Ranitidine
NDC Package 58118-0803-8

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 discontinued by the firm.

Ranitidine is tablets, USP is indicated in:Short-term treatment of active duodenal ulcer. Marketed by Clinical Solutions Wholesale, Llc, this product is identified by NDC 58118-0803 and is authorized under FDA application ANDA205512.

Identification & Billing

NDC Package Code
58118-0803-8
Package Description
30 TABLET in 1 BLISTER PACK
Product Code
58118-0803
11-Digit Billing Format
58118080308

Clinical Specifications

Proprietary Name
Ranitidine Immediate Release
Dosage Form
-
Usage Information
Ranitidine tablets, USP is indicated in:Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Trials 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. Trials 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 trials 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
Clinical Solutions Wholesale, Llc
FDA Application #
ANDA205512
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-29-2016
End Marketing Date
06-30-2020
Listing Expiration
06-30-2020
Exclude Flag
D
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 58118-0803-8 identifies a specific commercial package of 30 tablet in 1 blister pack of Ranitidine Immediate Release, labeled by Clinical Solutions Wholesale, 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 Clinical Solutions Wholesale, Llc on August 29, 2016. The current certification is valid through June 30, 2020.

How is this Clinical Solutions Wholesale, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58118080308. 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)
58118-0803-8
11-Digit CMS (5-4-2)
58118-0803-08

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