Onko Health Alcohol Antiseptic Wipe
NDC Package 77283-002-08

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Onko Health Alcohol Antiseptic Wipe is for single pack;• Tear open pouch, remove towel.• Wipe injection site vigorously and discard. Marketed by Onko Pharmaceuticals Usa Inc., this product is identified by NDC 77283-002 and is authorized under FDA application part333A.

Identification & Billing

NDC Package Code
77283-002-08
Package Description
500 NOT APPLICABLE in 1 BOTTLE, PLASTIC / 3.12 mL in 1 NOT APPLICABLE
Product Code
77283-002
11-Digit Billing Format
77283000208

Clinical Specifications

Proprietary Name
Onko Health Alcohol Antiseptic Wipe
Dosage Form
-
Usage Information
For single pack;• Tear open pouch, remove towel.• Wipe injection site vigorously and discard. / Wet hands and wrists thoroughly for 15 seconds and discard.• Supervise children under 6 years of age.For multi pack;• Open clip-lid.• Remove moist towels to clean skin as required.• Wipe injection site vigorously and discard. / Wet hands and wrists thoroughly for 15 seconds and discard.• Close lid when not in use to keep remaining towels moist.• Supervise children under 6 years of age.

Regulatory & Marketing

Labeler Name
Onko Pharmaceuticals Usa Inc.
FDA Application #
part333A
Marketing Category
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date
07-13-2020
Listing Expiration
12-31-2021
Exclude Flag
I
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (77283-002). Click a package code to view its specific billing and regulatory data.

77283-002-01
1 NOT APPLICABLE in 1 POUCH / 5 mL in 1 NOT APPLICABLE
77283-002-02
100 NOT APPLICABLE in 1 BOTTLE, PLASTIC / 3.12 mL in 1 NOT APPLICABLE
77283-002-03
120 NOT APPLICABLE in 1 BOTTLE, PLASTIC / 3.12 mL in 1 NOT APPLICABLE
77283-002-04
150 NOT APPLICABLE in 1 BOTTLE, PLASTIC / 3.12 mL in 1 NOT APPLICABLE
77283-002-05
350 NOT APPLICABLE in 1 BOTTLE, PLASTIC / 3.12 mL in 1 NOT APPLICABLE
77283-002-06
400 NOT APPLICABLE in 1 BOTTLE, PLASTIC / 3.12 mL in 1 NOT APPLICABLE
77283-002-07
450 NOT APPLICABLE in 1 BOTTLE, PLASTIC / 3.12 mL in 1 NOT APPLICABLE
77283-002-09
550 NOT APPLICABLE in 1 BOTTLE, PLASTIC / 3.12 mL in 1 NOT APPLICABLE
77283-002-10
600 NOT APPLICABLE in 1 BOTTLE, PLASTIC / 3.12 mL in 1 NOT APPLICABLE
77283-002-11
700 NOT APPLICABLE in 1 BOTTLE, PLASTIC / 3.12 mL in 1 NOT APPLICABLE
77283-002-12
800 NOT APPLICABLE in 1 BOTTLE, PLASTIC / 3.12 mL in 1 NOT APPLICABLE
77283-002-13
900 NOT APPLICABLE in 1 BOTTLE, PLASTIC / 3.12 mL in 1 NOT APPLICABLE
77283-002-14
1000 NOT APPLICABLE in 1 BOTTLE, PLASTIC / 3.12 mL in 1 NOT APPLICABLE
77283-002-15
2000 NOT APPLICABLE in 1 BOTTLE, PLASTIC / 3.12 mL in 1 NOT APPLICABLE
77283-002-16
5000 NOT APPLICABLE in 1 BOTTLE, PLASTIC / 3.12 mL in 1 NOT APPLICABLE

* 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 77283-002-08 identifies a specific commercial package of 500 not applicable in 1 bottle, plastic / 3.12 ml in 1 not applicable of Onko Health Alcohol Antiseptic Wipe, labeled by Onko Pharmaceuticals Usa Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Onko Pharmaceuticals Usa Inc. on July 13, 2020. The current certification is valid through December 31, 2021.

How is this Onko Pharmaceuticals Usa Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 77283000208. 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 (5-3-2)
77283-002-08
11-Digit CMS (5-4-2)
77283-0002-08

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