Ranitidine
NDC Package 54868-4048-2

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.

Ranitidine is tablets, USP are indicated in:Short-term treatment of active duodenal ulcer. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-4048 and is authorized under FDA application ANDA075208.

Identification & Billing

NDC Package Code
54868-4048-2
Package Description
30 TABLET in 1 BOTTLE, PLASTIC
Product Code
54868-4048
11-Digit Billing Format
54868404802
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
Ranitidine Tablets, USP are indicated in:Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Studies available to date have not assessed the safety of ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks.Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. No placebo-controlled comparative studies have been carried out for periods of longer than 1 year.The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis). Short-term treatment of active, benign gastric ulcer. Most patients heal within 6 weeks and the usefulness of further treatment has not been demonstrated. Studies available to date have not assessed the safety of ranitidine in uncomplicated, benign gastric ulcer for periods of more than 6 weeks.Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers. Placebo-controlled studies have been carried out for 1 year.Treatment of GERD. Symptomatic relief commonly occurs within 24 hours after starting therapy with ranitidine 150 mg twice daily.Treatment of endoscopically diagnosed erosive esophagitis. Symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with Ranitidine 150 mg 4 times daily.Maintenance of healing of erosive esophagitis. Placebo-controlled trials have been carried out for 48 weeks.Concomitant antacids should be given as needed for pain relief to patients with active duodenal ulcer; active, benign gastric ulcer; hypersecretory states; GERD; and erosive esophagitis.

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
ANDA075208
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-21-1999
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (54868-4048). Click a package code to view its specific billing and regulatory data.

54868-4048-0
60 TABLET in 1 BOTTLE, PLASTIC
54868-4048-1
100 TABLET in 1 BOTTLE, PLASTIC
54868-4048-3
90 TABLET in 1 BOTTLE, PLASTIC
54868-4048-4
180 TABLET in 1 BOTTLE, PLASTIC

* 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 54868-4048-2 identifies a specific commercial package of 30 tablet in 1 bottle, plastic of Ranitidine, labeled by Physicians Total Care, 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 Physicians Total Care, Inc. on September 21, 1999. The current certification is valid through December 31, 2017.

How is this Physicians Total Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868404802. 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 (5-4-1)
54868-4048-2
11-Digit CMS (5-4-2)
54868-4048-02

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