Diphenoxylate Hydrochloride and Atropine Sulfate · DIPHENOXYLATE HYDROCHLORIDE 2.5 mg/5mL; ATROPINE SULFATE .025 mg/5mL · Solution · Oral · Hikma Pharmaceuticals USA Inc.
NDC 00054-3194-46 · 1 BOTTLE in 1 CARTON / 60 mL in 1 BOTTLE · ANDA · View full market →
Only one company currently supplies this market — there is no backup if it stumbles. The price has jumped 388% in a year, to $1.08 per unit — sharp rises like this often mean supply is already tightening.
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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.
*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.
Manufacturer list price as filed — not what pharmacies actually pay after discounts.
Not scored — fragility is computed for NADAC-priced NDCs.
Establishments this product's FDA label declares, located via FDA registration data. How we built this →
No FDA shortage reports for this drug or its presentations.
No enforcement reports list this package NDC.
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Hikma Pharmaceuticals USA Inc. | DIPHENOXYLATE HYDROCHLORIDE 2.5 mg/5mL; ATROPINE SULFATE .025 mg/5mL | Aug 26, 2026 | Sep 2, 2026 |
| Hikma Pharmaceuticals USA Inc. | DIPHENOXYLATE HYDROCHLORIDE .025 mg/5mL; ATROPINE SULFATE 2.5 mg/5mL | Jul 22, 2026 | Aug 19, 2026 |
| Hikma Pharmaceuticals USA Inc. | ATROPINE SULFATE .025 mg/5mL; DIPHENOXYLATE HYDROCHLORIDE 2.5 mg/5mL | Jul 15, 2026 | Jul 15, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
DrugDashboards, "Diphenoxylate Hydrochloride and Atropine Sulfate — NDC 00054-3194-46," retrieved September 3, 2026, https://drugdashboards.com/drug/00054319446.
Free to cite with attribution — see how the data is put together.