Bismuth Subsalicylate/metronidazole/tetracycline Hydrochloride
NDC Package 70556-103-14

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.

Bismuth Subsalicylate/metronidazole/tetracycline Hydrochloride is the components of Bismuth Subsalicylate Chewable Tablets/ Metronidazole Tablets/Tetracycline Hydrochloride Capsules (bismuth subsalicylate, metronidazole, and tetracycline hydrochloride), in combination with an H2 antagonist, are indicated for the eradication of H. Marketed by Ailex Pharmaceuticals, Llc, this product is identified by NDC 70556-103 and is authorized under FDA application ANDA202584.

Identification & Billing

NDC Package Code
70556-103-14
Package Description
14 BLISTER PACK in 1 CARTON / 4 PACKAGE in 1 BLISTER PACK / 1 KIT in 1 PACKAGE
Product Code
70556-103
11-Digit Billing Format
70556010314
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Bismuth Subsalicylate/metronidazole/tetracycline Hydrochloride
Dosage Form
-
Usage Information
The components of Bismuth Subsalicylate Chewable Tablets/ Metronidazole Tablets/Tetracycline Hydrochloride Capsules (bismuth subsalicylate, metronidazole, and tetracycline hydrochloride), in combination with an H2 antagonist, are indicated for the eradication of H. pylori for treatment of patients with H. pylori infection and duodenal ulcer disease (active or a history of duodenal ulcer). The eradication of H. pylori has been demonstrated to reduce the risk of duodenal ulcer recurrence in patients with active duodenal ulcer disease (see CLINICAL STUDIES and DOSAGE AND ADMINISTRATION).To reduce the development of drug-resistant bacteria and maintain the effectiveness of Bismuth Subsalicylate Chewable Tablets/Metronidazole Tablets/Tetracycline Hydrochloride Capsules and other antibacterial drugs, Bismuth Subsalicylate Chewable Tablets/Metronidazole Tablets/Tetracycline Hydrochloride Capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Regulatory & Marketing

Labeler Name
Ailex Pharmaceuticals, Llc
FDA Application #
ANDA202584
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-30-2018
Listing Expiration
12-31-2020
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 70556-103-14 identifies a specific commercial package of 14 blister pack in 1 carton / 4 package in 1 blister pack / 1 kit in 1 package of Bismuth Subsalicylate/metronidazole/tetracycline Hydrochloride, labeled by Ailex Pharmaceuticals, Llc. 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 Ailex Pharmaceuticals, Llc on November 30, 2018. The current certification is valid through December 31, 2020.

How is this Ailex Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70556010314. 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)
70556-103-14
11-Digit CMS (5-4-2)
70556-0103-14

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