DrugDashboards

ChloraPrep One-Step

chlorhexidine gluconate and isopropyl alcohol · ISOPROPYL ALCOHOL .7 mL/mL; CHLORHEXIDINE GLUCONATE 20 mg/mL · Solution · Topical · CareFusion 213, LLC

NDC 54365-0400-34 · 25 POUCH in 1 CARTON / 1 APPLICATOR in 1 POUCH / 10.5 mL in 1 APPLICATOR · NDA · View full market →

The short version

5 companies supply this market — a reasonable cushion if one runs into trouble. A Class II recall hit this product in the past year (CareFusion 213, LLC).

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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.

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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.

Regulatory

Application
NDA020832
TE code
Approval date
Jul 14, 2000
Patents / exclusivity
3 patents, 0 exclusivities
TypeNumber / codeExpires
patent7422388Apr 25, 2027
patent7422388Apr 25, 2027
patent7422388Apr 25, 2027

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

  • Class II · OngoingJun 11, 2026
    CareFusion 213, LLCLack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel

Manufacturers of chlorhexidine gluconate and isopropyl alcohol (Solution)

LabelerStrengthFirst seenLast seen
CareFusion 213, LLCCHLORHEXIDINE GLUCONATE 20 mg/mL; ISOPROPYL ALCOHOL .7 mL/mLJul 15, 2026Sep 3, 2026
Professional Disposables International, Inc.CHLORHEXIDINE GLUCONATE 31.5 mg/mL; ISOPROPYL ALCOHOL .7 mL/mLJul 15, 2026Sep 3, 2026
C.R. BardCHLORHEXIDINE GLUCONATE 20 mg/mL; ISOPROPYL ALCOHOL .7 mL/mLJul 15, 2026Sep 2, 2026
CareFusion 213, LLCISOPROPYL ALCOHOL .7 mL/mL; CHLORHEXIDINE GLUCONATE 20 mg/mLAug 26, 2026Sep 2, 2026
CareFusion 213 LLCCHLORHEXIDINE GLUCONATE 20 mg/mL; ISOPROPYL ALCOHOL .7 mL/mLJul 15, 2026Aug 31, 2026
Solventum US LLCCHLORHEXIDINE GLUCONATE 20 mg/mL; ISOPROPYL ALCOHOL .7 mL/mLJul 15, 2026Aug 28, 2026
CareFusion 213, LLCISOPROPYL ALCOHOL 20 mg/mL; CHLORHEXIDINE GLUCONATE .7 mL/mLJul 22, 2026Aug 19, 2026

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

Cite this page

DrugDashboards, "ChloraPrep One-Step — NDC 54365-0400-34," retrieved September 3, 2026, https://drugdashboards.com/drug/54365040034.

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