TABLET, FILM COATED in 1 BOTTLE · ANDA · View full market →

The short version

13 companies list this market (plus 13 repackagers, which add no supply) — deep enough that no single failure threatens the supply. The price has held steady around $0.2041 per unit over the past year. 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)$0.2041per EAinvoice-surveyed acquisition cost · Feb 18, 2026
Medicaid ceiling, generic group (FUL)$0.2004per TABweighted avg manufacturer price $0.0936 · Apr 1, 202598% of what pharmacies pay — a deeper discount than 95% of drugs with this benchmark

Medicare Part D

No Medicare Part D plan in CMS's quarterly files lists this product. That usually means it is discontinued, a repackager's listing, or a product no plan has added to its formulary.

How Part D pricing works →

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.

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

Estimated fill cost

#30 count

$6.12

#90 count

$18.37

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.

$985

36 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 labetalol hydrochloride (oral solid) in the next 90 days

price up 2% YoY

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.

Regulatory

Application: ANDA075215
TE code: AB
Approval date: Jul 29, 1999
Patents / exclusivity: None on file

ⓘ How this was built

Data sources

FDA Orange Book data files — patent and exclusivity tables for application ANDA075215, 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+)

Planned discontinuation — Actavis LLC, an indirect wholly owned subsidiary of Teva Pharmaceuticals USA, Inc., Tablet, 200 mg (NDC 0591-0606-05) (listed as “Labetalol Hydrochloride Tablet”)Mar 11, 2024 → last seen Feb 26, 2025
Planned discontinuation — Actavis LLC, an indirect wholly owned subsidiary of Teva Pharmaceuticals USA, Inc., Tablet, 200 mg (NDC 0591-0606-01) (listed as “Labetalol Hydrochloride Tablet”)Mar 11, 2024 → last seen Feb 26, 2025
Planned discontinuation — Actavis LLC, an indirect wholly owned subsidiary of Teva Pharmaceuticals USA, Inc., Tablet, 100 mg (NDC 0591-0605-01) (listed as “Labetalol Hydrochloride Tablet”)Mar 11, 2024 → last seen Feb 26, 2025
Planned discontinuation — Actavis LLC, an indirect wholly owned subsidiary of Teva Pharmaceuticals USA, Inc., Tablet, 100 mg (NDC 0591-0605-05) (listed as “Labetalol Hydrochloride Tablet”)Mar 11, 2024 → last seen Feb 26, 2025
Planned discontinuation — Actavis LLC, an indirect wholly owned subsidiary of Teva Pharmaceuticals USA, Inc., Tablet, 300 mg (NDC 0591-0607-01) (listed as “Labetalol Hydrochloride Tablet”)Mar 11, 2024 → last seen Feb 26, 2025
Shortage ended — Gland Pharma Limited, 5 mg/mL, 40 mL vial (NDC 72266-103-01) (listed as “Labetalol Hydrochloride Injection”)Mar 2, 2017 → Dec 9, 2020
Shortage ended — Hikma Pharmaceuticals USA, Inc. (formerly West-Ward), 5 mg/mL, 40 mL multidose vial (NDC 0143-9623-01) (listed as “Labetalol Hydrochloride Injection”)Mar 2, 2017 → Dec 9, 2020
Shortage ended — Akorn Pharmaceuticals, 5mg/mL (100mg/20mL) Multi-Dose vial (NDC 17478-420-20) (listed as “Labetalol Hydrochloride Injection”)Mar 2, 2017 → Dec 9, 2020

Showing 8 of 16 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 Labetalol Hydrochloride (Tablet, Film Coated)

