DrugDashboards

Diphenoxylate Hydrochloride and Atropine Sulfate

diphenoxylate hydrochloride and atropine sulfate · DIPHENOXYLATE HYDROCHLORIDE 2.5 mg/1; ATROPINE SULFATE .025 mg/1 · Tablet · Oral · Proficient Rx LP

NDC 71205-0909-00 · 100 TABLET in 1 BOTTLE · ANDA · View full market →

The short version

20 companies supply this market — 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.

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

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

Supply fragility

Not scored — fragility is computed for NADAC-priced NDCs.

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
ANDA213413
TE code
AA
Approval date
Feb 20, 2020
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 71205-0909-00," retrieved September 3, 2026, https://drugdashboards.com/drug/71205090900.

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