Diclofenac Sodium Topical Solution
Diclofenac Sodium Topical Solution · DICLOFENAC SODIUM 20 mg/g · Solution · Topical · Direct_Rx
NDC 72189-0546-04 · 112 g in 1 BOTTLE · ANDA · View full market →
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
- 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)
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)
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
- FDA NDC Directory labeler counts, CMS NADAC price trend, openFDA shortages and enforcement, FDA inspection classifications, Wayback archive of FDA's shortage list (labels)
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
- Direct Rxnot a makerUnited Statesrelabel
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
- 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)
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
- ANDA213040
- TE code
- AB
- Approval date
- Feb 3, 2023
- Patents / exclusivity
- None on file
ⓘ How this was built
- FDA Orange Book data files — patent and exclusivity tables for application ANDA213040, edition retrieved 2026-08-24
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
- 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
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.
- Planned discontinuation — Amneal Pharmaceuticals, Diclofenac Sodium, Gel, 10 mg/1 g (NDC 65162-833-66) (listed as “Diclofenac Sodium Gel”)Aug 1, 2023 → last seen Jul 18, 2024
- Planned discontinuation — Mylan Pharmaceuticals Inc., 100 mg (NDC 0378-0355-01) (listed as “Diclofenac Sodium Extended Release Tablets”)Apr 4, 2018 → last seen May 14, 2023
- Planned discontinuation — Teligent Pharma, Inc., 1.5% 60mL bottle (NDC 52565-002-59)Feb 18, 2021 → last seen Nov 30, 2021
- Planned discontinuation — Teligent Pharma, Inc., 1.5% 150mL bottle (NDC 51565-002-05)Feb 18, 2021 → last seen Nov 30, 2021
- Planned discontinuation — Apotex Corp., 1.5% topical solution (NDC 60505-0399-5)May 6, 2020 → last seen Aug 2, 2021
- Planned discontinuation — Endo Pharmaceuticals, Inc., 1% topical gel (NDC 49884-935-47) (listed as “Diclofenac Sodium Topical Gel”)Feb 13, 2020 → last seen Aug 2, 2021
- Planned discontinuation — Apotex Corp., 2% topical solution (NDC 60505-0399-5)May 6, 2020 → last seen Jan 17, 2021
Recalls (this NDC)
ⓘ How this was built
- FDA drug enforcement reports via openFDA
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 Diclofenac Sodium Topical Solution (Solution)
1 labeler active in the last 30 days, of which 1 is a repackager; 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
- 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)
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 |
|---|---|---|---|
| Direct_Rxrepackager | DICLOFENAC SODIUM 20 mg/g | Jul 15, 2026 | Sep 3, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 15, 2026.
Cite this page
DrugDashboards, "Diclofenac Sodium Topical Solution — NDC 72189-0546-04," retrieved September 4, 2026, https://drugdashboards.com/drug/72189054604.
Free to cite with attribution — see how the data is put together.