Ranitidine
NDC Package 41163-353-31

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.

Ranitidine is •adults and children 12 years and over: •to relieve symptoms, swallow 1 tablet with a glass of water•to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn•can be used up to twice daily (do not take more than 2 tablets in 24 hours)•children under 12 years: ask a doctor. Marketed by Supervalu Inc., this product is identified by NDC 41163-353 and is authorized under FDA application ANDA201745.

Identification & Billing

NDC Package Code
41163-353-31
Package Description
30 TABLET, FILM COATED in 1 BOTTLE
Product Code
41163-353
11-Digit Billing Format
41163035331
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ranitidine
Dosage Form
-
Usage Information
•adults and children 12 years and over: •to relieve symptoms, swallow 1 tablet with a glass of water•to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn•can be used up to twice daily (do not take more than 2 tablets in 24 hours)•children under 12 years: ask a doctor

Regulatory & Marketing

Labeler Name
Supervalu Inc.
FDA Application #
ANDA201745
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-10-2012
Listing Expiration
12-31-2019
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 41163-353-31 identifies a specific commercial package of 30 tablet, film coated in 1 bottle of Ranitidine, labeled by Supervalu Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package. 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 Supervalu Inc. on July 10, 2012. The current certification is valid through December 31, 2019.

How is this Supervalu Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 41163035331. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 total billable units per package. 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)
41163-353-31
11-Digit CMS (5-4-2)
41163-0353-31

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