Alcohol Prep Pad Non-sterile Patch
NDC Package 34645-0001-1

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

Package Information

Alcohol Prep Pad Non-sterile (isopropyl alcohol) patches is wipe injection site vigorously and discard. This formulation utilizes a patch delivery system. Marketed by Jianerkang Medical Co., Ltd, this product is identified by NDC 34645-0001 and is authorized under FDA application 505G(a)(3).

Identification & Billing

NDC Package Code
34645-0001-1
Package Description
1 PATCH in 1 POUCH / .5 mL in 1 PATCH
Product Code
34645-0001
11-Digit Billing Format
34645000101
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Alcohol Prep Pad Non-sterile
Non-Proprietary Name
Isopropyl Alcohol
Substance Name
Isopropyl Alcohol
Dosage Form
Patch - A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms ‘extended release film’ and ‘system’.
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)
ISOPROPYL ALCOHOL .7 mL/mL
Usage Information
Wipe injection site vigorously and discard

Regulatory & Marketing

Labeler Name
Jianerkang Medical Co., Ltd
Product Type
Human Otc Drug
FDA Application #
505G(a)(3)
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
04-30-2020
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 34645-0001-1 identifies a specific commercial package of 1 patch in 1 pouch / .5 ml in 1 patch of Alcohol Prep Pad Non-sterile, a human over the counter drug labeled by Jianerkang Medical Co., Ltd. This patch is formulated for topical use and contains 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 Jianerkang Medical Co., Ltd on April 30, 2020. The current certification is valid through December 31, 2026.

How is this Jianerkang Medical Co., Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 34645000101. 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)
34645-0001-1
11-Digit CMS (5-4-2)
34645-0001-01

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