DrugDashboards

Diphenoxylate Hydrochloride and Atropine Sulfate

Diphenoxylate Hydrochloride and Atropine Sulfate · DIPHENOXYLATE HYDROCHLORIDE 2.5 mg/1; ATROPINE SULFATE .025 mg/1 · Tablet · Oral · Winder Laboratories LLC

NDC 75826-0107-00 · 1000 TABLET in 1 BOTTLE, PLASTIC · ANDA · View full market →

The short version

20 companies supply this market — deep enough that no single failure threatens the supply. The price is down 25% over the past year, to $0.1386 per unit. One of its named manufacturing plants, Winder Laboratories, Llc, failed FDA inspectionwithin the last two years — the agency’s most serious outcome. 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.

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 (pharmacy acquisition, weekly)
  • CMS Part B ASP quarterly payment limits
  • CMS Maximum Fair Prices (IRA negotiated, NDC-level)
  • Medicare Part D Spending by Drug (data.cms.gov, name-matched)
  • VA FSS / Big4 federal contract prices (va.gov, twice monthly)
  • ACA Federal Upper Limits + weighted AMP (data.medicaid.gov, monthly)
  • California SB-17 WAC filings (list price, per package)
Method

Each rung is the newest figure for this NDC from one federal price system, shown with its own unit. Part D is matched by drug name because CMS publishes no NDCs there; it is gross spending, before confidential rebates.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

  • Pharmacies pay (NADAC)$0.1386per EAinvoice-surveyed acquisition cost · Aug 19, 2026
  • Medicaid generic ceiling (FUL)$0.1386per TABweighted avg manufacturer price $0.0729 · Aug 1, 2026100% of what pharmacies pay — higher than 10% of drugs with this benchmark

Medicare Part D

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 00025-0061-31) — 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
$3.27per unit
middle half $3.27$3.27 · 10 plans · Apr 1, 2026
Est. net of rebates
≈ $3.27
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
0%of plans cover it
tier 4 · prior auth 100% · step therapy 0% · qty limit 0%

*No drug-level rebate is public — the estimate applies MedPAC's program-wide brand rebate range to this drug's gross price. Tracked here for 10 quarters since 2024.

NADAC price per unit

$0$0.1$0.2$0.3Oct 2022Sep 2026$0.1386
48 price points · per EA · dashed = manufacturer avg (WAMP)Source: CMS NADAC

Estimated fill cost

#30 count
$4.16
#90 count
$12.47

Estimates: latest NADAC unit price × quantity. Pharmacy acquisition cost only — excludes dispensing fees, markup, and insurance terms.

Medicaid spend (2025)

$22,787
2,068 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

8Low risk

Some pressure is visible, but not much — here’s everything the score found to count.

  • price down 25% year over year+8

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 3, 2026

90-day shortage risk (model v2)

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

OAI inspection at a producing facility (24 months) · sole-source market

For scale: the typical drug’s chance is about 0.1% — this one is in ordinary territory.

Backtested statistical model over the whole market, not this package alone. Model details →

Where it's made

Establishments this product's FDA label declares, located via FDA registration data. How we built this →

Regulatory

Application
ANDA211362
TE code
AA
Approval date
Jan 27, 2021
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of Diphenoxylate Hydrochloride and Atropine Sulfate (Tablet)

