DrugDashboards

Promethazine Hydrochloride

Promethazine Hydrochloride · PROMETHAZINE HYDROCHLORIDE 25 mg/1 · Tablet · Oral · Direct Rx

NDC 72189-0176-10 · 10 TABLET in 1 BOTTLE · ANDA · View full market →

The short version

9 companies list this market (plus 17 repackagers, which add no supply) — 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.

ⓘ 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 68382-0041-01) — 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ⓘ
$0.1082per unit
middle half $0.0672–$0.2318 · 5,474 plans · Apr 1, 2026
Est. net of rebatesⓘ
≈ $0.1082
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
100%of plans cover it
tier 3 · prior auth 50% · 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.

No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.

Supply fragility

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

90-day shortage risk (model v2)

0.2%chance of a new FDA shortage posting for promethazine hydrochloride (oral solid) in the next 90 days

OAI inspection at a producing facility (24 months)

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.

Establishments on the label

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
ANDA040596
TE code
AB
Approval date
Nov 18, 2005
Patents / exclusivity
None on file
ⓘ How this was built
Data sources
  • FDA Orange Book data files — patent and exclusivity tables for application ANDA040596, 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+)
  • In shortage now — Hikma Pharmaceuticals USA, Inc., Phenergan, Injection, 50 mg/1 mL (NDC 0641-6085-25) (listed as “Promethazine Hydrochloride Injection”)Nov 21, 2023 → last seen Jul 20, 2026
  • In shortage now — Hikma Pharmaceuticals USA, Inc., Phenergan, Injection, 50 mg/1 mL (NDC 0641-6083-25) (listed as “Promethazine Hydrochloride Injection”)Nov 21, 2023 → last seen Jul 20, 2026
  • In shortage now — Hikma Pharmaceuticals USA, Inc., Promethazine Hydrochloride, Injection, 50 mg/1 mL (NDC 0641-0929-25) (listed as “Promethazine Hydrochloride Injection”)Nov 21, 2023 → last seen Jul 20, 2026
  • In shortage now — Hikma Pharmaceuticals USA, Inc., Promethazine Hydrochloride, Injection, 25 mg/1 mL (NDC 0641-1495-35) (listed as “Promethazine Hydrochloride Injection”)Nov 21, 2023 → last seen Jul 20, 2026
  • In shortage now — Hikma Pharmaceuticals USA, Inc., Promethazine Hydrochloride, Injection, 50 mg/1 mL (NDC 0641-1496-35) (listed as “Promethazine Hydrochloride Injection”)Nov 21, 2023 → last seen Jul 20, 2026
  • In shortage now — Hikma Pharmaceuticals USA, Inc., Phenergan, Injection, 25 mg/1 mL (NDC 0641-6084-25) (listed as “Promethazine Hydrochloride Injection”)Nov 21, 2023 → last seen Jul 20, 2026
  • In shortage now — Hikma Pharmaceuticals USA, Inc., Phenergan, Injection, 25 mg/1 mL (NDC 0641-6082-25) (listed as “Promethazine Hydrochloride Injection”)Nov 21, 2023 → last seen Jul 20, 2026
  • In shortage now — XGen Pharmaceuticals DJB, Inc., Promethazine Hydrochloride, Injection, 25 mg/1 mL (NDC 39822-5525-3) (listed as “Promethazine Hydrochloride Injection”)Nov 21, 2023 → last seen Jul 20, 2026

Showing 8 of 30 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 Promethazine Hydrochloride (Tablet)

