NDC Package 71610-378-60 Ranitidine Immediate Release

View Billable Units, 11-Digit Format, RxNorm

Package Information
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Frequently Asked Questions

Package Information

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

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:

71610-378-60

Package Description:

90 TABLET in 1 BOTTLE

Product Code:

71610-378

Proprietary Name:

Ranitidine Immediate Release

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.

11-Digit NDC Billing Format:

71610037860

Billing Unit:

EA - Billing unit of "each" is used when the product is dispensed in discreet units.

NDC to RxNorm Crosswalk:

90 EA

NDC to RxNorm Crosswalk:

RxCUI: 198191 - ranitidine 150 MG Oral Tablet

RxCUI: 198191 - ranitidine 150 MG (as ranitidine HCl 168 MG) Oral Tablet

Labeler Name:

Aphena Pharma Solutions - Tennessee, Llc

Sample Package:

Start Marketing Date:

08-22-2016

Listing Expiration Date:

12-31-2022

Exclude Flag:

Code Structure:

71610 - Aphena Pharma Solutions - Tennessee, Llc
- 71610-378 - Ranitidine
  - 71610-378-60 - 90 TABLET in 1 BOTTLE

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 disclaimer below.

Other Product Packages

The following packages are also available for this product:

NDC Package Code	Package Description
71610-378-30	30 TABLET in 1 BOTTLE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 71610-378-60?

The NDC Packaged Code 71610-378-60 is assigned to a package of 90 tablet in 1 bottle of Ranitidine Immediate Release, labeled by Aphena Pharma Solutions - Tennessee, Llc. The product's dosage form is and is administered via form.This product is billed for "EA" each discreet unit and contains an estimated amount of 90 billable units per package.

Is NDC 71610-378 included in the NDC Directory?

No, Ranitidine Immediate Release with product code 71610-378 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Aphena Pharma Solutions - Tennessee, Llc on August 22, 2016 and its listing in the NDC Directory is set to expire on December 31, 2022 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 71610-378-60?

The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 90.

What is the 11-digit format for NDC 71610-378-60?

The 11-digit format is 71610037860. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	71610-378-60	5-4-2	71610-0378-60

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