Assured
NDC Package 70697-800-07

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

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

Assured is thoroughly wipe hands and face as desired.Allow to dry without wiping.Discard wipe in trash receptacle after use.Do not flush. Marketed by Indelpa, S.a. De C.v., this product is identified by NDC 70697-800 and is authorized under FDA application part333E.

Identification & Billing

NDC Package Code
70697-800-07
Package Description
12 POUCH in 1 CASE / 103.2 mg in 1 POUCH
Product Code
70697-800
11-Digit Billing Format
70697080007
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Assured
Dosage Form
-
Usage Information
Thoroughly wipe hands and face as desired.Allow to dry without wiping.Discard wipe in trash receptacle after use.Do not flush.

Regulatory & Marketing

Labeler Name
Indelpa, S.a. De C.v.
FDA Application #
part333E
Marketing Category
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date
06-10-2016
Listing Expiration
12-31-2023
Exclude Flag
I
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (70697-800). Click a package code to view its specific billing and regulatory data.

70697-800-03
3 PACKAGE in 1 BAG / 10 POUCH in 1 PACKAGE / 3 mg in 1 POUCH
70697-800-04
40 POUCH in 1 PACKAGE / .375 mg in 1 POUCH
70697-800-05
20 POUCH in 1 PACKAGE / .375 mg in 1 POUCH
70697-800-06
2 PACKAGE in 1 PACKAGE / 15 POUCH in 1 PACKAGE / 2 mg in 1 POUCH

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 70697-800-07 identifies a specific commercial package of 12 pouch in 1 case / 103.2 mg in 1 pouch of Assured, labeled by Indelpa, S.a. De C.v.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Indelpa, S.a. De C.v. on June 10, 2016. The current certification is valid through December 31, 2023.

How is this Indelpa, S.a. De C.v. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70697080007. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
70697-800-07
11-Digit CMS (5-4-2)
70697-0800-07

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.