Sentradine
NDC Package 68405-033-26

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.

Sentradine is iNDICATIONS AND USAGE Ranitidine Tablets, USP is indicated in:1. Marketed by Physician Therapeutics Llc, this product is identified by NDC 68405-033.

Identification & Billing

NDC Package Code
68405-033-26
Package Description
1 KIT in 1 KIT * 60 CAPSULE in 1 BOTTLE * 30 TABLET in 1 BOTTLE (52959-502-30)
Product Code
68405-033
11-Digit Billing Format
68405003326
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Sentradine
Dosage Form
-
Usage Information
INDICATIONS AND USAGE Ranitidine Tablets, USP is indicated in:1. 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.2. 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.3. The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis).4. 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.5. Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers. Placebo-controlled studies have been carried out for 1 year.6. Treatment of GERD. Symptomatic relief commonly occurs within 24 hours after starting therapy with Ranitidine Tablets, USP 150 mg b.i.d.7. Treatment of endoscopically diagnosed erosive esophagitis. Symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with Ranitidine Tablets, USP 150 mg q.i.d.8. 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. INDICATIONS FOR USE   Sentra PM is intended for the clinical dietary management of the metabolic processes associated with sleep disorders.

Regulatory & Marketing

Labeler Name
Physician Therapeutics Llc
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
07-07-2011
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 68405-033-26 identifies a specific commercial package of 1 kit in 1 kit * 60 capsule in 1 bottle * 30 tablet in 1 bottle (52959-502-30) of Sentradine, labeled by Physician Therapeutics 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 Physician Therapeutics Llc on July 07, 2011. The current certification is valid through December 31, 2017.

How is this Physician Therapeutics Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68405003326. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. 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)
68405-033-26
11-Digit CMS (5-4-2)
68405-0033-26

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