26 labelers active in the last 30 days, of which 17 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 SolutionsrepackagerPROMETHAZINE HYDROCHLORIDE 25 mg/1; PROMETHAZINE HYDROCHLORIDE 12.5 mg/1Jul 15, 2026Sep 3, 2026
Actavis Pharma, Inc.PROMETHAZINE HYDROCHLORIDE 50 mg/1; PROMETHAZINE HYDROCHLORIDE 25 mg/1Jul 15, 2026Sep 3, 2026
Bryant Ranch PrepackrepackagerPROMETHAZINE HYDROCHLORIDE 12.5 mg/1; PROMETHAZINE HYDROCHLORIDE 25 mg/1Jul 15, 2026Sep 3, 2026
NuCare Pharmaceuticals,Inc.repackagerPROMETHAZINE HYDROCHLORIDE 25 mg/1Jul 15, 2026Sep 3, 2026
PD-Rx Pharmaceuticals, Inc.repackagerPROMETHAZINE HYDROCHLORIDE 25 mg/1; PROMETHAZINE HYDROCHLORIDE 12.5 mg/1; PROMETHAZINE HYDROCHLORIDE 50 mg/1Jul 15, 2026Sep 3, 2026
Proficient Rx LPrepackagerPROMETHAZINE HYDROCHLORIDE 25 mg/1Jul 15, 2026Sep 3, 2026
Advanced Rx Pharmacy of Tennessee, LLCrepackagerPROMETHAZINE HYDROCHLORIDE 25 mg/1Jul 15, 2026Sep 2, 2026
American Health PackagingrepackagerPROMETHAZINE HYDROCHLORIDE 12.5 mg/1; PROMETHAZINE HYDROCHLORIDE 25 mg/1Jul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals LLCPROMETHAZINE HYDROCHLORIDE 12.5 mg/1; PROMETHAZINE HYDROCHLORIDE 25 mg/1; PROMETHAZINE HYDROCHLORIDE 50 mg/1Jul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals of New York LLCPROMETHAZINE HYDROCHLORIDE 12.5 mg/1; PROMETHAZINE HYDROCHLORIDE 25 mg/1; PROMETHAZINE HYDROCHLORIDE 50 mg/1Jul 15, 2026Sep 2, 2026
Asclemed Usa Inc.repackagerPROMETHAZINE HYDROCHLORIDE 12.5 mg/1; PROMETHAZINE HYDROCHLORIDE 25 mg/1; PROMETHAZINE HYDROCHLORIDE 50 mg/1Jul 15, 2026Sep 2, 2026
Asclemed USA, Inc.repackagerPROMETHAZINE HYDROCHLORIDE 12.5 mg/1; PROMETHAZINE HYDROCHLORIDE 25 mg/1; PROMETHAZINE HYDROCHLORIDE 50 mg/1Jul 15, 2026Sep 2, 2026
BluePoint LaboratoriesPROMETHAZINE HYDROCHLORIDE 12.5 mg/1; PROMETHAZINE HYDROCHLORIDE 25 mg/1; PROMETHAZINE HYDROCHLORIDE 50 mg/1Jul 15, 2026Sep 2, 2026
Cardinal Health 107, LLCrepackagerPROMETHAZINE HYDROCHLORIDE 25 mg/1Jul 15, 2026Sep 2, 2026
Coupler LLCrepackagerPROMETHAZINE HYDROCHLORIDE 25 mg/1; PROMETHAZINE HYDROCHLORIDE 50 mg/1Jul 15, 2026Sep 2, 2026
Direct RxrepackagerPROMETHAZINE HYDROCHLORIDE 25 mg/1Jul 15, 2026Sep 2, 2026
KVK-Tech, Inc.PROMETHAZINE HYDROCHLORIDE 12.5 mg/1; PROMETHAZINE HYDROCHLORIDE 25 mg/1; PROMETHAZINE HYDROCHLORIDE 50 mg/1Jul 15, 2026Sep 2, 2026
Major PharmaceuticalsPROMETHAZINE HYDROCHLORIDE 25 mg/1Jul 15, 2026Sep 2, 2026
NCS HealthCare of KY, LLC dba Vangard LabsrepackagerPROMETHAZINE HYDROCHLORIDE 25 mg/1Jul 15, 2026Sep 2, 2026
Preferred Pharmaceuticals Inc.repackagerPROMETHAZINE HYDROCHLORIDE 25 mg/1Jul 15, 2026Sep 2, 2026
Remedyrepack Inc.repackagerPROMETHAZINE HYDROCHLORIDE 12.5 mg/1; PROMETHAZINE HYDROCHLORIDE 25 mg/1Jul 15, 2026Sep 2, 2026
Sportpharm LLCPROMETHAZINE HYDROCHLORIDE 12.5 mg/1; PROMETHAZINE HYDROCHLORIDE 25 mg/1; PROMETHAZINE HYDROCHLORIDE 50 mg/1Jul 15, 2026Sep 2, 2026
Unit Dose Solutions, Inc.repackagerPROMETHAZINE HYDROCHLORIDE 25 mg/1Jul 15, 2026Sep 2, 2026
Zydus Lifesciences LimitedPROMETHAZINE HYDROCHLORIDE 12.5 mg/1; PROMETHAZINE HYDROCHLORIDE 25 mg/1; PROMETHAZINE HYDROCHLORIDE 50 mg/1Jul 15, 2026Sep 2, 2026
Zydus Pharmaceuticals USA Inc.PROMETHAZINE HYDROCHLORIDE 12.5 mg/1; PROMETHAZINE HYDROCHLORIDE 25 mg/1; PROMETHAZINE HYDROCHLORIDE 50 mg/1Jul 15, 2026Sep 2, 2026
Northwind Health Company, LLCrepackagerPROMETHAZINE HYDROCHLORIDE 25 mg/1Jul 15, 2026Aug 31, 2026

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

Cite this page

DrugDashboards, "Promethazine Hydrochloride — NDC 72189-0176-10," retrieved September 4, 2026, https://drugdashboards.com/drug/72189017610.

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