DrugDashboards

Diclofenac Sodium

Diclofenac Sodium · DICLOFENAC SODIUM 10 mg/g · Gel · Topical · Innovus Pharmaceuticals, Inc.

NDC 57483-0185-11 · 1 TUBE in 1 CARTON / 150 g in 1 TUBE · ANDA · View full market →

The short version

58 companies list this market (plus 13 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 diclofenac sodium (other) 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
ANDA204306
TE code
—
Approval date
May 6, 2019
Patents / exclusivity
None on file
ⓘ How this was built
Data sources
  • FDA Orange Book data files — patent and exclusivity tables for application ANDA204306, 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 — 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) (listed as “Diclofenac Sodium Topical Solution”)Feb 18, 2021 → last seen Nov 30, 2021
  • Planned discontinuation — Teligent Pharma, Inc., 1.5% 150mL bottle (NDC 51565-002-05) (listed as “Diclofenac Sodium Topical Solution”)Feb 18, 2021 → last seen Nov 30, 2021
  • Planned discontinuation — Apotex Corp., 1.5% topical solution (NDC 60505-0399-5) (listed as “Diclofenac Sodium Topical Solution”)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) (listed as “Diclofenac Sodium Topical Solution”)May 6, 2020 → last seen Jan 17, 2021

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 Diclofenac Sodium (Gel)

71 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.

