DrugDashboards

Cetirizine Hydrochloride

Cetirizine Hydrochloride · CETIRIZINE HYDROCHLORIDE 10 mg/1 · Tablet · Oral · Bryant Ranch Prepack

NDC 71335-0300-01 · 30 TABLET in 1 BOTTLE · ANDA · View full market →

The short version

45 companies list this market (plus 10 repackagers, which add no supply) — deep enough that no single failure threatens the supply.

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

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.

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)

0.1%chance of a new FDA shortage posting for cetirizine hydrochloride (oral solid) in the next 90 days

1 Class I/II recall(s) in 12 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.

Regulatory

Application
ANDA077829
TE code
—
Approval date
Aug 26, 2009
Patents / exclusivity
None on file
ⓘ How this was built
Data sources
  • FDA Orange Book data files — patent and exclusivity tables for application ANDA077829, 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 — Torrent Pharma Inc., Oral Solution, 1 mg/mL 120 mL (NDC 1366859607) and 480 mL (NDC 1366859611) (listed as “Cetirizine Hydrochloride Solution”)Jun 9, 2022 → last seen May 14, 2023
  • Planned discontinuation — Torrent Pharma Inc., 5 mg/5 mL oral syrup (NDC 13668-596-07)Apr 24, 2019 → last seen Nov 21, 2020

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 Cetirizine Hydrochloride (Tablet)