26 labelers active in the last 30 days, of which 13 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
A-S Medication Solutionsrepackager	LABETALOL HYDROCHLORIDE 100 mg/1; LABETALOL HYDROCHLORIDE 200 mg/1; LABETALOL HYDROCHLORIDE 300 mg/1	Jul 15, 2026	Sep 3, 2026
Actavis Pharma, Inc.	LABETALOL HYDROCHLORIDE 100 mg/1; LABETALOL HYDROCHLORIDE 200 mg/1	Jul 15, 2026	Sep 3, 2026
Advagen Pharma Ltd	LABETALOL HYDROCHLORIDE 300 mg/1; LABETALOL HYDROCHLORIDE 100 mg/1; LABETALOL HYDROCHLORIDE 200 mg/1	Jul 15, 2026	Sep 3, 2026
Bryant Ranch Prepackrepackager	LABETALOL 100 mg/1; LABETALOL 200 mg/1; LABETALOL 300 mg/1 (+3 more)	Jul 15, 2026	Sep 3, 2026
Cardinal Health 107, LLCrepackager	LABETALOL HYDROCHLORIDE 200 mg/1; LABETALOL HYDROCHLORIDE 300 mg/1; LABETALOL HYDROCHLORIDE 100 mg/1	Jul 15, 2026	Sep 3, 2026
Method Pharmaceuticals, LLC	LABETALOL 300 mg/1; LABETALOL 100 mg/1; LABETALOL 200 mg/1	Jul 15, 2026	Sep 3, 2026
Proficient Rx LPrepackager	LABETALOL HYDROCHLORIDE 100 mg/1	Jul 15, 2026	Sep 3, 2026
St. Mary's Medical Park Pharmacyrepackager	LABETALOL HYDROCHLORIDE 100 mg/1	Jul 15, 2026	Sep 3, 2026
American Health Packagingrepackager	LABETALOL HYDROCHLORIDE 100 mg/1; LABETALOL HYDROCHLORIDE 200 mg/1; LABETALOL HYDROCHLORIDE 300 mg/1	Jul 15, 2026	Sep 2, 2026
Biocon Pharma Inc.	LABETALOL HYDROCHLORIDE 100 mg/1; LABETALOL HYDROCHLORIDE 200 mg/1; LABETALOL HYDROCHLORIDE 300 mg/1 (+1 more)	Jul 15, 2026	Sep 2, 2026
BluePoint Laboratories Inc.	LABETALOL HYDROCHLORIDE 100 mg/1; LABETALOL HYDROCHLORIDE 200 mg/1; LABETALOL HYDROCHLORIDE 300 mg/1	Jul 15, 2026	Sep 2, 2026
Cadila Pharmaceuticals Limited	LABETALOL HYDROCHLORIDE 100 mg/1; LABETALOL HYDROCHLORIDE 200 mg/1; LABETALOL HYDROCHLORIDE 300 mg/1	Jul 15, 2026	Sep 2, 2026
Golden State Medical Supply, Inc.repackager	LABETALOL HYDROCHLORIDE 100 mg/1; LABETALOL HYDROCHLORIDE 200 mg/1; LABETALOL HYDROCHLORIDE 300 mg/1	Jul 15, 2026	Sep 2, 2026
Innogenix, Inc.	LABETALOL HYDROCHLORIDE 100 mg/1; LABETALOL HYDROCHLORIDE 200 mg/1; LABETALOL HYDROCHLORIDE 300 mg/1	Jul 15, 2026	Sep 2, 2026
Macleods Pharmaceuticals Limited	LABETALOL HYDROCHLORIDE 100 mg/1; LABETALOL HYDROCHLORIDE 200 mg/1; LABETALOL HYDROCHLORIDE 300 mg/1	Jul 15, 2026	Sep 2, 2026
Major Pharmaceuticals	LABETALOL HYDROCHLORIDE 100 mg/1; LABETALOL HYDROCHLORIDE 200 mg/1; LABETALOL HYDROCHLORIDE 300 mg/1	Jul 15, 2026	Sep 2, 2026
NCS HealthCare of KY, LLC dba Vangard Labsrepackager	LABETALOL HYDROCHLORIDE 100 mg/1; LABETALOL HYDROCHLORIDE 200 mg/1	Jul 15, 2026	Sep 2, 2026
Northwind Health Company, LLCrepackager	LABETALOL HYDROCHLORIDE 100 mg/1	Jul 15, 2026	Sep 2, 2026
NuCare Pharmaceuticals , Inc.repackager	LABETALOL HYDROCHLORIDE 200 mg/1	Jul 15, 2026	Sep 2, 2026
Piramal Pharma Limited	LABETALOL HYDROCHLORIDE 100 mg/1	Jul 15, 2026	Sep 2, 2026
Redpharm Drugrepackager	LABETALOL HYDROCHLORIDE 100 mg/1	Jul 15, 2026	Sep 2, 2026
RedPharm Drugrepackager	LABETALOL HYDROCHLORIDE 300 mg/1	Jul 15, 2026	Sep 2, 2026
Remedyrepack Inc.repackager	LABETALOL 100 mg/1; LABETALOL HYDROCHLORIDE 100 mg/1; LABETALOL HYDROCHLORIDE 200 mg/1	Jul 15, 2026	Sep 2, 2026
Unichem Pharmaceuticals (USA), Inc.	LABETALOL HYDROCHLORIDE 100 mg/1; LABETALOL HYDROCHLORIDE 200 mg/1; LABETALOL HYDROCHLORIDE 300 mg/1	Jul 15, 2026	Sep 2, 2026
Zydus Lifesciences Limited	LABETALOL HYDROCHLORIDE 100 mg/1; LABETALOL HYDROCHLORIDE 200 mg/1; LABETALOL HYDROCHLORIDE 300 mg/1	Jul 15, 2026	Sep 2, 2026
Zydus Pharmaceuticals USA Inc.	LABETALOL HYDROCHLORIDE 100 mg/1; LABETALOL HYDROCHLORIDE 200 mg/1; LABETALOL HYDROCHLORIDE 300 mg/1	Jul 15, 2026	Sep 2, 2026

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

Cite this page

DrugDashboards, "Labetalol Hydrochloride — NDC 71247-0130-01," retrieved September 4, 2026, https://drugdashboards.com/drug/71247013001.

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