LabelerStrengthFirst seenLast seen
A-S Medication SolutionsDIPHENOXYLATE HYDROCHLORIDE 2.5 mg/1; ATROPINE SULFATE .025 mg/1Aug 26, 2026Sep 3, 2026
Aphena Pharma Solutions - Tennessee, LLCDIPHENOXYLATE HYDROCHLORIDE 2.5 mg/1; ATROPINE SULFATE .025 mg/1Aug 26, 2026Sep 3, 2026
Bryant Ranch PrepackDIPHENOXYLATE HYDROCHLORIDE 2.5 mg/1; ATROPINE SULFATE .025 mg/1Aug 26, 2026Sep 3, 2026
American Health PackagingDIPHENOXYLATE HYDROCHLORIDE 2.5 mg/1; ATROPINE SULFATE .025 mg/1Aug 26, 2026Sep 2, 2026
ANI Pharmaceuticals, Inc.DIPHENOXYLATE HYDROCHLORIDE 2.5 mg/1; ATROPINE SULFATE .025 mg/1Aug 26, 2026Sep 2, 2026
Chartwell RX, LLCDIPHENOXYLATE HYDROCHLORIDE 2.5 mg/1; ATROPINE SULFATE .025 mg/1Aug 26, 2026Sep 2, 2026
Direct RxDIPHENOXYLATE HYDROCHLORIDE 2.5 mg/1; ATROPINE SULFATE .025 mg/1Aug 26, 2026Sep 2, 2026
Leading Pharma, LLCDIPHENOXYLATE HYDROCHLORIDE 2.5 mg/1; ATROPINE SULFATE .025 mg/1Aug 26, 2026Sep 2, 2026
Mylan Pharmaceuticals Inc.DIPHENOXYLATE HYDROCHLORIDE 2.5 mg/1; ATROPINE SULFATE .025 mg/1Aug 26, 2026Sep 2, 2026
NuCare Pharmaceuticals,Inc.DIPHENOXYLATE HYDROCHLORIDE 2.5 mg/1; ATROPINE SULFATE .025 mg/1Aug 26, 2026Sep 2, 2026
PD-Rx Pharmaceuticals, Inc.DIPHENOXYLATE HYDROCHLORIDE 2.5 mg/1; ATROPINE SULFATE .025 mg/1Aug 26, 2026Sep 2, 2026
Pfizer Laboratories Div Pfizer IncDIPHENOXYLATE HYDROCHLORIDE 2.5 mg/1; ATROPINE SULFATE .025 mg/1Aug 26, 2026Sep 2, 2026
Preferred Pharmaceuticals Inc.DIPHENOXYLATE HYDROCHLORIDE 2.5 mg/1; ATROPINE SULFATE .025 mg/1Aug 26, 2026Sep 2, 2026
Redpharm DrugDIPHENOXYLATE HYDROCHLORIDE 2.5 mg/1; ATROPINE SULFATE .025 mg/1Aug 26, 2026Sep 2, 2026
Redpharm Drug Inc.DIPHENOXYLATE HYDROCHLORIDE 2.5 mg/1; ATROPINE SULFATE .025 mg/1Aug 26, 2026Sep 2, 2026
Remedyrepack Inc.DIPHENOXYLATE HYDROCHLORIDE 2.5 mg/1; ATROPINE SULFATE .025 mg/1Aug 26, 2026Sep 2, 2026
SpecGx LLCDIPHENOXYLATE HYDROCHLORIDE 2.5 mg/1; ATROPINE SULFATE .025 mg/1Aug 26, 2026Sep 2, 2026
Unichem Pharmaceuticals (USA), Inc.DIPHENOXYLATE HYDROCHLORIDE 2.5 mg/1; ATROPINE SULFATE .025 mg/1Aug 26, 2026Sep 2, 2026
Winder Laboratories LLCDIPHENOXYLATE HYDROCHLORIDE 2.5 mg/1; ATROPINE SULFATE .025 mg/1Aug 26, 2026Sep 2, 2026
Proficient Rx LPDIPHENOXYLATE HYDROCHLORIDE 2.5 mg/1; ATROPINE SULFATE .025 mg/1Aug 26, 2026Aug 31, 2026
Aphena Pharma Solutions - Tennessee, LLCDIPHENOXYLATE HYDROCHLORIDE .025 mg/1; ATROPINE SULFATE 2.5 mg/1Jul 22, 2026Aug 22, 2026
