NDC Package 59883-168-16 Pro-den Rx

View Billable Units, 11-Digit Format, RxNorm

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:
59883-168-16
Package Description:
473 mL in 1 TUBE
Product Code:
Proprietary Name:
Pro-den Rx
Usage Information:
This product is used as AnticavityApproved UsesAids in prevention of dental caries (cavities).The combined daily use of a fluoride preventive treatment rinse and a fluoride toothpaste can help reduce the incidence of dental cavities.WarningsPlease keep out of reach of children.If more than used for rinsing is accidentally swallowed get medical help or contact a Poison Control Center right away. Use only under guidance or supervision of a dentist or doctor.Directions: This is a fluoride treatment rinse, not a mouthwash.  Read directions carefully before using.Adults and Children6 yrs and older                                            Use once a day after brushing your teeth with a toothpaste. Vigorously swish 10 ml of rinse between your teeth for one minute, then spit out. Do not swallow the rinse. Do not eat or drink for 30 minutes after rinsing.Children 6 to 12                                                    Instruct and supervise in good rinsing (to minimize swallowing). Children Under 6Consult a dentist or doctor.Inactive Ingredients:Distilled water, monosodium phosphate, sodium benzoate, sodium saccharin, artificial color, artificial flavor.Made for and Distributed in US by: Zila Therapeutics, Inc.,P.O. Box 3889, Batesville, AR 725031-800-228-5595
11-Digit NDC Billing Format:
59883016816
Labeler Name:
Zila Therapeutics, Inc.
Sample Package:
No
Start Marketing Date:
11-21-2008
Listing Expiration Date:
12-31-2017
Exclude Flag:
I
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.

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Frequently Asked Questions

What is NDC 59883-168-16?

The NDC Packaged Code 59883-168-16 is assigned to a package of 473 ml in 1 tube of Pro-den Rx, labeled by Zila Therapeutics, Inc.. The product's dosage form is and is administered via form.

Is NDC 59883-168 included in the NDC Directory?

No, Pro-den Rx with product code 59883-168 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Zila Therapeutics, Inc. on November 21, 2008 and its listing in the NDC Directory is set to expire on December 31, 2017 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 59883-168-16?

The 11-digit format is 59883016816. 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
5-3-259883-168-165-4-259883-0168-16