55 labelers active in the last 30 days, of which 10 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 SolutionsrepackagerCETIRIZINE HYDROCHLORIDE 10 mg/1Jul 15, 2026Sep 3, 2026
Aphena Pharma Solutions - Tennessee, LLCrepackagerCETIRIZINE HYDROCHLORIDE 10 mg/1Jul 15, 2026Sep 3, 2026
Aurobindo Pharma LimitedCETIRIZINE HYDROCHLORIDE 10 mg/1; CETIRIZINE HYDROCHLORIDE 5 mg/1Jul 15, 2026Sep 3, 2026
Aurohealth LLCCETIRIZINE HYDROCHLORIDE 10 mg/1; CETIRIZINE HYDROCHLORIDE 5 mg/1Jul 15, 2026Sep 3, 2026
Cabinet Health P.B.C.CETIRIZINE HYDROCHLORIDE 10 mg/1Jul 15, 2026Sep 3, 2026
Marksans Pharma LimitedCETIRIZINE HYDROCHLORIDE 10 mg/1; CETIRIZINE HYDROCHLORIDE 5 mg/1Jul 15, 2026Sep 3, 2026
Sportpharm LLCCETIRIZINE HYDROCHLORIDE 10 mg/1Jul 15, 2026Sep 3, 2026
Twin Med, LlcCETIRIZINE HYDROCHLORIDE 10 mg/1Jul 15, 2026Sep 3, 2026
Amazon.com Services LLCCETIRIZINE HYDROCHLORIDE 10 mg/1Jul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals Co. (I) Pvt. Ltd.CETIRIZINE HYDROCHLORIDE 1 kg/kgJul 15, 2026Sep 2, 2026
Better Living Brands, LLCCETIRIZINE HYDROCHLORIDE 10 mg/1Jul 15, 2026Sep 2, 2026
Better Living Brands, LlcCETIRIZINE HYDROCHLORIDE 10 mg/1Jul 15, 2026Sep 2, 2026
Bi-MarCETIRIZINE HYDROCHLORIDE 10 mg/1Jul 15, 2026Sep 2, 2026
BluePoint LaboratoriesCETIRIZINE HYDROCHLORIDE 10 mg/1Jul 15, 2026Sep 2, 2026
Bryant Ranch PrepackrepackagerCETIRIZINE HYDROCHLORIDE 10 mg/1; CETIRIZINE HYDROCHLORIDE 5 mg/1Jul 15, 2026Sep 2, 2026
Chain Drug Consortium, LLCCETIRIZINE HYDROCHLORIDE 10 mg/1Jul 15, 2026Sep 2, 2026
Chain Drug Marketing Association Inc.CETIRIZINE HYDROCHLORIDE 10 mg/1Jul 15, 2026Sep 2, 2026
CVS PharmacyCETIRIZINE HYDROCHLORIDE 10 mg/1Jul 15, 2026Sep 2, 2026
CVS Pharmacy, Inc.CETIRIZINE HYDROCHLORIDE 10 mg/1Jul 15, 2026Sep 2, 2026
Dolgencorp, Inc.CETIRIZINE HYDROCHLORIDE 10 mg/1Jul 15, 2026Sep 2, 2026
Family Dollar Services, IncCETIRIZINE HYDROCHLORIDE 10 mg/1Jul 15, 2026Sep 2, 2026
First Nation Group, LLCCETIRIZINE HYDROCHLORIDE 10 mg/1Jul 15, 2026Sep 2, 2026
Granules USA, Inc.CETIRIZINE HYDROCHLORIDE 10 mg/1Jul 15, 2026Sep 2, 2026
Innovus Pharmaceuticals, Inc.CETIRIZINE HYDROCHLORIDE 10 mg/1Jul 15, 2026Sep 2, 2026
Innovus Pharmaceuticals, Inc.CETIRIZINE HYDROCHLORIDE 10 mg/1Jul 15, 2026Sep 2, 2026
Kroger CompanyCETIRIZINE HYDROCHLORIDE 10 mg/1Jul 15, 2026Sep 2, 2026
Lidl Us, LlcCETIRIZINE HYDROCHLORIDE 10 mg/1Jul 15, 2026Sep 2, 2026
Magno-Humphries, Inc.CETIRIZINE HYDROCHLORIDE 10 mg/1Jul 15, 2026Sep 2, 2026
Marc Glassman, Inc.CETIRIZINE HYDROCHLORIDE 10 mg/1Jul 15, 2026Sep 2, 2026
Marlex Pharmaceuticals, IncCETIRIZINE HYDROCHLORIDE 10 mg/1Jul 15, 2026Sep 2, 2026
NorthStar Rx LLCCETIRIZINE HYDROCHLORIDE 10 mg/1Jul 15, 2026Sep 2, 2026
Northwind Health Company, LLCrepackagerCETIRIZINE HYDROCHLORIDE 10 mg/1Jul 15, 2026Sep 2, 2026
NuCare Pharmaceuticals, Inc.repackagerCETIRIZINE HYDROCHLORIDE 10 mg/1Jul 15, 2026Sep 2, 2026
NuCare Pharmaceuticals,Inc.repackagerCETIRIZINE HYDROCHLORIDE 10 mg/1Jul 15, 2026Sep 2, 2026
Ohm Laboratories IncCETIRIZINE HYDROCHLORIDE 10 mg/1Jul 15, 2026Sep 2, 2026
Ohm Laboratories Inc.CETIRIZINE HYDROCHLORIDE 10 mg/1Jul 15, 2026Sep 2, 2026
Pls AnalyticalCETIRIZINE HYDROCHLORIDE 10 mg/1Jul 15, 2026Sep 2, 2026
Preferred Pharmaceuticals Inc.repackagerCETIRIZINE HYDROCHLORIDE 10 mg/1Jul 15, 2026Sep 2, 2026
Proficient Rx LPrepackagerCETIRIZINE HYDROCHLORIDE 5 mg/1; CETIRIZINE HYDROCHLORIDE 10 mg/1Jul 15, 2026Sep 2, 2026
Publix Super Markets IncCETIRIZINE HYDROCHLORIDE 10 mg/1Jul 15, 2026Sep 2, 2026
Retail Business Services,llc.CETIRIZINE HYDROCHLORIDE 10 mg/1Jul 15, 2026Sep 2, 2026
Rising Pharma Holdings, Inc.CETIRIZINE HYDROCHLORIDE 10 mg/1; CETIRIZINE HYDROCHLORIDE 5 mg/1Jul 15, 2026Sep 2, 2026
SafewayCETIRIZINE HYDROCHLORIDE 10 mg/1Jul 15, 2026Sep 2, 2026
Sandoz IncCETIRIZINE HYDROCHLORIDE 10 mg/1Jul 15, 2026Sep 2, 2026
SDA Laboratories, Inc.CETIRIZINE HYDROCHLORIDE 10 mg/1Jul 15, 2026Sep 2, 2026
St. Mary's Medical Park PharmacyrepackagerCETIRIZINE HYDROCHLORIDE 10 mg/1Jul 15, 2026Sep 2, 2026
Strive Pharmaceuticals IncCETIRIZINE HYDROCHLORIDE 10 mg/1Jul 15, 2026Sep 2, 2026
Time Cap Laboratories, Inc.CETIRIZINE HYDROCHLORIDE 10 mg/1; CETIRIZINE HYDROCHLORIDE 5 mg/1Jul 15, 2026Sep 2, 2026
Umasuto, LLCCETIRIZINE HYDROCHLORIDE 10 mg/1Jul 15, 2026Sep 2, 2026
Valu Merchandisers CompanyCETIRIZINE HYDROCHLORIDE 10 mg/1Jul 15, 2026Sep 2, 2026
Walgreen Co.CETIRIZINE HYDROCHLORIDE 10 mg/1Jul 15, 2026Sep 2, 2026
WalgreensCETIRIZINE HYDROCHLORIDE 10 mg/1Jul 15, 2026Sep 2, 2026
Yyba CorpCETIRIZINE HYDROCHLORIDE 10 mg/1Jul 15, 2026Sep 2, 2026
Opmx LlcCETIRIZINE HYDROCHLORIDE 10 mg/1Jul 15, 2026Aug 28, 2026
PD-Rx Pharmaceuticals, Inc.repackagerCETIRIZINE HYDROCHLORIDE 10 mg/1Jul 15, 2026Aug 28, 2026

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

Cite this page

DrugDashboards, "Cetirizine Hydrochloride — NDC 71335-0300-01," retrieved September 4, 2026, https://drugdashboards.com/drug/71335030001.

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