Chloraprep Solution
NDC Package 51662-1675-1

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Chloraprep solution is for the preparation of the patient's skin prior to surgery. This formulation utilizes a solution delivery system. Marketed by Hf Acquisition Co Llc, Dba Healthfirst, this product is identified by NDC 51662-1675 and is authorized under FDA application NDA021555.

Identification & Billing

NDC Package Code
51662-1675-1
Package Description
1 APPLICATOR in 1 POUCH / 1.75 mL in 1 APPLICATOR
Product Code
51662-1675
11-Digit Billing Format
51662167501

Clinical Specifications

Proprietary Name
Chloraprep
Non-Proprietary Name
Chloraprep
Substance Name
Chlorhexidine Gluconate; Isopropyl Alcohol
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
Pharmacologic Class
Decreased Cell Wall Integrity - [PE] (Physiologic Effect)
Usage Information
For the preparation of the patient's skin prior to surgery. Helps to reduce bacteria that potentially can cause skin infection.

Regulatory & Marketing

Labeler Name
Hf Acquisition Co Llc, Dba Healthfirst
Product Type
Human Otc Drug
FDA Application #
NDA021555
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-13-2024
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 51662-1675-1 identifies a specific commercial package of 1 applicator in 1 pouch / 1.75 ml in 1 applicator of Chloraprep, a human over the counter drug labeled by Hf Acquisition Co Llc, Dba Healthfirst. This solution is formulated for topical use and contains chlorhexidine gluconate; isopropyl alcohol as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Hf Acquisition Co Llc, Dba Healthfirst on May 13, 2024. The current certification is valid through December 31, 2026.

How is this Hf Acquisition Co Llc, Dba Healthfirst product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51662167501. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-4-1)
51662-1675-1
11-Digit CMS (5-4-2)
51662-1675-01

Note: The zero is added to the Package segment to maintain the 5-4-2 structure.