Toxicology Saliva Collection Kit
NDC Package 69176-035-01

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

Package Information

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

Toxicology Saliva Collection Kit is carefully consider the potential benefits and risks of Ibuprofentablets and other treatment options before deciding to use Ibuprofen.Use the lowest effective dose for the shortest duration consistent withindividual patient treatment goals (see WARNINGS ). Marketed by Tmig, Inc., this product is identified by NDC 69176-035 and is authorized under FDA application ANDA075682.

Identification & Billing

NDC Package Code
69176-035-01
Package Description
1 KIT in 1 KIT * 1 SWAB in 1 TUBE, WITH APPLICATOR * 1 TABLET, FILM COATED in 1 BLISTER PACK
Product Code
69176-035
11-Digit Billing Format
69176003501
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
RxNorm Crosswalk
RxCUI: 197806 - ibuprofen 600 MG Oral Tablet

Clinical Specifications

Proprietary Name
Toxicology Saliva Collection Kit
Dosage Form
-
Usage Information
Carefully consider the potential benefits and risks of Ibuprofentablets and other treatment options before deciding to use Ibuprofen.Use the lowest effective dose for the shortest duration consistent withindividual patient treatment goals (see WARNINGS ). IBU tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. IBU tablets are indicated for relief of mild to moderate pain. IBU tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of IBU tablets in children have not been conducted.

Regulatory & Marketing

Labeler Name
Tmig, Inc.
FDA Application #
ANDA075682
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-30-2015
Listing Expiration
12-31-2017
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 69176-035-01 identifies a specific commercial package of 1 kit in 1 kit * 1 swab in 1 tube, with applicator * 1 tablet, film coated in 1 blister pack of Toxicology Saliva Collection Kit, labeled by Tmig, Inc.. 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 Tmig, Inc. on January 30, 2015. The current certification is valid through December 31, 2017.

How is this Tmig, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69176003501. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. 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)
69176-035-01
11-Digit CMS (5-4-2)
69176-0035-01

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