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  5. NDC Package Code: 68915-280-02 Guardian Vaginal

NDC Package 68915-280-02 Guardian Vaginal

Benzalkonium Chloride Douche Vaginal - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

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:
68915-280-02
Package Description:
1 BOTTLE in 1 BOX / 5.5 mL in 1 BOTTLE (68915-280-01)
Product Code:
68915-280
Proprietary Name:
Guardian Vaginal
Non-Proprietary Name:
Benzalkonium Chloride
Substance Name:
Benzalkonium Chloride
Usage Information:
Insert the gel into the vagina when cleansing is desired, one unit (5.5ml) each time. Please read the following instructions carefully before use. 1. Take off any plastic around the tube. 2. Remove the small plastic tip from the top of the applicator. 3. Gently insert the small end of the applicator deep into the vagina. While in this position, squeeze the entire contents of the applicator to release the gel. Remove the applicator and discard it in a waste container. Do not use this product if the package seal is broken.Children under 12 years of age: ask doctor.
11-Digit NDC Billing Format:
68915028002
NDC to RxNorm Crosswalk:
Product Type:
Human Otc Drug
Labeler Name:
Eastern Century Pharmaceuticals
Dosage Form:
Douche - A liquid preparation, intended for the irrigative cleansing of the vagina, that is prepared from powders, liquid solutions, or liquid concentrates and contains one or more chemical substances dissolved in a suitable solvent or mutually miscible solvents.
Administration Route(s):
Vaginal - Administration into the vagina.
Active Ingredient(s):
BENZALKONIUM CHLORIDE 1 mg/mL
Sample Package:
No
FDA Application Number:
M003
Marketing Category:
OTC MONOGRAPH DRUG -
Start Marketing Date:
05-23-2011
Listing Expiration Date:
12-31-2025
Exclude Flag:
N
Code Structure:

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.

Frequently Asked Questions

What is NDC 68915-280-02?

The NDC Packaged Code 68915-280-02 is assigned to a package of 1 bottle in 1 box / 5.5 ml in 1 bottle (68915-280-01) of Guardian Vaginal, a human over the counter drug labeled by Eastern Century Pharmaceuticals. The product's dosage form is douche and is administered via vaginal form.

Is NDC 68915-280 included in the NDC Directory?

Yes, Guardian Vaginal with product code 68915-280 is active and included in the NDC Directory. The product was first marketed by Eastern Century Pharmaceuticals on May 23, 2011 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 68915-280-02?

The 11-digit format is 68915028002. 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 Format10-Digit Original Code11-Digit Format11-Digit Code
5-3-268915-280-025-4-268915-0280-02