NDC Package 78371-201-03 Halodine Oral Rinse

View Billable Units, 11-Digit Format, RxNorm

Package Information
Other Packages
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:

78371-201-03

Package Description:

10 AMPULE in 1 CARTON / 3.2 mL in 1 AMPULE

Product Code:

78371-201

Proprietary Name:

Halodine Oral Rinse

Usage Information:

For oral antisepsis in adults and children 3 years of age and older:Twist off the narrow end of single ampoule.Empty contents of ampoule into small cup. Add twice the amount of water to cup for total fill of 10 ml.Pour contents of cup into mouth. Swish vigorously in mouth for 15 seconds.Slightly lift chin and tilt head back to gargle, then spit out.Children under 3 years of age: Consult a dentist or doctor

11-Digit NDC Billing Format:

78371020103

NDC to RxNorm Crosswalk:

RxCUI: 2380869 - povidone-iodine 1.75 % Topical Solution

RxCUI: 2380869 - povidone-iodine 17.5 MG/ML Topical Solution

RxCUI: 2380869 - povidone-iodine 1.75 % (titratable iodine 0.175 % ) Topical Solution

Labeler Name:

Halodine Llc

Sample Package:

Start Marketing Date:

05-15-2020

Listing Expiration Date:

12-31-2021

Exclude Flag:

Code Structure:

78371 - Halodine Llc
- 78371-201 - Halodine Oral Rinse
  - 78371-201-03 - 10 AMPULE in 1 CARTON / 3.2 mL in 1 AMPULE

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
78371-201-01	100 AMPULE in 1 CARTON / 3.2 mL in 1 AMPULE
78371-201-02	200 AMPULE in 1 CARTON / 3.8 mL in 1 AMPULE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 78371-201-03?

The NDC Packaged Code 78371-201-03 is assigned to a package of 10 ampule in 1 carton / 3.2 ml in 1 ampule of Halodine Oral Rinse, labeled by Halodine Llc. The product's dosage form is and is administered via form.

Is NDC 78371-201 included in the NDC Directory?

No, Halodine Oral Rinse with product code 78371-201 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Halodine Llc on May 15, 2020 and its listing in the NDC Directory is set to expire on December 31, 2021 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 78371-201-03?

The 11-digit format is 78371020103. 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	78371-201-03	5-4-2	78371-0201-03

Table of Contents