LabelerStrengthsFirst seenLast seen
A-S Medication SolutionsrepackagerDICLOFENAC SODIUM 10 mg/gJul 15, 2026Sep 3, 2026
Asclemed USA, Inc.repackagerDICLOFENAC SODIUM 30 mg/gJul 15, 2026Sep 3, 2026
Aurohealth LLCDICLOFENAC SODIUM 10 mg/gJul 15, 2026Sep 3, 2026
Costco WholesaleDICLOFENAC SODIUM 10 mg/gJul 15, 2026Sep 3, 2026
Costco Wholesale CompanyDICLOFENAC SODIUM 10 mg/gJul 15, 2026Sep 3, 2026
CVS PharmacyDICLOFENAC SODIUM 10 mg/gJul 15, 2026Sep 3, 2026
Cvs Pharmacy, IncDICLOFENAC SODIUM 10 mg/gJul 15, 2026Sep 3, 2026
Cvs Woonsocket Prescription Center, IncorporatedDICLOFENAC SODIUM 10 mg/gJul 15, 2026Sep 3, 2026
Hawaii Repack, IncrepackagerDICLOFENAC SODIUM 30 mg/gJul 16, 2026Sep 3, 2026
L. Perrigo CompanyDICLOFENAC SODIUM 10 mg/gJul 15, 2026Sep 3, 2026
NuCare Pharmaceuticals,Inc.repackagerDICLOFENAC SODIUM 30 mg/g; DICLOFENAC SODIUM 10 mg/gJul 15, 2026Sep 3, 2026
Preferred Pharmaceuticals Inc.repackagerDICLOFENAC SODIUM 10 mg/g; DICLOFENAC SODIUM 30 mg/gJul 15, 2026Sep 3, 2026
Proficient Rx LPrepackagerDICLOFENAC SODIUM 10 mg/g; DICLOFENAC SODIUM 30 mg/gJul 15, 2026Sep 3, 2026
Target CorporationDICLOFENAC SODIUM 10 mg/gJul 15, 2026Sep 3, 2026
Topco Associates LLCDICLOFENAC SODIUM 10 mg/gJul 15, 2026Sep 3, 2026
Walgreen CompanyDICLOFENAC SODIUM 10 mg/gJul 15, 2026Sep 3, 2026
Yyba CorpDICLOFENAC SODIUM 10 mg/g; DICLOFENAC SODIUM 1 mg/100gJul 15, 2026Sep 3, 2026
Actavis Pharma, Inc.DICLOFENAC SODIUM 30 mg/gJul 15, 2026Sep 2, 2026
Advanced Rx Pharmacy of Tennessee, LLCrepackagerDICLOFENAC SODIUM 10 mg/g; DICLOFENAC SODIUM 30 mg/gJul 15, 2026Sep 2, 2026
American Sales CompanyDICLOFENAC SODIUM 10 mg/gJul 15, 2026Sep 2, 2026
AmerisourceBergen (Good Neighbor Pharmacy) 46122DICLOFENAC SODIUM 10 mg/gJul 15, 2026Sep 2, 2026
Aurobindo Pharma LimitedDICLOFENAC SODIUM 10 mg/gJul 15, 2026Sep 2, 2026
Bayer HealthCare LLCDICLOFENAC SODIUM 1 mg/gJul 15, 2026Sep 2, 2026
Best Choice (Valu Merchandisers Company)DICLOFENAC SODIUM 10 mg/gJul 15, 2026Sep 2, 2026
Bora Pharmaceutical Services Inc.DICLOFENAC SODIUM 10 mg/gJul 15, 2026Sep 2, 2026
Cardinal Health 110, Llc. Dba Leader 70000DICLOFENAC SODIUM 10 mg/gJul 15, 2026Sep 2, 2026
Care One (Retail Business Services, LLC.)DICLOFENAC SODIUM 10 mg/gJul 15, 2026Sep 2, 2026
Chain Drug Consortium, LLCDICLOFENAC SODIUM 10 mg/gJul 15, 2026Sep 2, 2026
Chattem, Inc.DICLOFENAC SODIUM .01 g/gJul 15, 2026Sep 2, 2026
Cipla USA Inc.DICLOFENAC SODIUM 10 mg/gJul 15, 2026Sep 2, 2026
Direct_RxrepackagerDICLOFENAC SODIUM 30 mg/gJul 15, 2026Sep 2, 2026
EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)DICLOFENAC SODIUM 10 mg/gJul 15, 2026Sep 2, 2026
Exelan Pharmaceuticals Inc.DICLOFENAC SODIUM 10 mg/gJul 15, 2026Sep 2, 2026
Family Dollar (FAMILY WELLNESS)DICLOFENAC SODIUM 10 mg/gJul 15, 2026Sep 2, 2026
Geri-Care Pharmaceutical CorpDICLOFENAC SODIUM 10 mg/gJul 15, 2026Sep 2, 2026
Glenmark Pharmaceuticals Inc., UsaDICLOFENAC SODIUM 30 mg/gJul 15, 2026Sep 2, 2026
Haleon US Holdings LLCDICLOFENAC SODIUM 10 mg/gJul 15, 2026Sep 2, 2026
Harris TeeterDICLOFENAC SODIUM 10 mg/gJul 15, 2026Sep 2, 2026
Hisamitsu America, Inc.DICLOFENAC SODIUM 10 mg/gJul 15, 2026Sep 2, 2026
HyVee IncDICLOFENAC SODIUM 10 mg/gJul 15, 2026Sep 2, 2026
Innovus Pharmaceuticals, Inc.DICLOFENAC SODIUM 10 mg/gJul 15, 2026Sep 2, 2026
Kenvue Brands LLCDICLOFENAC SODIUM 9.3 mg/gJul 15, 2026Sep 2, 2026
Kroger CompanyDICLOFENAC SODIUM 10 mg/gJul 15, 2026Sep 2, 2026
Little Pharma, Inc.DICLOFENAC SODIUM 1 g/100gJul 15, 2026Sep 2, 2026
Meijer Distribution IncDICLOFENAC SODIUM 10 mg/gJul 15, 2026Sep 2, 2026
Meijer, Inc.DICLOFENAC SODIUM 10 mg/gJul 15, 2026Sep 2, 2026
P & L Development, LLCDICLOFENAC SODIUM 10 mg/gJul 15, 2026Sep 2, 2026
Padagis Israel Pharmaceuticals LtdDICLOFENAC SODIUM 10 mg/g; DICLOFENAC SODIUM 30 mg/gJul 15, 2026Sep 2, 2026
Pioneer Life Sciences, LLCDICLOFENAC SODIUM .01 g/gJul 15, 2026Sep 2, 2026
Quality Care Products, LLCrepackagerDICLOFENAC SODIUM 10 mg/gJul 15, 2026Sep 2, 2026
QUALITY CHOICE (Chain Drug Marketing Association)DICLOFENAC SODIUM 10 mg/gJul 15, 2026Sep 2, 2026
Redpharm DrugrepackagerDICLOFENAC SODIUM 10 mg/gJul 15, 2026Sep 2, 2026
Rite Aid CorporationDICLOFENAC SODIUM 10 mg/gJul 15, 2026Sep 2, 2026
Rugby LaboratoriesDICLOFENAC SODIUM 10 mg/gJul 15, 2026Sep 2, 2026
Safeway, Inc.DICLOFENAC SODIUM 10 mg/gJul 15, 2026Sep 2, 2026
Sam's West IncDICLOFENAC SODIUM 10 mg/gJul 15, 2026Sep 2, 2026
Strategic Sourcing Services LLCDICLOFENAC SODIUM 10 mg/gJul 15, 2026Sep 2, 2026
Sun Pharmaceutical Industries, Inc.DICLOFENAC SODIUM 30 mg/gJul 15, 2026Sep 2, 2026
United Natural Foods, Inc. dba UNFIDICLOFENAC SODIUM 10 mg/gJul 15, 2026Sep 2, 2026
Wal-Mart Stores IncDICLOFENAC SODIUM 10 mg/gJul 15, 2026Sep 2, 2026
WalgreensDICLOFENAC SODIUM 10 mg/gJul 15, 2026Sep 2, 2026
Walmart Inc.DICLOFENAC SODIUM 10 mg/gJul 15, 2026Sep 2, 2026
Amazon.com Services LLCDICLOFENAC SODIUM 10 mg/gJul 15, 2026Aug 31, 2026
Dolgencorp IncDICLOFENAC SODIUM 10 mg/gJul 15, 2026Aug 31, 2026
H E BDICLOFENAC SODIUM 10 mg/gJul 15, 2026Aug 31, 2026
Publix Super Markets IncDICLOFENAC SODIUM 10 mg/gJul 15, 2026Aug 31, 2026
Remedyrepack Inc.repackagerDICLOFENAC SODIUM 30 mg/gJul 15, 2026Aug 31, 2026
Sportpharm LLCDICLOFENAC SODIUM 10 mg/gJul 15, 2026Aug 31, 2026
Bryant Ranch PrepackrepackagerDICLOFENAC SODIUM 30 mg/gJul 15, 2026Aug 28, 2026
NuCare Pharmaceuticals, Inc.repackagerDICLOFENAC SODIUM 10 mg/gJul 15, 2026Aug 28, 2026
Amneal Pharmaceuticals of New York LLCDICLOFENAC SODIUM 30 mg/gJul 15, 2026Aug 19, 2026

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

Cite this page

DrugDashboards, "Diclofenac Sodium — NDC 57483-0185-11," retrieved September 4, 2026, https://drugdashboards.com/drug/57483018511.

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