NDC Package 16129-002-10 Sodium Fluoride F 18

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 discontinued by the firm.

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:

16129-002-10

Package Description:

10 mL in 1 VIAL, MULTI-DOSE

Product Code:

16129-002

Proprietary Name:

Sodium Fluoride F 18

Usage Information:

This medication is used to prevent cavities. It makes teeth stronger and more resistant to decay caused by acid and bacteria. Talk to your dentist or doctor about the benefits and risks of this product. This medication is not recommended for use in infants less than 6 months of age. This medication is not recommended for use in areas where the fluoride content in the water supply is greater than 0.6 parts per million. See Notes section for more information.

11-Digit NDC Billing Format:

16129000210

Labeler Name:

Shertech Laboratories, Llc

Sample Package:

FDA Application Number:

ANDA204315

Marketing Category:

ANDA - A product marketed under an approved Abbreviated New Drug Application.

Start Marketing Date:

03-23-2011

End Marketing Date:

01-29-2019

Listing Expiration Date:

01-29-2019

Exclude Flag:

Code Structure:

16129 - Shertech Laboratories, Llc
- 16129-002 - Sodium Fluoride
  - 16129-002-10 - 10 mL in 1 VIAL, MULTI-DOSE

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
16129-002-30	30 mL in 1 VIAL, MULTI-DOSE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 16129-002-10?

The NDC Packaged Code 16129-002-10 is assigned to a package of 10 ml in 1 vial, multi-dose of Sodium Fluoride F 18, labeled by Shertech Laboratories, Llc. The product's dosage form is and is administered via form.

Is NDC 16129-002 included in the NDC Directory?

No, Sodium Fluoride F 18 with product code 16129-002 is excluded from the NDC Directory because it was discontinued by the manufacturer. The product was first marketed by Shertech Laboratories, Llc on March 23, 2011 and its listing in the NDC Directory is set to expire on January 29, 2019 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 16129-002-10?

The 11-digit format is 16129000210. 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	16129-002-10	5-4-2	16129-0002-10

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