Is CareFusion 213, LLC FDA approved?

CareFusion 213, LLC holds no registered establishment of its own; 3 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does CareFusion 213, LLC make?

3 products are listed under CareFusion 213, LLC in the openFDA NDC Directory, most often as solution; sponge. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

CareFusion 213, LLC

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 0
Active NDC listings: 3
Labeller names: 2
Live patents: 0
Countries: 0

Catalogue

Drug listings by form and route

3 active NDC listings: 3 human otc drug. By marketing category: NDA 2, OTC MONOGRAPH DRUG 1.

Dosage form	NDCs
solution	2
sponge	1

Route	NDCs
topical	3

Labeller name on the listing	NDCs
carefusion 213 llc	2
carefusion 213, llc	1

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
ChloraPrep One-Step	chlorhexidine gluconate and isopropyl alcohol	solution, topical	54365-400NDA
ChloraPrep Swabstick	Chlorhexidine gluconate and isopropyl alcohol	solution, topical	54365-401NDA
PurPrep	povidone iodine and isopropyl alcohol	sponge, topical	54365-014OTC MONOGRAPH DRUG

Enquiry

Common questions

Is CareFusion 213, LLC FDA approved?: CareFusion 213, LLC holds no registered establishment of its own; 3 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does CareFusion 213, LLC make?: 3 products are listed under CareFusion 213, LLC in the openFDA NDC Directory, most often as solution; sponge. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.