NDC Package 61919-225-30 Raberprazole Sodium D/r

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 discontinued by the firm.

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:

61919-225-30

Package Description:

30 TABLET, DELAYED RELEASE in 1 BOTTLE

Product Code:

61919-225

Proprietary Name:

Raberprazole Sodium D/r

Usage Information:

1.1 Healing of Erosive or Ulcerative GERD in AdultsRabeprazole sodium delayed-release tablets are indicated for short-term (4 to 8 weeks) treatment in the healing and symptomatic relief of erosive or ulcerative gastroesophageal reflux disease (GERD). For those patients who have not healed after 8 weeks of treatment, an additional 8-week course of rabeprazole sodium delayed-release tablets may be considered.1.2 Maintenance of Healing of Erosive or Ulcerative GERD in AdultsRabeprazole sodium delayed-release tablets are indicated for maintaining healing and reduction in relapse rates of heartburn symptoms in patients with erosive or ulcerative gastroesophageal reflux disease (GERD Maintenance). Controlled studies do not extend beyond 12 months.1.3 Treatment of Symptomatic GERD in AdultsRabeprazole sodium delayed-release tablets are indicated for the treatment of daytime and nighttime heartburn and other symptoms associated with GERD in adults for up to 4 weeks.1.4 Healing of Duodenal Ulcers in AdultsRabeprazole sodium delayed-release tablets are indicated for short-term (up to four weeks) treatment in the healing and symptomatic relief of duodenal ulcers. Most patients heal within four weeks.1.5 Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence in AdultsRabeprazole sodium delayed-release tablets, in combination with amoxicillin and clarithromycin as a three drug regimen, are indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or history within the past 5 years) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see Clinical Studies (14.5) and Dosage and Administration (2.5)].In patients who fail therapy, susceptibility testing should be done. If resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted [see Clinical Pharmacology (12.2) and the clarithromycin package insert, Clinical Pharmacology (12.2)].1.6 Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome in AdultsRabeprazole sodium delayed-release tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.1.7 Short-term Treatment of Symptomatic GERD in Adolescent Patients 12 Years of Age and OlderRabeprazole sodium delayed-release tablets are indicated for the treatment of symptomatic GERD in adolescents 12 years of age and above for up to 8 weeks.

11-Digit NDC Billing Format:

61919022530

Billing Unit:

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

NDC to RxNorm Crosswalk:

30 EA

Labeler Name:

Direct Rx

Sample Package:

FDA Application Number:

ANDA202376

Marketing Category:

ANDA - A product marketed under an approved Abbreviated New Drug Application.

Start Marketing Date:

10-30-2017

End Marketing Date:

12-31-2023

Listing Expiration Date:

12-31-2023

Exclude Flag:

Code Structure:

61919 - Direct Rx
- 61919-225 - Raberprazole Sodium D/r
  - 61919-225-30 - 30 TABLET, DELAYED RELEASE 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
61919-225-60	60 TABLET, DELAYED RELEASE in 1 BOTTLE
61919-225-90	90 TABLET, DELAYED RELEASE in 1 BOTTLE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 61919-225-30?

The NDC Packaged Code 61919-225-30 is assigned to a package of 30 tablet, delayed release in 1 bottle of Raberprazole Sodium D/r, labeled by Direct Rx. 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 30 billable units per package.

Is NDC 61919-225 included in the NDC Directory?

No, Raberprazole Sodium D/r with product code 61919-225 is excluded from the NDC Directory because it was discontinued by the manufacturer. The product was first marketed by Direct Rx on October 30, 2017 and its listing in the NDC Directory is set to expire on December 31, 2023 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 61919-225-30?

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 30.

What is the 11-digit format for NDC 61919-225-30?

The 11-digit format is 61919022530. 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	61919-225-30	5-4-2	61919-0225-30

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