What is NDC 54365-400?

54365-400 is the product NDC for ChloraPrep One-Step, Chlorhexidine gluconate 20 mg/mL; Isopropyl alcohol .7 mL/mL solution, listed with the FDA by CareFusion 213, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

ChloraPrep One-Step (Chlorhexidine gluconate and isopropyl alcohol).

What is the active ingredient?

Chlorhexidine gluconate, Isopropyl alcohol.

CareFusion 213, LLC, NDC labeler code 54365. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for ChloraPrep One-Step?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

ChloraPrep One-Step NDC 54365-400 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)54365-400Labeler and product segments. Claims need a package NDC.

Product NDC at billing width54365-0400Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
54365-400-37	5436504003754365040037	1 APPLICATOR in 1 POUCH (54365-400-37) / 26 mL in 1 APPLICATORMarketed from May 24, 2019

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): ChloraPrep One-Step
Generic name (nonproprietary): chlorhexidine gluconate and isopropyl alcohol
Active ingredients: Chlorhexidine gluconate — 20 mg/mLIsopropyl alcohol — .7 mL/mL
Dosage form: Solution
Route: Topical
Labeler: CareFusion 213, LLCNDC labeler code 54365
Product type: Over-the-counter drug
Marketing category: NDA — New Drug ApplicationApplication NDA 020832
Marketing start: May 24, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Cell Wall Integrity (Physiologic effect)
Identifiers: Product ID 54365-400_415f7dfe-05e3-94ab-e063-6394a90a94ebSPL ID 415f7dfe-05e3-94ab-e063-6394a90a94ebSPL set ID 85790749-5a95-7f18-e053-2a91aa0a1a02RxCUI 858726, 998282UNII MOR84MUD8E, ND2M416302

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N454365040037 followed by a unit qualifier and the quantity

Package 54365-0400-37. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Oct 17, 2025.

Indications (excerpt from the label)

Use for the preparation of the patient’s skin prior to surgery. Helps to reduce bacteria that potentially can cause skin infection.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 54365-400

What is NDC 54365-400?: 54365-400 is the product NDC for ChloraPrep One-Step, Chlorhexidine gluconate 20 mg/mL; Isopropyl alcohol .7 mL/mL solution, listed with the FDA by CareFusion 213, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: ChloraPrep One-Step (Chlorhexidine gluconate and isopropyl alcohol).
What is the active ingredient?: Chlorhexidine gluconate, Isopropyl alcohol.
Who is the labeler?: CareFusion 213, LLC, NDC labeler code 54365. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for ChloraPrep One-Step?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.