NDC Package 80284-001-02 Gabgerm Antiseptic Hand Sanitizer

View Billable Units, 11-Digit Format, RxNorm

Package Information
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Frequently Asked Questions

Package Information

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

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:

80284-001-02

Package Description:

1 BOTTLE, SPRAY in 1 CARTON / 1000 mL in 1 BOTTLE, SPRAY

Product Code:

80284-001

Proprietary Name:

Gabgerm Antiseptic Hand Sanitizer

Usage Information:

Wet hands thoroughly with product and allow to dry without wiping.

11-Digit NDC Billing Format:

80284000102

NDC to RxNorm Crosswalk:

RxCUI: 2393130 - isopropyl alcohol 72 % Topical Solution
RxCUI: 2393130 - isopropyl alcohol 0.72 ML/ML Topical Solution

Labeler Name:

International Biotech Factory, S.a. De C.v.

Sample Package:

FDA Application Number:

505G(a)(3)

Marketing Category:

OTC MONOGRAPH DRUG -

Start Marketing Date:

01-04-2021

Listing Expiration Date:

12-31-2024

Exclude Flag:

Code Structure:

80284 - International Biotech Factory, S.a. De C.v.
- 80284-001 - Gabgerm Antiseptic Hand Sanitizer
  - 80284-001-02 - 1 BOTTLE, SPRAY in 1 CARTON / 1000 mL in 1 BOTTLE, SPRAY

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 disclaimer below.

Other Product Packages

The following packages are also available for this product:

NDC Package Code	Package Description
80284-001-01	60 mL in 1 BOTTLE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 80284-001-02?

The NDC Packaged Code 80284-001-02 is assigned to a package of 1 bottle, spray in 1 carton / 1000 ml in 1 bottle, spray of Gabgerm Antiseptic Hand Sanitizer, labeled by International Biotech Factory, S.a. De C.v.. The product's dosage form is and is administered via form.

Is NDC 80284-001 included in the NDC Directory?

No, Gabgerm Antiseptic Hand Sanitizer with product code 80284-001 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by International Biotech Factory, S.a. De C.v. on January 04, 2021 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 80284-001-02?

The 11-digit format is 80284000102. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	80284-001-02	5-4-2	80284-0001-02

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