A-S Medication SolutionsDIPHENOXYLATE HYDROCHLORIDE .025 mg/1; ATROPINE SULFATE 2.5 mg/1Jul 22, 2026Aug 21, 2026
Bryant Ranch PrepackDIPHENOXYLATE HYDROCHLORIDE .025 mg/1; ATROPINE SULFATE 2.5 mg/1Jul 22, 2026Aug 21, 2026
Proficient Rx LPDIPHENOXYLATE HYDROCHLORIDE .025 mg/1; ATROPINE SULFATE 2.5 mg/1Jul 22, 2026Aug 21, 2026
American Health PackagingDIPHENOXYLATE HYDROCHLORIDE .025 mg/1; ATROPINE SULFATE 2.5 mg/1Jul 22, 2026Aug 19, 2026
ANI Pharmaceuticals, Inc.DIPHENOXYLATE HYDROCHLORIDE .025 mg/1; ATROPINE SULFATE 2.5 mg/1Jul 22, 2026Aug 19, 2026
Chartwell RX, LLCDIPHENOXYLATE HYDROCHLORIDE .025 mg/1; ATROPINE SULFATE 2.5 mg/1Jul 22, 2026Aug 19, 2026
Direct RxDIPHENOXYLATE HYDROCHLORIDE .025 mg/1; ATROPINE SULFATE 2.5 mg/1Jul 22, 2026Aug 19, 2026
Leading Pharma, LLCDIPHENOXYLATE HYDROCHLORIDE .025 mg/1; ATROPINE SULFATE 2.5 mg/1Jul 22, 2026Aug 19, 2026
Mylan Pharmaceuticals Inc.DIPHENOXYLATE HYDROCHLORIDE .025 mg/1; ATROPINE SULFATE 2.5 mg/1Jul 22, 2026Aug 19, 2026
NuCare Pharmaceuticals,Inc.DIPHENOXYLATE HYDROCHLORIDE .025 mg/1; ATROPINE SULFATE 2.5 mg/1Jul 22, 2026Aug 19, 2026
PD-Rx Pharmaceuticals, Inc.DIPHENOXYLATE HYDROCHLORIDE .025 mg/1; ATROPINE SULFATE 2.5 mg/1Jul 22, 2026Aug 19, 2026
Pfizer Laboratories Div Pfizer IncDIPHENOXYLATE HYDROCHLORIDE .025 mg/1; ATROPINE SULFATE 2.5 mg/1Jul 22, 2026Aug 19, 2026
Preferred Pharmaceuticals Inc.DIPHENOXYLATE HYDROCHLORIDE .025 mg/1; ATROPINE SULFATE 2.5 mg/1Jul 22, 2026Aug 19, 2026
Redpharm DrugDIPHENOXYLATE HYDROCHLORIDE .025 mg/1; ATROPINE SULFATE 2.5 mg/1Jul 22, 2026Aug 19, 2026
Redpharm Drug Inc.DIPHENOXYLATE HYDROCHLORIDE .025 mg/1; ATROPINE SULFATE 2.5 mg/1Jul 22, 2026Aug 19, 2026
Remedyrepack Inc.DIPHENOXYLATE HYDROCHLORIDE .025 mg/1; ATROPINE SULFATE 2.5 mg/1Jul 22, 2026Aug 19, 2026
SpecGx LLCDIPHENOXYLATE HYDROCHLORIDE .025 mg/1; ATROPINE SULFATE 2.5 mg/1Jul 22, 2026Aug 19, 2026
Unichem Pharmaceuticals (USA), Inc.DIPHENOXYLATE HYDROCHLORIDE .025 mg/1; ATROPINE SULFATE 2.5 mg/1Jul 22, 2026Aug 19, 2026
Winder Laboratories LLCDIPHENOXYLATE HYDROCHLORIDE .025 mg/1; ATROPINE SULFATE 2.5 mg/1Jul 22, 2026Aug 19, 2026

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

Cite this page

DrugDashboards, "Diphenoxylate Hydrochloride and Atropine Sulfate — NDC 75826-0107-00," retrieved September 3, 2026, https://drugdashboards.com/drug/75826010700.

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